Intracranial Hemorrhage, Traumatic Clinical Trial
Official title:
Fresh Frozen Plasma Versus Four Factor Prothrombin Complex Concentrate for Reversal of Vitamin K Antagonists in Intracranial Hemorrhage
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05364749 -
Selective CT for Anticoagulated Head Injured Patients
|
||
| Completed |
NCT02996851 -
Traumatic Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
|
N/A |