Recombinant Factor VIIa (rFVIIa) for Hemorrhagic Stroke Trial

PHASE3RecruitingINTERVENTIONAL
Enrollment

860

Participants

Timeline

Start Date

December 3, 2021

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2028

Conditions
Intracerebral Hemorrhage
Interventions
BIOLOGICAL

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.

BIOLOGICAL

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.

Trial Locations (88)

10019

RECRUITING

Mount Sinai West, New York

10029

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The Mount Sinai Hospital, New York

11030

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North Shore University Hospital, Manhasset

11794

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Stony Brook University Hospital, Stony Brook

17007

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Girona University Hospital, Girona

19140

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Temple University Hospital, Philadelphia

23219

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VCU Medical Center, Richmond

25198

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Arnau de Vilanova University Hospital, Lleida

27157

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Wake Forest Baptist Medical Center, Winston-Salem

29425

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Medical University of South Carolina University Hospital, Charleston

29605

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Prisma Health Greenville Memorial Hospital, Greenville

30060

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WellStar Kennestone Hospital, Marietta

30303

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Grady Memorial Hospital, Atlanta

32224

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Mayo Clinic, Jacksonville

32608

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UF Health Shands Hospital, Gainesville

35233

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University of Alabama Hospital, Birmingham

43210

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OSU Wexner Medical Center, Columbus

43214

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Riverside Methodist Hospital, Columbus

43606

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Toledo Hospital, Toledo

45229

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University of Cincinnati Medical Center, Cincinnati

48208

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Henry Ford Hospital, Detroit

55109

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M Health Fairview St. John's Hospital, Maplewood

55337

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M Health Fairview Ridges Hospital,, Burnsville

55435

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M Health Fairview Southdale Hospital, Edina

55455

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M Health Fairview University of Minnesota Medical Center Hospital,, Minneapolis

55902

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Mayo Clinic Saint Marys Campus, Rochester

60190

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Central DuPage Hospital, Winfield

60611

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Northwestern Memorial Hospital, Chicago

60637

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University of Chicago Medical Center, Chicago

63110

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Barnes Jewish Hospital, St Louis

69120

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University Hospital Heidelberg, Heidelberg

72076

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University Hospital Tuebingen, Tübingen

74104

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St. John Medical Center, Tulsa

77024

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Memorial Hermann Memorial City Medical Center, Houston

77030

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Memorial Hermann-Texas Medical Center, Houston

84132

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University of Utah Healthcare, Salt Lake City

85013

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St. Joseph's Hospital and Medical Center, Phoenix

86156

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University Hospital Augsburg, Augsburg

90027

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Kaiser Permanente Los Angeles Medical Center, Los Angeles

90034

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Kaiser Permanente West Los Angeles Medical Center, Los Angeles

90095

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Ronald Reagan UCLA Medical Center, Los Angeles

90242

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Kaiser Permanente Downey Medical Center, Downey

90710

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Kaiser Permanente South Bay Medical Center, Harbor City

91706

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Kaiser Permanente Baldwin Park Medical Center, Baldwin Park

92037

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UCSD Health La Jolla, La Jolla

92103

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UCSD Medical Center - Hillcrest Hospital, San Diego

92335

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Kaiser Permanente Fontana Medical Center, Fontana

92505

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Kaiser Permanente Riverside Medical Center, Riverside

92868

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UC Irvine Medical Center,, Orange

94010

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Mills Peninsula Medical Center, Burlingame

94110

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San Francisco General Hospital, San Francisco

95817

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UC Davis Medical Center, Sacramento

96813

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The Queen's Medical Center, Honolulu

97225

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Providence St. Vincent Medical Center, Portland

02114

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Massachusetts General Hospital, Boston

01605

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UMass Memorial Medical Center, Worcester

Unknown

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University of Calgary - Foothills Medical Centre, Calgary

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Clinic Frankfurt Hoechst, Frankfurt am Main

RECRUITING

Charite University Medicine Berlin, Berlin

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Kyushu Medical Center, Fukuoka

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Gifu University Hospital, Gifu

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Kagoshima City Hospital, Kagoshima

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Kobe City Medical Center General Hospital, Kobe

RECRUITING

Japanese Red Cross Kyoto Daini Hospital, Kyoto

RECRUITING

Iwate Prefectural Central Hospital, Morioka

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Niigata City General Hospital, Niigata

RECRUITING

KMU University Hospital, Osaka

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NHO Osaka National Hospital, Osaka

RECRUITING

Nakamura Memorial Hospital, Sapporo

RECRUITING

Jichi Medical University Hospital, Shimotsuke

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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

AB T6G 2B7

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University of Alberta Hospital, Edmonton

V5Z 1M9

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Vancouver General Hospital, Vancouver

L8L 2X2

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Hamilton General Hospital, Hamilton

K1H 8L6

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Ottawa Hospital Research Institute, Ottawa

M4N 3M5

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Sunnybrook Health Sciences Center, Toronto

M5B 1W8

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St. Michaels Hospital, Toronto

H2X 3E4

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University of Montreal Hospital, Montreal

564-8565

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National Cerebral and Cardiovascular Center, Suita

21A 08916

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Hospital Universitari Germans Trias i Pujol, Badalona

08907

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Bellvitge University Hospital,, L'Hospitalet de Llobregat

08025

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Santa Creu and Sant Pau Hospital, Barcelona

OX3 9DU

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John Radcliffe Hospital, Oxford

ST4 6QG

RECRUITING

Royal Stoke University Hospital, Stoke-on-Trent

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Joseph Broderick, MD

OTHER