860
Participants
Start Date
December 3, 2021
Primary Completion Date
January 1, 2028
Study Completion Date
January 1, 2028
Recombinant Activated Factor VII (rFVIIa)
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.
Placebo
Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.
RECRUITING
Mount Sinai West, New York
RECRUITING
The Mount Sinai Hospital, New York
RECRUITING
North Shore University Hospital, Manhasset
RECRUITING
Stony Brook University Hospital, Stony Brook
RECRUITING
Girona University Hospital, Girona
RECRUITING
Temple University Hospital, Philadelphia
RECRUITING
VCU Medical Center, Richmond
RECRUITING
Arnau de Vilanova University Hospital, Lleida
RECRUITING
Wake Forest Baptist Medical Center, Winston-Salem
RECRUITING
Medical University of South Carolina University Hospital, Charleston
RECRUITING
Prisma Health Greenville Memorial Hospital, Greenville
RECRUITING
WellStar Kennestone Hospital, Marietta
RECRUITING
Grady Memorial Hospital, Atlanta
RECRUITING
Mayo Clinic, Jacksonville
RECRUITING
UF Health Shands Hospital, Gainesville
RECRUITING
University of Alabama Hospital, Birmingham
RECRUITING
OSU Wexner Medical Center, Columbus
RECRUITING
Riverside Methodist Hospital, Columbus
RECRUITING
Toledo Hospital, Toledo
RECRUITING
University of Cincinnati Medical Center, Cincinnati
RECRUITING
Henry Ford Hospital, Detroit
RECRUITING
M Health Fairview St. John's Hospital, Maplewood
RECRUITING
M Health Fairview Ridges Hospital,, Burnsville
RECRUITING
M Health Fairview Southdale Hospital, Edina
RECRUITING
M Health Fairview University of Minnesota Medical Center Hospital,, Minneapolis
RECRUITING
Mayo Clinic Saint Marys Campus, Rochester
RECRUITING
Central DuPage Hospital, Winfield
RECRUITING
Northwestern Memorial Hospital, Chicago
RECRUITING
University of Chicago Medical Center, Chicago
RECRUITING
Barnes Jewish Hospital, St Louis
RECRUITING
University Hospital Heidelberg, Heidelberg
RECRUITING
University Hospital Tuebingen, Tübingen
RECRUITING
St. John Medical Center, Tulsa
RECRUITING
Memorial Hermann Memorial City Medical Center, Houston
RECRUITING
Memorial Hermann-Texas Medical Center, Houston
RECRUITING
University of Utah Healthcare, Salt Lake City
RECRUITING
St. Joseph's Hospital and Medical Center, Phoenix
RECRUITING
University Hospital Augsburg, Augsburg
RECRUITING
Kaiser Permanente Los Angeles Medical Center, Los Angeles
RECRUITING
Kaiser Permanente West Los Angeles Medical Center, Los Angeles
RECRUITING
Ronald Reagan UCLA Medical Center, Los Angeles
RECRUITING
Kaiser Permanente Downey Medical Center, Downey
RECRUITING
Kaiser Permanente South Bay Medical Center, Harbor City
RECRUITING
Kaiser Permanente Baldwin Park Medical Center, Baldwin Park
RECRUITING
UCSD Health La Jolla, La Jolla
RECRUITING
UCSD Medical Center - Hillcrest Hospital, San Diego
RECRUITING
Kaiser Permanente Fontana Medical Center, Fontana
RECRUITING
Kaiser Permanente Riverside Medical Center, Riverside
RECRUITING
UC Irvine Medical Center,, Orange
RECRUITING
Mills Peninsula Medical Center, Burlingame
RECRUITING
San Francisco General Hospital, San Francisco
RECRUITING
UC Davis Medical Center, Sacramento
RECRUITING
The Queen's Medical Center, Honolulu
RECRUITING
Providence St. Vincent Medical Center, Portland
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
UMass Memorial Medical Center, Worcester
RECRUITING
University of Calgary - Foothills Medical Centre, Calgary
RECRUITING
Clinic Frankfurt Hoechst, Frankfurt am Main
RECRUITING
Charite University Medicine Berlin, Berlin
RECRUITING
Kyushu Medical Center, Fukuoka
RECRUITING
Gifu University Hospital, Gifu
RECRUITING
Kagoshima City Hospital, Kagoshima
RECRUITING
Kobe City Medical Center General Hospital, Kobe
RECRUITING
Japanese Red Cross Kyoto Daini Hospital, Kyoto
RECRUITING
Iwate Prefectural Central Hospital, Morioka
RECRUITING
Niigata City General Hospital, Niigata
RECRUITING
KMU University Hospital, Osaka
RECRUITING
NHO Osaka National Hospital, Osaka
RECRUITING
Nakamura Memorial Hospital, Sapporo
RECRUITING
Jichi Medical University Hospital, Shimotsuke
RECRUITING
Kyorin University Hospital, Tokyo
RECRUITING
Toranomon Hospital, Tokyo
RECRUITING
Vall d'Hebron University Hospital (VHUH), Horta
RECRUITING
Royal Victoria Infirmary, Newcastle upon Tyne
RECRUITING
Queens Medical Centre, Nottingham
RECRUITING
University of Alberta Hospital, Edmonton
RECRUITING
Vancouver General Hospital, Vancouver
RECRUITING
Hamilton General Hospital, Hamilton
RECRUITING
Ottawa Hospital Research Institute, Ottawa
RECRUITING
Sunnybrook Health Sciences Center, Toronto
RECRUITING
St. Michaels Hospital, Toronto
RECRUITING
University of Montreal Hospital, Montreal
RECRUITING
National Cerebral and Cardiovascular Center, Suita
RECRUITING
Hospital Universitari Germans Trias i Pujol, Badalona
RECRUITING
Bellvitge University Hospital,, L'Hospitalet de Llobregat
RECRUITING
Santa Creu and Sant Pau Hospital, Barcelona
RECRUITING
John Radcliffe Hospital, Oxford
RECRUITING
Royal Stoke University Hospital, Stoke-on-Trent
Collaborators (1)
Novo Nordisk A/S
INDUSTRY
National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Joseph Broderick, MD
OTHER