CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients (CLOT-CRANE)

Fondation Ophtalmologique Adolphe de Rothschild

Status and phase: Completed; Phase 4

Conditions: Intracranial Hemorrhages

Treatments: Biological: Fresh Frozen Plasma; Drug: Prothrombin Complex Concentrate

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT02777424

AGR_2014-22

Details and patient eligibility

About

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%).

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Prothrombin Complex Concentrate

Experimental group

Description:

Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX)

Treatment:

Drug: Prothrombin Complex Concentrate

Fresh Frozen Plasma

Active Comparator group

Description:

Administration of a single dose of fresh frozen plasma of 15 mL/kg

Treatment:

Biological: Fresh Frozen Plasma