CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

Intracranial Hemorrhages Clinical Trial

— CLOT-CRANE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02777424
• Other study ID #: AGR_2014-22
• Status: Completed
• Phase: Phase 4
• Start date: January 21, 2016
• Est. completion date: March 27, 2019

Study information

• Verified date: June 2024
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders
• Intracranial Hemorrhages

Intervention

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

Locations

Country	Name	City	State
France	CHU de Lille	Lille
France	CHU de NANCY	Nancy
France	Fondation Ophtalmologique Adolphe de Rothschild (FOR)	Paris
France	Hôpital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with correction of prothrombin time (PT more than 60%)		End of treatment administration (an average of 1 hour)