| Primary | 24-hour Mortality | | Number of subjects who were randomized to each group | Posted | | Number | | participants | | First 24 hours after ED admission | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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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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| Initial sample size (580) planned to detect a clinically meaningful 10% difference in 24-hour mortality (11% vs. 21%) supported by prior data. Data Safety Monitoring Board (DSMB) increased sample size to 680 according to trial's adaptive design. With 680 pts. & given the final observed mortality proportions in 1:1:1 group, PROPPR had 95% power to detect the pre-specified 10% difference at 24 hours if such differences existed. | Mantel Haenszel | The critical level for significance (p<0.044) was adjusted for two interim analyses, and all tests were conducted using two-sided tests. | 0.12 | | Adjusted Relative Risk | 0.75 | | | 2-Sided | 95 | 0.52 | 1.08 | | | | | |
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| Primary | 30-day Mortality | | Number of subjects enrolled into each group. | Posted | | Number | | participants | | First 30 days after ED admission | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Primary | Coagulation as Indicated by Number of Participants With Reported Venous Thrombolic Events (VTE) | Blood samples were collected at time of ED admission and over time to determine the incidence of reported venous thrombolic events (VTE). | Number of subjects who were randomized to each group | Posted | | Number | | participants | | From time of ED admission, for up to 72 hours | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio. |
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| Secondary | Hospital Free Days | | Number of hospital free days for each group. | Posted | | Median | Inter-Quartile Range | days | | first 30 days after ED admission | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Time to Hemostasis | Time to hemostasis refers to the time that the subject achieved hemorrhage control (anatomic hemostasis and resuscitation complete)following emergency department (ED) arrival. | Time to anatomic hemostasis | Posted | | Median | Inter-Quartile Range | minutes | | ED admission to hospital discharge or 30 days, whichever comes first | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Amount of Randomized Blood Products Given to Hemostasis | | | Posted | | Median | Inter-Quartile Range | units of blood products | | 24 hours from randomization | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Functional Status at Time of Hospital Discharge | The Glasgow Outcome Extended Score (GOSE) is a tool used to measure recovery following brain injury and assists with prediction of long-term rehabilitation. The 8 scoring categories are death, vegetative state, lower severe disability, upper severe disability, lower moderate disability, upper moderate disability, lower good recovery and upper good recovery. A higher GOSE score correlates with better outcome. | Glasgow Outcome Extended Score (GOSE) Score on discharged patients who had a head injury (Abbreviated Injury Score (AIS) > 1) ranging from 1 to 8. The AIS is a coding scale to classify the injury severity. A score is created for each body region, type of anatomic structure (i.e. whole area, vessels,organs), and severity(minor to maximum). | Posted | | Median | Inter-Quartile Range | units on the GOSE scale | | Hospital discharge or 30 days, whichever comes first | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Incidence of Primary Surgical Procedure | | Incidence of primary surgical procedure | Posted | | Number | | participants | | ED admission to hospital discharge or 30 days, whichever comes first | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Incidence of Transfusion Related Serious Adverse Events | | Incidence of transfusion related serious adverse events-Reportable to FDA | Posted | | Number | | participants | | ED admission to hospital discharge or 30 days, whichever comes first | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Initial Hospital Discharge Status | | Disposition of subject at time of hospital discharge | Posted | | Number | | participants | | Hospital discharge or 30 days, whichever comes first | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Ventilator Free Days | | Number of ventilator free days for each group. | Posted | | Median | Inter-Quartile Range | days | | first 30 days after ED admission | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | ICU Free Days | | Number of ICU free days for each group. | Posted | | Median | Inter-Quartile Range | days | | first 30 days after ED admission | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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| Secondary | Amount of Blood Products Given From Hemostasis to 24 Hours After ED Admission | | Unit of measure for outcome measures below is median number of blood product units that given in each group (1:1:1 or 1:1:2) from time initial hemostasis was complete (PROPPR randomized study products stopped) up to 24 hours following ED admission. Number of participants is based on those who survived up to 24 hours, not participants randomized. | Posted | | Median | Inter-Quartile Range | units of blood products | | 24 hours after ED admission | | | | ID | Title | Description |
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| OG000 | 1:1:1 Blood Transfusion Ratio | 1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol. | | OG001 | 1:1:2 Blood Transfusion Ratio | 1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol. |
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