Efficacy and safety of two dose regimens of Octaplex® in patients with intracranial haemorrhage related to oral anticoagulant therapy

Completed

• Conditions: Intracranial haemorrhage (intracerebral and acute subdural haematoma); Circulatory System; Intracerebral haemorrhage

• Registration Number: ISRCTN34868002
• Lead Sponsor: Octapharma AG (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified