CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

• Status: Recruiting
• Trial end date: 2022-07-27
• Target enrollment: 0
• Participant gender: All

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%).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Treatments: Thrombin

Criteria

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