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Clinical trial

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

ID
Name
AGR_2014-22
Description
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%).
Trial arms
Trial start
2016-01-21
Estimated PCD
2019-03-27
Trial end
2019-03-27
Status
Completed
Phase
Early phase I
Treatment
Prothrombin Complex Concentrate
Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C \& S
Arms:
Prothrombin Complex Concentrate
Fresh Frozen Plasma
Pooled collection of plasma from donors
Arms:
Fresh Frozen Plasma
Size
18
Primary endpoint
Proportion of patients with correction of prothrombin time (PT more than 60%)
End of treatment administration (an average of 1 hour)
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}
Updated at
2024-06-05

1 organization

2 products

1 indication

Organization
Fondation Ophtalmologique Adolphe de Rothschild
Product
Prothrombin Complex Concentrate
Indication
Intracranial Hemorrhage
Product
Fresh Frozen Plasma