The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.
Vitamin K antagonists in general and Coumadin in particular remains the most common form of outpatient anticoagulation in patients today. Despite the therapeutic benefits of these agents, bleeding in general and intracranial bleeding in particular are significant risks associated with these medications. Intracranial bleeding on oral anticoagulation agents are associated with a 20% increase in 30 day mortality versus non-anticoagulated controls, and rapid reversal of vitamin K antagonists in this population has been shown to have survival benefits. Historically, vitamin K antagonists have been reversed using fresh frozen plasma (FFP) transfusions which, though effective, often incur delays due to the time required to obtain a type \& screen, thaw the product, and administer the product to the patient. In 2013, the FDA approved 4-factor prothrombin complex (PCC), a concentrate of factors II, VII, IX, X, protein C and protein S for use as a method for correcting vitamin K antagonist related coagulopathy. Though large, prospective randomized control trials have demonstrated efficacy and safety in a general population of all-comers bleeding, there is very little literature regarding the benefits of PCC versus FFP in the traumatic and spontaneous intracranial hemorrhage population. Current standard of care in patients with traumatic and spontaneous intracranial hemorrhage who are on vitamin K antagonists is to reverse the effect of these agents with FFP or PCC. The choice of which agent to use is currently determined by both availability of each agent and surgeon preference. For this study, there will be an equal likelihood of either treatment being given. The goal of this study will be to determine whether PCC confers any benefits over FFP in traumatic and spontaneous intracranial hemorrhage with respect to multiple factors including time to correction, absolute international normalized ratio correction amount, cost, need for surgical intervention, and radiographic bleed expansion through a prospective, randomized control trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
A purified, non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
A pooled collection of plasma from donors
University of Utah Medical Center
Salt Lake City, Utah, United States
Rapid reversal of warfarin as measured by international normalized ratio (INR) drawn at 30 minutes after transfusion
INR level 30 minutes after transfusion completion of FFP or 4 factor prothrombin complex concentrate
Time frame: 30 minutes after transfusion completion
Radiographic expansion of traumatic intracerebral hemorrhage as measured by CT scan within 24 hours of presentation
Expansion of blood on repeat CT scan of \>10%
Time frame: 24 hours after presentation
Timing of reversal of warfarin as measured by INR drawn at 3 hours, 8 hours and 24 hours after transfusion
INR level at 3 hours, 8 hours and 24 hours after transfusion completion of FFP or prothrombin complex concentrate
Time frame: 3-24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion
Thromboelastography response as measured by results of ROTEM analysis at 30 minutes and 24 hours after transfusion
Results of ROTEM analysis at 30 minutes and 24 hours after transfusion
Time frame: 30 minutes and 24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion
Absolute INR reversal as measured by INR drawn 24 hours after transfusion
Difference between initial INR and INR 24 hours after completion of transfusion
Time frame: 24 hours after completion of FFP or 4 factor prothrombin complex concentrate transfusion
Need for operative intervention as measured by need for neurosurgical procedure during the hospitalization
Need for operative intervention during hospitalization related to initial trauma
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Time frame: During duration of hospital stay, an expected average of 1 week
Estimated blood loss during any neurosurgical procedure
Estimated blood loss during any neurosurgical interventions during the hospitalization
Time frame: During duration of hospital stay, an expected average of 1 week
Further transfusion needs as measured by number of units of blood/platelet/plasma products transfused during the hospitalization
Need for blood product transfusions during hospitalization
Time frame: During duration of hospital stay, an expected average of 1 week
In hospital mortality
Mortality during hospital stay
Time frame: During duration of hospital stay, an expected average of 1 week
Total hospital cost
Total cost of hospital stay based on hospital charges
Time frame: During duration of hospital stay, an expected average of 1 week
30 day outcome as measured by the Glasgow outcome score
Glasgow outcome score 30 days after discharge
Time frame: 30 days after discharge
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
Development of deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, unanticipated intubation, heart failure, or need for aggressive diuresis
Time frame: During duration of hospital stay, an expected average of 1 week