Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Intracranial Hemorrhages
Type
Interventional
Phase
Phase 4
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. They are diagnosed more often in emergency on a PT value less than 60% and so they should be corrected as soon as possible. Two therapeutic strategies ar...

The coagulation disorders increase the risk of bleeding and are a risk factor of intracranial hemorrhagic complications in neurosurgical patients. They are diagnosed more often in emergency on a PT value less than 60% and so they should be corrected as soon as possible. Two therapeutic strategies are proposed by French or international recommendations: transfusion of fresh frozen plasma (FFP) or administration of prothrombin complex concentrates (PCC). This prospective, randomized, multicenter study with blinded assessment of the primary endpoint, is performed to determine whether PCC confers any benefits over FFP in the neurological patients with coagulation disorders.

Tracking Information

NCT #
NCT02777424
Collaborators
Not Provided
Investigators
Not Provided