Actively Recruiting
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
Led by Joseph Broderick, MD · Updated on 2026-04-22
350
Participants Needed
89
Research Sites
212 weeks
Total Duration
On this page
Sponsors
J
Joseph Broderick, MD
Lead Sponsor
N
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of the rFVIIa for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial is to establish the first treatment for acute spontaneous intracerebral hemorrhage (ICH) within a time window and subgroup of patients that is most likely to benefit. The central hypothesis is that rFVIIa, administered within 120 minutes from stroke onset with an identified subgroup of patients most likely to benefit, will improve outcomes at 90 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy. FASTEST Part 2 is an extension of the FASTEST Trial where the subgroups include those treated within 2 hours with a positive spot sign on a baseline CT angiogram or patients treated within 90 minutes of stroke onset, with or without a positive spot sign.
CONDITIONS
Official Title
Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial - Part 2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 years
- Patients with spontaneous intracerebral hemorrhage (ICH)
- Able to receive study medication within 120 minutes of stroke onset with a positive spot sign on CT angiography, or within 90 minutes of stroke onset regardless of spot sign
- Informed consent obtained according to emergency research regulations including exception from informed consent (EFIC) where applicable
You will not qualify if you...
- Glasgow Coma Scale score between 3 and 7
- Secondary ICH due to trauma, aneurysm, arteriovenous malformation, or recent use of oral anticoagulants within 7 days
- Intracerebral hemorrhage volume less than 2 cc or 60 cc or more
- Blood filling two-thirds or more of one lateral ventricle or at least one-third of both lateral ventricles
- Pre-existing disability with Modified Rankin Scale greater than 2
- Symptomatic thrombotic or vaso-occlusive disease in past 90 days
- Evidence of acute myocardial ischemia on clinical or EKG evaluation
- Brainstem hemorrhage location (cerebellar hemorrhage allowed)
- Refusal to participate by patient or representative
- Known or suspected low platelet count below 50,000/µL
- Use of unfractionated heparin with abnormal PTT
- Use of pro-coagulant drugs within 24 hours before enrollment
- Use of low-molecular weight heparin within 24 hours before enrollment
- Recent carotid endarterectomy or vascular angioplasty or stenting within 90 days
- Advanced or terminal illness posing significant risk
- Recent participation in other investigational drug or device trials within 30 days or residual effects from prior trials
- Planned withdrawal of care or comfort measures
- Inability to comply with trial protocol due to substance abuse or psychological disorder
- Known or suspected allergy to study medication or related products
- Contraindications to study medication
- Previous participation in this trial
- Females of childbearing potential who are pregnant, within 12 weeks postpartum, or lactating at enrollment
AI-Screening
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Trial Site Locations
Total: 89 locations
1
University of Alabama Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Kaiser Permanente Baldwin Park Medical Center
Baldwin Park, California, United States, 91706
Actively Recruiting
3
Mills Peninsula Medical Center
Burlingame, California, United States, 94010
Actively Recruiting
4
Kaiser Permanente Downey Medical Center
Downey, California, United States, 90242
Actively Recruiting
5
Kaiser Permanente Fontana Medical Center
Fontana, California, United States, 92335
Actively Recruiting
6
Kaiser Permanente South Bay Medical Center
Harbor City, California, United States, 90710
Actively Recruiting
7
UCSD Health La Jolla
La Jolla, California, United States, 92037
Actively Recruiting
8
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Actively Recruiting
9
Kaiser Permanente West Los Angeles Medical Center
Los Angeles, California, United States, 90034
Actively Recruiting
10
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
11
UC Irvine Medical Center,
Orange, California, United States, 92868
Actively Recruiting
12
Kaiser Permanente Riverside Medical Center
Riverside, California, United States, 92505
Actively Recruiting
13
UC Davis Medical Center
Sacramento, California, United States, 95817
Actively Recruiting
14
UCSD Medical Center - Hillcrest Hospital
San Diego, California, United States, 92103
Actively Recruiting
15
San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
16
UF Health Shands Hospital
Gainesville, Florida, United States, 32608
Actively Recruiting
17
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
18
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Actively Recruiting
19
WellStar Kennestone Hospital
Marietta, Georgia, United States, 30060
Actively Recruiting
20
The Queen's Medical Center
Honolulu, Hawaii, United States, 96813
Actively Recruiting
21
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
22
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
23
Central DuPage Hospital
Winfield, Illinois, United States, 60190
Actively Recruiting
24
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
25
UMass Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
26
Henry Ford Hospital
Detroit, Michigan, United States, 48208
Actively Recruiting
27
M Health Fairview Ridges Hospital,
Burnsville, Minnesota, United States, 55337
Actively Recruiting
28
M Health Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
29
M Health Fairview St. John's Hospital
Maplewood, Minnesota, United States, 55109
Actively Recruiting
30
M Health Fairview University of Minnesota Medical Center Hospital,
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
31
Mayo Clinic Saint Marys Campus
Rochester, Minnesota, United States, 55902
Actively Recruiting
32
Barnes Jewish Hospital
St Louis, Missouri, United States, 63110
Actively Recruiting
33
North Shore University Hospital
Manhasset, New York, United States, 11030
Actively Recruiting
34
Mount Sinai West
New York, New York, United States, 10019
Actively Recruiting
35
The Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
36
Stony Brook University Hospital
Stony Brook, New York, United States, 11794
Actively Recruiting
37
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
38
OSU Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
39
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Actively Recruiting
40
St. John Medical Center
Tulsa, Oklahoma, United States, 74104
Actively Recruiting
41
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
Actively Recruiting
42
Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
43
Medical University of South Carolina University Hospital
Charleston, South Carolina, United States, 29425
Actively Recruiting
44
Prisma Health Greenville Memorial Hospital
Greenville, South Carolina, United States, 29605
Actively Recruiting
45
Memorial Hermann Memorial City Medical Center
Houston, Texas, United States, 77024
Actively Recruiting
46
Memorial Hermann-Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
47
University of Utah Healthcare
Salt Lake City, Utah, United States, 84132
Actively Recruiting
48
VCU Medical Center
Richmond, Virginia, United States, 23219
Actively Recruiting
49
University of Calgary - Foothills Medical Centre
Calgary, Alberta, Canada
Actively Recruiting
50
University of Alberta Hospital
Edmonton, Alberta, Canada, AB T6G 2B7
Actively Recruiting
51
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Actively Recruiting
52
Health Sciences Centre Winnipeg
Winnipeg, Manitoba, Canada, R3A 1R9
Actively Recruiting
53
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2
Actively Recruiting
54
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
55
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
56
St. Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Actively Recruiting
57
University of Montreal Hospital
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
58
University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, Germany, 69120
Actively Recruiting
59
University Hospital Erlangen
Erlangen, Bavaria, Germany, 91054
Actively Recruiting
60
Clinic Frankfurt Hoechst
Frankfurt am Main, Hesse, Germany
Actively Recruiting
61
University Hospital Augsburg
Augsburg, Germany, 86156
Actively Recruiting
62
Charite University Medicine Berlin
Berlin, Germany
Actively Recruiting
63
University Medical Center Hamburg
Hamburg, Germany, 20246
Actively Recruiting
64
University Hospital Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
65
National Cerebral and Cardiovascular Center
Suita, Osaka, Japan, 564-8565
Actively Recruiting
66
Kyushu Medical Center
Fukuoka, Japan
Actively Recruiting
67
Gifu University Hospital
Gifu, Japan
Actively Recruiting
68
Kagoshima City Hospital
Kagoshima, Japan
Actively Recruiting
69
Kobe City Medical Center General Hospital
Kobe, Japan
Actively Recruiting
70
Japanese Red Cross Kyoto Daini Hospital
Kyoto, Japan
Actively Recruiting
71
Iwate Prefectural Central Hospital
Morioka, Japan
Actively Recruiting
72
Niigata City General Hospital
Niigata, Japan
Actively Recruiting
73
KMU University Hospital
Osaka, Japan
Actively Recruiting
74
NHO Osaka National Hospital
Osaka, Japan
Actively Recruiting
75
Nakamura Memorial Hospital
Sapporo, Japan
Actively Recruiting
76
Jichi Medical University Hospital
Shimotsuke, Japan
Actively Recruiting
77
Kyorin University Hospital
Tokyo, Japan
Actively Recruiting
78
Toranomon Hospital
Tokyo, Japan
Actively Recruiting
79
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 21A 08916
Actively Recruiting
80
Vall d'Hebron University Hospital (VHUH)
Horta, Barcelona, Spain
Actively Recruiting
81
Bellvitge University Hospital,
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
82
Santa Creu and Sant Pau Hospital
Barcelona, Catalonia, Spain, 08025
Actively Recruiting
83
Girona University Hospital
Girona, Catalonia, Spain, 17007
Actively Recruiting
84
Arnau de Vilanova University Hospital
Lleida, Catalonia, Spain, 25198
Actively Recruiting
85
Valladolid University Hospital
Valladolid, Spain, 47002
Actively Recruiting
86
John Radcliffe Hospital
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
87
Royal Stoke University Hospital
Stoke-on-Trent, Staffordshire, United Kingdom, ST4 6QG
Actively Recruiting
88
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
Actively Recruiting
89
Queens Medical Centre
Nottingham, United Kingdom
Actively Recruiting
Research Team
J
Joseph P Broderick, MD
CONTACT
J
James Grotta, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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