MedTrace Logo

FFP Versus PCC in Intracranial Hemorrhage

NCT02429453 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2016-11-16

No results posted yet for this study

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.

Conditions

  • Intracranial Hemorrhage, Traumatic
  • Intracranial Hemorrhage, Spontaneous

Interventions

DRUG

Four Factor Prothrombin Complex Concentrate

A purified, non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S

BIOLOGICAL

Fresh Frozen Plasma

A pooled collection of plasma from donors

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02429453 on ClinicalTrials.gov