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Active, not recruiting Phase 3 Interventional

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

ClinicalTrials.gov ID: NCT03496883

Public ClinicalTrials.gov record NCT03496883. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 11:37 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Recombinant Factor VIIa (rFVIIa) for Acute Hemorrhagic Stroke Administered at Earliest Time (FASTEST) Trial

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 180 days as measured by the Modified Rankin Score (mRS) and decrease ongoing bleeding as compared to standard therapy.

Study identification

NCT ID
NCT03496883
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Joseph Broderick, MD
Other
Enrollment
860 participants

Conditions and interventions

Interventions

Biological

Eligibility (public fields only)

Age range
18 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 3, 2021 (Actual)
Primary completion
Jan 1, 2028 (Estimated)
Completion
Jan 1, 2028 (Estimated)
Last update posted
Jan 21, 2026

2021 – 2028

United States locations

U.S. sites
51
U.S. states
21
U.S. cities
45
Facility City State ZIP Site status
University of Alabama Hospital Birmingham Alabama 35233 —
St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 —
Kaiser Permanente Baldwin Park Medical Center Baldwin Park California 91706 —
Mills Peninsula Medical Center Burlingame California 94010 —
Kaiser Permanente Downey Medical Center Downey California 90242 —
Kaiser Permanente Fontana Medical Center Fontana California 92335 —
Kaiser Permanente South Bay Medical Center Harbor City California 90710 —
UCSD Health La Jolla La Jolla California 92037 —
Kaiser Permanente Los Angeles Medical Center Los Angeles California 90027 —
Kaiser Permanente West Los Angeles Medical Center Los Angeles California 90034 —
Ronald Reagan UCLA Medical Center Los Angeles California 90095 —
UC Irvine Medical Center, Orange California 92868 —
Kaiser Permanente Riverside Medical Center Riverside California 92505 —
UC Davis Medical Center Sacramento California 95817 —
UCSD Medical Center - Hillcrest Hospital San Diego California 92103 —
San Francisco General Hospital San Francisco California 94110 —
UF Health Shands Hospital Gainesville Florida 32608 —
Mayo Clinic Jacksonville Florida 32224 —
Grady Memorial Hospital Atlanta Georgia 30303 —
WellStar Kennestone Hospital Marietta Georgia 30060 —
The Queen's Medical Center Honolulu Hawaii 96813 —
Northwestern Memorial Hospital Chicago Illinois 60611 —
University of Chicago Medical Center Chicago Illinois 60637 —
Central DuPage Hospital Winfield Illinois 60190 —
Massachusetts General Hospital Boston Massachusetts 02114 —
UMass Memorial Medical Center Worcester Massachusetts 01605 —
Henry Ford Hospital Detroit Michigan 48208 —
M Health Fairview Ridges Hospital, Burnsville Minnesota 55337 —
M Health Fairview Southdale Hospital Edina Minnesota 55435 —
M Health Fairview St. John's Hospital Maplewood Minnesota 55109 —
M Health Fairview University of Minnesota Medical Center Hospital, Minneapolis Minnesota 55455 —
Mayo Clinic Saint Marys Campus Rochester Minnesota 55902 —
Barnes Jewish Hospital St Louis Missouri 63110 —
North Shore University Hospital Manhasset New York 11030 —
Mount Sinai West New York New York 10019 —
The Mount Sinai Hospital New York New York 10029 —
Stony Brook University Hospital Stony Brook New York 11794 —
Wake Forest Baptist Medical Center Winston-Salem North Carolina 27157 —
University of Cincinnati Medical Center Cincinnati Ohio 45229 —
OSU Wexner Medical Center Columbus Ohio 43210 —
Riverside Methodist Hospital Columbus Ohio 43214 —
Toledo Hospital Toledo Ohio 43606 —
St. John Medical Center Tulsa Oklahoma 74104 —
Providence St. Vincent Medical Center Portland Oregon 97225 —
Temple University Hospital Philadelphia Pennsylvania 19140 —
Medical University of South Carolina University Hospital Charleston South Carolina 29425 —
Prisma Health Greenville Memorial Hospital Greenville South Carolina 29605 —
Memorial Hermann Memorial City Medical Center Houston Texas 77024 —
Memorial Hermann-Texas Medical Center Houston Texas 77030 —
University of Utah Healthcare Salt Lake City Utah 84132 —
VCU Medical Center Richmond Virginia 23219 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03496883, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 21, 2026 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03496883 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →