CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

Phase 4

Completed

• Conditions: Intracranial Hemorrhages
• Interventions: Biological: Fresh Frozen Plasma; Drug: Prothrombin Complex Concentrate

• Registration Number: NCT02777424
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

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.

Study Timeline

• Study Start: 2016-01-21
• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Primary Completion: 2019-03-27
• Study Completion: 2019-03-27
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fresh Frozen Plasma	Fresh Frozen Plasma	Administration of a single dose of fresh frozen plasma of 15 mL/kg
Prothrombin Complex Concentrate	Prothrombin Complex Concentrate	Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)

Primary Outcome Measures

Name	Time	Method
Proportion of patients with correction of prothrombin time (PT more than 60%)	End of treatment administration (an average of 1 hour)

Trial Locations

Locations (4)

CHU de Lille; 🇫🇷 Lille, France

Fondation Ophtalmologique Adolphe de Rothschild (FOR); 🇫🇷 Paris, France

CHU de NANCY; 🇫🇷 Nancy, France

Hôpital Foch; 🇫🇷 Suresnes, France