Recombinant Factor VIIa for acute bleeding in the brain (Hemorrhagic Stroke) administered at earliest Time - (FASTEST) Trial

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Nervous System Diseases [C10]; Acute Hemorrhagic Stroke; MedDRA version: 21.1Level: LLTClassification code 10048863Term: Hemorrhagic strokeSystem Organ Class: 100000004852

• Registration Number: EUCTR2019-003722-25-GB
• Lead Sponsor: niversity of Cincinnati

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-09-28
• Last Update Posted: 5 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 860

Inclusion Criteria

1) Patients aged 18-80 years, inclusive
2) Patients with spontaneous ICH (intracerebral hemorrhage)
3) Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well
4) Efforts to obtain informed consent per EFIC (exception from Informed Consent) guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 258
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 602

Exclusion Criteria

1) Score of 3 to 7 on the Glasgow Coma Scale
2) Secondary ICH related to known causes (e.g., trauma, aneurysm, arteriovenous malformation (AVM), oral anticoagulant use (vitamin K antagonists or novel oral anticoagulants) within the past 7 days, coagulopathy, etc.)
3) ICH volume < 2 cc and = 60 cc
4) IVH (intraventricular hemorrhage) score > 7
5) Pre-existing disability (mRS > 2)
6) Symptomatic thrombo-embolic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
7) Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
8) Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
9) Refusal to participate in study by patient, legal representative, or family member
10) Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/µL)
11) Unfractionated heparin use with abnormal PTT
12) Low-molecular weight heparin use within the previous 24 hours
13) Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
14) Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
15) Recent (within 30 days) participation in any investigational drug or device trial or earlier participation in any investigational drug or device trial for which the duration of effect is expected to persist until to the time of FASTEST enrollment
16) Planned withdrawal of care or comfort care measures
17) Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism,drug dependency, or psychological disorder)
18) Known or suspected allergy to trial medication(s), excipients, or related products
19) Contraindications to study medication
20) Previous participation in this trial (previously randomized)
21) Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment

Study & Design

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