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%).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
Pooled collection of plasma from donors
CHU de Lille
Lille, France
CHU de NANCY
Nancy, France
Fondation Ophtalmologique Adolphe de Rothschild (FOR)
Paris, France
Hôpital Foch
Suresnes, France
Proportion of patients with correction of prothrombin time (PT more than 60%)
Time frame: End of treatment administration (an average of 1 hour)
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