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Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial
NCT03496883 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Recombinant Activated Factor VII (rFVIIa)
Study Locations (20)
California
- Kaiser Permanente Baldwin Park Medical Center — Baldwin Park
- Mills Peninsula Medical Center — Burlingame
- Kaiser Permanente Downey Medical Center — Downey
- Kaiser Permanente Fontana Medical Center — Fontana
- Kaiser Permanente South Bay Medical Center — Harbor City
- UCSD Health La Jolla — La Jolla
- Kaiser Permanente Los Angeles Medical Center — Los Angeles
- Kaiser Permanente West Los Angeles Medical Center — Los Angeles
- Ronald Reagan UCLA Medical Center — Los Angeles
- UC Irvine Medical Center, — Orange
- Kaiser Permanente Riverside Medical Center — Riverside
- UC Davis Medical Center — Sacramento
- UCSD Medical Center - Hillcrest Hospital — San Diego
- San Francisco General Hospital — San Francisco
Florida
- UF Health Shands Hospital — Gainesville
- Mayo Clinic — Jacksonville
Georgia
- Grady Memorial Hospital — Atlanta
- WellStar Kennestone Hospital — Marietta
Alabama
- University of Alabama Hospital — Birmingham
Arizona
- St. Joseph's Hospital and Medical Center — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 860 participants |
| Start Date | 2021-12-03 |
| Est. Completion | 2028-01-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03496883
The ClinicalTrials.gov registry entry for NCT03496883 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 860 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph Broderick, MD, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Intracerebral Hemorrhage appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03496883 reports 20 study locations spanning 5 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03496883 about?
NCT03496883 is a clinical study titled "Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial". 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...
What is the current status of trial NCT03496883?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 860 participants. The study started on 2021-12-03. Estimated completion is 2028-01-01.
What conditions does trial NCT03496883 study?
This clinical trial studies the following conditions: Intracerebral Hemorrhage. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03496883?
The interventions under investigation include: Placebo (BIOLOGICAL), Recombinant Activated Factor VII (rFVIIa) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03496883?
This trial is sponsored by Joseph Broderick, MD, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03496883 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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