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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

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, a legally acceptable representative (LAR), physician statement or in countries where waiver of consent is allowed, a completed waiver form. 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, acute septicaemia, acute crush injury, acute disseminated intravascular coagulation (DIC) or acute thrombotic stroke
10. Pregnancy
11. Known history of unstable angina or claudication within last 30 days, or any known history of myocardial infarction, ischaemic stroke, previous limb amputation due to vascular disease, deep vein thrombosis or pulmonary embolism
12. Known or suspected allergy to trial product or related products
13. Previous participation in this trial
14. Known participation in ANY investigational drug or device trial within 30 days of entry into this trial
15. Any other condition which, in the judgement of the Investigator, might increase the risk to the patient or preclude the satisfactory ability to collect experimental data

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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