ACTIVE_NOT_RECRUITING

Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

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Conditions

Intracerebral Hemorrhage

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-03
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03496883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients aged 18-80 years, inclusive
  2. 2. Patients with spontaneous ICH
  3. 3. Able to treat with study medication (rFVIIa/placebo) within 120 minutes of stroke onset or last known well
  4. 4. Efforts to obtain informed consent per EFIC guidelines (U.S.) or adherence to country-specific emergency research informed consent regulations (Canada, Germany, Spain, U.K., Japan)
  1. 1. Score of 3 to 7 on the Glasgow Coma Scale
  2. 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. 3. ICH volume \< 2 cc or ≥ 60 cc
  4. 4. Blood filling 2/3 or more of one lateral ventricle of the brain, OR, blood filling at least 1/3 of both lateral ventricles.
  5. 5. Pre-existing disability (mRS \> 2)
  6. 6. Symptomatic thrombotic or vaso-occlusive disease in past 90 days (e.g., cerebral infarction, myocardial infarction, pulmonary embolus, deep vein thrombosis, or unstable angina)
  7. 7. Clinical or EKG evidence of ST elevation consistent with acute myocardial ischemia
  8. 8. Brainstem location of hemorrhage (patients with cerebellar hemorrhage may be enrolled)
  9. 9. Refusal to participate in study by patient, legal representative, or family member
  10. 10. Known or suspected thrombocytopenia (unless current platelet count documented above 50,000/μL)
  11. 11. Unfractionated heparin use with abnormal PTT
  12. 12. Pro-coagulant drugs within 24 hours prior to patient enrollment into the FASTEST trial (example, tranexamic acid or aminocaproic acid)
  13. 13. Low-molecular weight heparin use within the previous 24 hours
  14. 14. Recent (within 90 days) carotid endarterectomy or coronary or cerebrovascular angioplasty or stenting
  15. 15. Advanced or terminal illness or any other condition the investigator feels would pose a significant hazard to the patient if rFVIIa were administered
  16. 16. 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
  17. 17. Planned withdrawal of care or comfort care measures
  18. 18. Patient known or suspected of not being able to comply with trial protocol (e.g., due to alcoholism, drug dependency, or psychological disorder)
  19. 19. Known or suspected allergy to trial medication(s), excipients, or related products
  20. 20. Contraindications to study medication
  21. 21. Previous participation in this trial (previously randomized)
  22. 22. Females of childbearing potential who are known to be pregnant or within 12 weeks post-partum and/or lactating at time of enrollment

Contacts and Locations

Principal Investigator

Joseph Broderick, MD
PRINCIPAL_INVESTIGATOR
University of Cincinnati

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Joseph Broderick, MD

  • Joseph Broderick, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-03
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2021-12-03
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Intracerebral Hemorrhage