CPP Versus PFC to Correct Coagulation Disorders in Adult Neurosurgical Patients

Study Overview
=================
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.

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

Conditions
-----------------
Intracranial Hemorrhages

Intervention / Treatment
-----------------
* Drug: Prothrombin Complex Concentrate
* Biological: Fresh Frozen Plasma


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prothrombin Complex Concentrate<br>Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX) | Drug: Prothrombin Complex Concentrate<br>* Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S<br>|
| Active Comparator: Fresh Frozen Plasma<br>Administration of a single dose of fresh frozen plasma of 15 mL/kg | Biological: Fresh Frozen Plasma<br>* Pooled collection of plasma from donors<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with correction of prothrombin time (PT more than 60%) |  | End of treatment administration (an average of 1 hour) |