Intracranial Hemorrhages
Conditions
Brief summary
This prospective, randomized, multicenter study is performed to determine whether prothrombin complex concentrates confers any benefits over fresh frozen plasma in adult neurological patients with coagulation disorders (PT value less than 60%).
Detailed 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 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.
Interventions
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S
BIOLOGICALFresh Frozen Plasma
Pooled collection of plasma from donors
Sponsors
Fondation Ophtalmologique Adolphe de Rothschild
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient with spontaneous intracranial hemorrhage or traumatic intracranial hemorrhage or patient requiring neurological surgery * Coagulation disorder defined by PT less than 60%
Exclusion criteria
* Concomitant use with oral anticoagulant drugs * Acquired deficiency of coagulation factors whose treatment is established * Hypersensitivity to a PCC * History of thrombocytopenia induced by heparin * Disseminated intravascular coagulation * Extracranial active bleeding * Hypersensitivity to vitamin K
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with correction of prothrombin time (PT more than 60%) | End of treatment administration (an average of 1 hour) |
Countries
France
Outcome results
None listed