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This study is a non-randomized, Phase 2 clinical trial designed to assess optical cerebral blood flow (CBF) response to bolus normal saline. Subjects will have had an ischemic stroke within 96 hours of enrollment. The study intervention will be a one hour monitoring session. There will be a 15 minute baseline measurement period, followed by intravenous administration of 500cc of 0.9% NaCl over 30 minutes, and finally 15 minutes of monitoring post-bolus. All study measurements will cease after 1 hour. Subjects will be followed during their hospitalization for 7 days or until discharge, whichever is sooner, to monitor for adverse events and to collect clinical information.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Experimental | intravenous administration of 500cc of 0.9% NaCl over 30 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Normal saline | Other | intravenous administration of 500cc of 0.9% NaCl over 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | Ipsilesional hemisphere | 30 minutes after completion of saline bolus |
| The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | contralesional hemisphere | 30 minutes after completion of saline bolus |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Saline | intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
81 subjects enrolled. A technical advancement in DCS fiber optic probe design increased signal-to-noise ratio occurred after the first 8 subjects; these subjects were excluded because their data was not comparable to later subjects. 5 subjects who failed to complete the monitoring session and 11 subjects were excluded due to poor data quality.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Saline | intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | Ipsilesional hemisphere | Posted | Median | Inter-Quartile Range | percent change from baseline flow | 30 minutes after completion of saline bolus |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Saline | intravenous administration of 500cc of 0.9% NaCl over 30 minutes Normal saline: intravenous administration of 500cc of 0.9% NaCl over 30 minutes |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IV infiltration | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Mullen | University of Pennsylvania | 215-662-3339 | mmullen@pennmedicine.upenn.edu |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Time from symptom onset | Median | Inter-Quartile Range | hours |
|
| NIH Stroke Scale | The National Institutes of Health Stroke Scale (NIHSS) is a measure of stroke severity, ranging from 0-42, with 0 representing no neurologic deficit and 42 representing severe neurologic impairment. | Median | Inter-Quartile Range | units on a scale |
|
|
| Primary | The Percentage of Change in Optical Cerebral Blood Flow (oCBF) During Bolus Normal Saline Compared to Baseline, as Measured by Diffuse Correlation Spectroscopy (DCS). | contralesional hemisphere | Posted | Median | Inter-Quartile Range | percent change from baseline flow | 30 minutes after completion of saline bolus |
|
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 3 |
| 81 |
| Elevated systolic blood pressure | Cardiac disorders | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment | Subject was in atrial fibrillation at start of monitoring session, developed tachycardia during monitoring due to rapid ventricular response |
|
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| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Slope |
| 0.05 |
| 2-Sided |
| 95 |
| 0.03 |
| 0.07 |
| Superiority |
Mixed effects regression, modeling the interaction term for time x normal saline bolus in the ipsilesional hemisphere |