drugset / Trial / NCT02429453

FFP Versus PCC in Intracranial Hemorrhage

NCT02429453 ↗

Withdrawn University of Utah
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-04
Primary completion
2016-03
Completion
2016-03

Outcome

Outcome not reported

Stopped: “Lack of enrolment”

Drugs

EvaluationDrugModalityDoseRoute
Subject Four Factor Prothrombin Complex Concentrate Protein / enzyme biologic 25 unknown —
Subject Four Factor Prothrombin Complex Concentrate Protein / enzyme biologic 35 unknown —
Subject Four Factor Prothrombin Complex Concentrate Protein / enzyme biologic 50 unknown —
Comparator Fresh Frozen Plasma Protein / enzyme biologic 2 unknown —
Comparator Fresh Frozen Plasma Protein / enzyme biologic 3 unknown —
Comparator Fresh Frozen Plasma Protein / enzyme biologic 4 unknown —
Comparator Fresh Frozen Plasma Protein / enzyme biologic 5 unknown —
Comparator Fresh Frozen Plasma Protein / enzyme biologic 6 unknown —