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Clinical Trial 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%).


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02777424
Study type Interventional
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact
Status Completed
Phase Phase 4
Start date January 21, 2016
Completion date March 27, 2019

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