Intracranial haemorrhage (intracerebral and acute subdural haematoma) Circulatory System Intracerebral haemorrhage
Conditions
Interventions
Octaplex® intravenous administration at the inclusion, 25 IU/kg or 40 IU/kg according to the randomisation. In addition, administration of 5 mg vitamin K, intravenous infusion for all the patients.
Sponsors
Octapharma AG (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of 18 years of age or older, either sex 2. Intracranial haemorrhage (intracerebral and acute subdural) confirmed by medical imaging (computed tomography only) 3. Use of oral anticoagulant, only vitamin K antagonist 4. Written informed consent from the patient or a legally acceptable representative if the subject is unable to provide informed consent, or from the investigator and an independent witness from the investigator and the sponsor, if no legally acceptable representative is available at inclusion
Exclusion criteria
Exclusion criteria: 1. Deep coma on admission (score 3 to 5 on the Glasgow Coma Scale) because their probability of survival is close to zero 2. Septic shock or severe sepsis in the past fourteen days prior to inclusion 3. Crush injury in the past seven days prior to inclusion 4. Known or suspected disseminated intravascular coagulation 5. Pulmonary embolism or phlebitis in the last 3 months prior to inclusion 6. Patients receiving vitamin K prior to admission to investigational centre 7. Known allergy to vitamin K or to any of its excipients 8. Hypersensitivity to the active substances of Octaplex® (human coagulation factors II, VII, IX and X) or to any of its excipients (heparin and sodium citrate) 9. Known allergy to heparin or history of heparin-induced thrombocytopenia 10. Participation in another clinical study, currently or during the past three months 11. Pregnant or lactating women 12. Jehovah's witnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| INR at 10 ± 5 minutes after the end of injection in patients with intracranial haemorrhage related to oral anticoagulant therapy, measured by local laboratories (standard method). | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1. Laboratory parameters (coagulation): INR, prothrombin time (PT), thrombin generation assay (TGA), coagulation factors II, VII, IX and X, protein C and protein S at 10 ± 5 minutes, 1, 3, 6 and 24 hours after the end of injection. All these parameters will be analysed by local or central laboratory using standard methods. 2. Medical imaging (CT scan): volume of haematoma at 48 hours after the end of injection (or earlier in case of neurological worsening assessed by National Institutes of Health [NIH] Stroke Scale); the computed tomography images at T0 and T48 hours will be analysed by the central neuroradiology centre with the software OSIRIX 3. Clinical status: Glasgow Coma Scale (score: 3 - 15) and NIH Stroke Scale at 1, 24 and 48 hours, and on days 3 and 30 (or earlier if patient discharged) after the end of injection 4. Global outcome: 4.1. Survival (is the patient dead? Yes or No) 4.2. Extended Glasgow Outcome Scale (GOS) (score: 1 - 8, 1 = dead, 8 = upper good recovery) 4.3. Modified Rankin Scale (MRS) (score: 0 - 6, 0 = no symtoms at all, 6 = dead) 4.4. Barthel Index (score: 0 - 100, 100 = patient is continent, feeds himself, dresses himself, gets up out of bed and chairs, bathes himself, walks at least a block, and can ascend and descend stairs) All measured on day 30 (or earlier if patient discharged) after the end of injection. 5. Overall clinical response: this assessment will be done by the investigator using a verbal rating scale: 5.1. None: in spite of sufficient treatment uncontrolled intracranial bleeding growth requiring additional measures 5.2. Moderate: in spite of sufficient treatment uncontrolled intracranial bleeding and haematoma growth; no additional measures required 5.3. Excellent: intracranial bleeding and haematoma growth under control, comparable to a normal patient Measured 48 hours after the end of injection. Safety: 6. Study drug actually received 7. Adverse events (AEs) during the whole stay in all patients. AEs will be | — |
Countries
France
Outcome results
None listed