WithdrawnNot Applicable

FFP Versus PCC in Intracranial Hemorrhage

Stopped: Lack of enrolment

United States0Started 2015-04

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Rapid reversal of warfarin as measured by international normalized ratio (INR) drawn at 30 minutes after transfusion

Timeframe: 30 minutes after transfusion completion

Trial details

NCT IDNCT02429453

SponsorUniversity of Utah

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Intracranial Hemorrhage, Traumatic trials