| Primary | Participants With Modified Rankin Scale (mRS) <=3 - Dichotomized Analysis | Analysis modified on September 29, 2015 to account for adaptive randomization. The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All the non-missing mRS scores at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Chi-squared | | 0.554 | | Risk Difference (RD) | 0.027 | | | 2-Sided | 95 | -0.062 | 0.115 | | | | | Superiority or Other | | | | | Multivariable Logit Model | | 0.465 |
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| Primary | Participant Score on the Modified Rankin Scale (mRS) - Ordinal Analysis | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All the non-missing mRS scores at 180 days were analyzed. | Posted | | Median | Inter-Quartile Range | mRS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Primary | Participants With Modified Rankin Scale (mRS) <=4 - Dichotomized Analysis | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All the non-missing mRS scores at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Primary | Random Effects Assessment of Site Effect on Modified Rankin Scale (mRS) <= 3 | The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All the non-missing mRS scores at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
|---|
| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Primary | Longitudinal Assessment of Participants With Modified Rankin Scale (mRS) <=3 | Comparing longitudinal modified Rankin Scale (mRS) scores 0-3 at Day 30 and Day 180. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All the non-missing mRS scores at 30 days and 180 days were analyzed. | Posted | | Number | | Percentage of participants | | 30 days and 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | All Cause Mortality | | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Clot Removal (Amount of Residual Blood) | Change in blood volume measured between stability scan and end of treatment scan | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | odds ratio per time-weighted ml | | 72 hours | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - Hospital Days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Median | Inter-Quartile Range | Number of days | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - ICU Days | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Median | Inter-Quartile Range | Number of days | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - ICP Management | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | Percentage of events of ICP >20mmHg | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - Mechanical Ventilation | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with ventilation | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - Pressors | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with pressors | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - Shunts | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with shunts | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - All Infections | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with infections | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - Pneumonia | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with pneumonia | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Intensity of Critical Care Management - All Infections | Intensity of critical care management as measured by hospital and ICU length of stay, frequency of ICP >20 mmHg events, use of mechanical ventilation, pressors, and ventriculoperitioneal shunts, frequency of systemic infections. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with infections | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Safety/Mortality - Mortality Within 30 Days | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | Percentage of patients | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Safety/Mortality - Bacterial Brain Infections Within 30 Days | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with brain infection | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Safety/Mortality - Systematic Bleeds Within 72 Hours | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with systematic bleeds | | 72 hours | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Safety/Mortality - Systematic Bleeds Within 30 Days | Frequency of bacterial brain infections, symptomatic brain bleeds, and mortality. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | % of participants with systematic bleeds | | 30 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Adverse and Serious Adverse Events | Assessment of number of adverse and serious adverse events by treatment group. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Predicting Hazards of Death by Treatment Group | Cox Proportional Hazards Model is used to predict the hazards ratio by treatment group. | All patients that were enrolled in CLEAR III were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (African-American) | Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients that reported they were African-American with a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | Percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Race (White) | Assessment of modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients that reported they were White with a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Female) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All female patients with a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Gender (Male) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All male patients with a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (65 Years or Under) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients 65 years of age or under with a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | Percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Age (Over 65 Years) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients over 65 years of age with a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | Percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Less Than 20ml) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients with an IVH size less than 20ml and a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (20-50ml) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients with an IVH size between 20ml and 50ml and a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by IVH Size (Greater Than 50ml) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients with an IVH size greater than 50ml and a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Thalamic) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients with a thalamic blood clot location and a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Sub-Group Analyses - Difference in Modified Rankin Scale (mRS) 0-3 Proportion by Location (Non-Thalamic) | Assessment of Modified Rankin Scale (mRS) score 0-3 compared by race, gender, age, IVH size, and ICH location. The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from 0 (perfect health without symptoms) to 6 (death). | All patients with a non-thalamic blood clot location and a non-missing mRS score at 180 days were analyzed. | Posted | | Number | | percentage of participants | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Functional Status - Barthel Index | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence. | All the non-missing Barthel scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | Barthel score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Functional Status - Participants With Extended Glasgow Outcome (eGOS) Score >=Upper Severe Disability | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery. | All the non-missing eGOS scores at 180 days were analyzed. | Posted | | Number | | % of participants with score>=4 | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Functional Status - National Institutes of Health Stroke Scale (NIHSS) | Assessment of NIHSS, Barthel Index, eGOS (dichotomy and ordinal) by group. The National Institutes of Health Stroke Scale (NIHSS) is a 15-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke). | All the non-missing NIHSS scores at 180 days were analyzed. | Posted | | Median | Inter-Quartile Range | NIHSS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Strength | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Mobility | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Hand Function | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Activities of Daily Living | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Communication | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Thinking | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Emotion | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Participation | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - Stroke Impact Scale (SIS) - Recovery | Assessment of SIS and EuroQol Visual Analog Scale by group. The Stroke Impact Scale (SIS) covers 8 dimensions of stroke outcomes: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory and thinking, participation. It is scored on a scale of 0 to 100 for each dimension, with higher scores indicating better self-reported health. | All the non-missing SIS scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | SIS score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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| Secondary | Quality of Life - EuroQol Visual Analogue Scale (EQ-VAS) | Assessment of SIS and EuroQol Visual Analog Scale by group. EuroQol Visual Analogue Scale (EQ-VAS) is a self-reported measure of health status. It is a marked scale where individuals draw a line to indicate their health, with end points of 0 (the worst health you can imagine) and 100 (the best health you can imagine). | All the non-missing EuroQol scores at 180 days were analyzed. | Posted | | Mean | Standard Deviation | EuroQol score | | 180 days | | | | ID | Title | Description |
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| OG000 | Alteplase | Administration of alteplase via the intraventricular catheter Alteplase: 1.0 mg of alteplase will be administered via the intraventricular catheter every 8 hours for up to 12 doses | | OG001 | Saline Placebo | 1 ml of normal saline administered via the intraventricular catheter Normal saline: 1 ml of normal saline will be administered via the intraventricular catheter every 8 hours for up to 12 doses |
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