Randomised, Double-Blind, Placebo Controlled, Multi-Centre, Parallel Groups Confirmatory Efficacy and Safety Trial of Activated Recombinant Factor VII (NovoSeven®/Niastase®) in Acute Intracerebral Haemorrhage

• Conditions: MedDRA version: 7.1Level: LLTClassification code 10022753; Acute Intracerebral Haemorrhage

• Registration Number: EUCTR2004-004202-24-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-18
• Last Update Posted: 1 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 816

Inclusion Criteria

1. Spontaneous ICH (including bleeding in brainstem and cerebellum) diagnosed by CT scan within 3 hours of symptom onset
2. Male or female patients, aged =18 years (=20 in Taiwan)
3. Informed consent obtained before any trial related activities*.
If permitted by local legislation informed consent can be provided by next of kin/legally authorized representative (LAR). Consent must also be obtained by the patient as soon as he/she is able to do so
*Trial-related activities are any procedure that would not have been performed during normal management of the patient.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Time of symptom onset of ICH is unknown or more than 3 hours
2. Patients with secondary ICH related to infarction, tumour, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM), thrombolysis or severe trauma
3. Surgical haematoma evacuation planned within 24 hours of symptom onset
4. Deep coma (GCS 3-5) at the time of admission
5. Known oral anti-coagulant use (unless the INR is documented below 1.4); aspirin use is not an exclusion criterion
6. Known thrombocytopenia (unless current platelets documented above 50000/µL)
7. Pre-existing disability (i.e. must have a mRS score of 0-2 before stroke)
8. Any known history of haemophilia or other coagulopathy
9. Known acute myocardial ischemia, unresolved unstable angina, acute septicaemia, acute crush injury, acute disseminated intravascular coagulation (DIC) or acute thrombotic stroke
10. Pregnancy
11. Known or suspected allergy to trial product or related products
12. Previous participation in this trial
13. Known participation in ANY investigational drug or device trial within 30 days of entry into this trial
14. Patients known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified