NCT02777424

CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Intracranial Hemorrhages

Interventions

Type	Name	Description
DRUG	Prothrombin Complex Concentrate	Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
BIOLOGICAL	Fresh Frozen Plasma	Pooled collection of plasma from donors

Timeline

• Start date: 2016-01-21
• Primary completion: 2019-03-27
• Completion: 2019-03-27
• First posted: 2016-05-19
• Last updated: 2024-06-05

Locations

4 sites across 1 country: France