FFP Versus PCC in Intracranial Hemorrhage

• Status: Withdrawn
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Thrombin

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