FFP Versus PCC in Intracranial Hemorrhage

Withdrawn before enrolling · Not applicable

Conditions studied: Intracranial Hemorrhage, Traumatic, Intracranial Hemorrhage, Spontaneous

In brief

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.

Key facts

Study ID

NCT02429453

Run by

University of Utah

People needed

0

Starts

2015-04-01

Expected to finish

2016-03-01

Last updated by the study team

2016-11-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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