FFP Versus PCC in Intracranial Hemorrhage
Intracranial Hemorrhage, Traumatic, Intracranial Hemorrhage, Spontaneous
About this trial
This is an interventional treatment trial for Intracranial Hemorrhage, Traumatic focused on measuring Warfarin, Traumatic intracranial hemorrhage, prothrombin complex concentrate, fresh frozen plasma, Spontaneous intracranial hemorrhage
Eligibility Criteria
Inclusion Criteria:
- Coumadin use
- INR of 2.0 or higher on arrival at the study center
- Evidence on cranial imaging of spontaneous intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, traumatic subarachnoid hemorrhage, or traumatic intraparenchymal hemorrhage
Exclusion Criteria:
- Unable to obtain consent
- Estimated survival <24 hours
- Hypersensitivity to 4 factor prothrombin complex concentrate
- Concomitant use of novel vitamin K antagonists
- Religious/social prohibition to receiving blood products
- Need for emergent, non-neurosurgical operative intervention
- Mechanical heart valves
Sites / Locations
- University of Utah Medical Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Fresh Frozen Plasma
Four Factor Prothrombin Complex Concentrate
Administration of a single dose of fresh frozen plasma based on INR per the following regimen: 2U for INR of 2-2.5; 3U for INR of 2.5-3; 4U for INR of 3-3.5; 5U for INR of 3.5-4; 6U for INR of 4+
Administration of a single dose of four factor prothrombin complex concentrate per the following dosing regimen: 25 U/kg for INR of 2-4; 35 U/kg for INR of 4-6; 50 U/kg for INR of 6+; maximum dosing weight of 100kg, patients may be dispensed +/- 10% of ordered dose