Intracranial Hemorrhages Clinical Trial
— CLOT-CRANEOfficial title:
Prothrombin Complex Concentrate Versus Fresh Frozen Plasma to Correct Coagulation Disorders in Adult Neurosurgical Patients
Verified date | June 2024 |
Source | Fondation Ophtalmologique Adolphe de Rothschild |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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%).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Fondation Ophtalmologique Adolphe de Rothschild |
France,
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) |
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