Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Rapid reversal of warfarin as measured by international normalized ratio (INR) drawn at 30 minutes after transfusion	30 minutes after transfusion completion	INR level 30 minutes after transfusion completion of FFP or 4 factor prothrombin complex concentrate
Secondary	Radiographic expansion of traumatic intracerebral hemorrhage as measured by CT scan within 24 hours of presentation	24 hours after presentation	Expansion of blood on repeat CT scan of \>10%
Secondary	Timing of reversal of warfarin as measured by INR drawn at 3 hours, 8 hours and 24 hours after transfusion	3-24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion	INR level at 3 hours, 8 hours and 24 hours after transfusion completion of FFP or prothrombin complex concentrate
Secondary	Thromboelastography response as measured by results of ROTEM analysis at 30 minutes and 24 hours after transfusion	30 minutes and 24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion	Results of ROTEM analysis at 30 minutes and 24 hours after transfusion
Secondary	Absolute INR reversal as measured by INR drawn 24 hours after transfusion	24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion	Difference between initial INR and INR 24 hours after completion of transfusion
Secondary	Need for operative intervention as measured by need for neurosurgical procedure during the hospitalization	During duration of hospital stay, an expected average of 1 week	Need for operative intervention during hospitalization related to initial trauma
Secondary	Estimated blood loss during any neurosurgical procedure	During duration of hospital stay, an expected average of 1 week	Estimated blood loss during any neurosurgical interventions during the hospitalization
Secondary	Further transfusion needs as measured by number of units of blood/platelet/plasma products transfused during the hospitalization	During duration of hospital stay, an expected average of 1 week	Need for blood product transfusions during hospitalization
Secondary	In hospital mortality	During duration of hospital stay, an expected average of 1 week	Mortality during hospital stay
Secondary	Total hospital cost	During duration of hospital stay, an expected average of 1 week	Total cost of hospital stay based on hospital charges
Secondary	30 day outcome as measured by the Glasgow outcome score	30 days after discharge	Glasgow outcome score 30 days after discharge
Secondary	Complications as measured by development of deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, unanticipated intubation, heart failure, or need for aggressive diuresis during the hospitalization	During duration of hospital stay, an expected average of 1 week	Development of deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, unanticipated intubation, heart failure, or need for aggressive diuresis

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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