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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%).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prothrombin Complex Concentrate | Experimental | Administration of a single dose of prothrombin complex concentrate (25 U/kg equivalent factor IX) |
|
| Fresh Frozen Plasma | Active Comparator | Administration of a single dose of fresh frozen plasma of 15 mL/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prothrombin Complex Concentrate | Drug | Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S |
|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Lille | Lille | 59037 | France | |||
| CHU de NANCY |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37870112 | Derived | Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5. |
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| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005164 | Factor IX |
| ID | Term |
|---|---|
| D004792 | Enzyme Precursors |
| D045762 | Enzymes and Coenzymes |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
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| Fresh Frozen Plasma | Biological | Pooled collection of plasma from donors |
|
| Nancy |
| 54000 |
| France |
| Fondation Ophtalmologique Adolphe de Rothschild (FOR) | Paris | 75019 | France |
| Hôpital Foch | Suresnes | 92150 | France |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011506 |
| Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |