Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

PHASE3TerminatedINTERVENTIONAL
Enrollment

1,370

Participants

Timeline

Start Date

March 28, 2023

Primary Completion Date

October 29, 2024

Study Completion Date

October 29, 2024

Conditions
Traumatic Injury
Interventions
DRUG

BE1116

4-Factor Prothrombin Complex administered by intravenous (IV) infusion

DRUG

Placebo

Administered by IV infusion

Trial Locations (113)

2145

Westmead Hospital, Westmead

2305

John Hunter Hospital, Sydney

3004

Alfred Hospital, Melbourne

5000

Royal Adelaide, Adelaide

6000

Royal Perth Hospital, Perth

7000

Royal Hobart Hospital, Hobart

11418

Jamaica Hospital Medical Center, Richmond Hill

11501

NYU Langone, Mineola

14215

Erie County Medical Center, Buffalo

15213

University of Pittsburgh Medical Center Presbyterian, Pittsburgh

17033

Penn State Milton S. Hershey Medical Center, Hershey

19104

Penn Presbyterian Medical Center, Philadelphia

19140

Temple University Hospital, Philadelphia

19611

Reading Hospital, West Reading

20010

MedStar Washington Medical Center, Washington D.C.

20037

George Washington University Hospital, Washington D.C.

26505

J.W. Ruby Memorial Hospital, Morgantown

27157

Wake Forest Medical Center, Winston-Salem

27710

Duke University, Durham

28203

Carolinas Medical Center, Charlotte

30303

Grady Memorial Hospital, Atlanta

30501

Northeast Georgia Health System, Gainesville

30912

Augusta University Medical Center, Augusta

31201

Atrium Health - Medical Center of central Georgia, Macon

32209

UF Health Jacksonville, Jacksonville

33136

University of Miami/Ryder Trauma Center, Miami

35233

UAB Hospital, Birmingham

36507

University of South Alabama, Mobile

37027

Vanderbilt Hospital and Clinics, Nashville

37403

Erlanger Baroness Hospital, Chattanooga

37920

University of Tennessee Medical Center - UTMCK, Knoxville

38103

Regional Medical Center, Memphis

39216

University of Mississippi Medical Center (UMMC), Jackson

40202

University of Louisville Hospital, Louisville

40536

University of Kentucky Albert B. Chandler Hospital, Lexington

43210

The Ohio State University, Columbus

43608

Mercy Health - St. Vincent Medical Center, Toledo

44109

MetroHealth Medical Center, Cleveland

44304

Summa Health System - Akron Campus, Akron

45219

University of Cincinnati Medical Center, Cincinnati

46202

Indiana University Methodist Hospital, Indianapolis

46260

St. Vincent's Hospital, Indianapolis

48109

University Hospital, Ann Arbor

48202

Henry Ford Hospital, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

53226

Froedtert Memorial Lutheran Hospital, Milwaukee

53792

University Hospital, Madison

55101

Health Partners Regions Hospital, Saint Paul

55415

Hennepin County Medical Center, Minneapolis

55422

North Memorial Hospital, Robbinsdale

57117

Sanford USD Medical Center, Sioux Falls

58104

Sanford Medical Center Fargo, Fargo

60637

University of Chicago Medical Center, Chicago

63104

SSM Health St. Louis, St Louis

63110

Barnes Jewish Hospital, St Louis

66160

Kansas University Medical Center, Kansas City

68198

UNMC (University of Nebraska Medical Center), Omaha

70112

University Medical Center of New Orleans, New Orleans

71103

LSU Health Shreveport, Shreveport

72205

UAMS Medical Center, Little Rock

73104

University of Oklahoma Health Science Center, Oklahoma City

75701

UT Health Tyler, Tyler

76134

JPS Health Network (John Peter Smith Hospital), Fort Worth

77030

Ben Taub General Hospital - Baylor Medical Center - Harris Health Network, Houston

Memorial Hermann Hospital, Houston

78229

University Hospital, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

78701

Dell Seton Medical Center, Austin

79905

University Medical Center El Paso, El Paso

80045

University of Colorado Aurora, Aurora

80204

Denver Health and Hospital Authority, Denver

80538

Medical Center of the Rockies, Loveland

80909

UC Health Memorial Hospital Central, Colorado Springs

84107

Intermountain Medical Center, Murray

84132

University of Utah Hospital, Salt Lake City

85006

Banner - University Medical Center Phoenix, Phoenix

85008

Valleywise Medical Center, Phoenix

85013

St. Joseph's Hospital and Medical Center, Phoenix

85224

Chandler Regional Medical Center, Chandler

85251

HonorHealth Scottsdale Osborn Medical Center, Scottsdale

85719

University Medical Center Tucson, Tucson

90033

LAC+USC Medical Center, Los Angeles

90095

Ronald Reagan UCLA Medical Center, Los Angeles

92103

UC San Diego Medical Center, San Diego

92555

Riverside University Health System Medical Center, Moreno Valley

92868

UC Irvine, Orange

94110

San Francisco General Hospital and Trauma Center, San Francisco

95817

UC Davis Medical Center, Sacramento

97239

Oregon Health and Sciences University Hospital, Portland

98104

Harborview Medical Center, Seattle

06510

Yale New Haven Hospital, New Haven

02111

Tufts Medical Center, Boston

08103

Cooper Health Care, Camden

07103

Rutgers New Jersey Medical School, Newark

08638

Capital Health Regional Medical Center, Trenton

02903

Brown University (Rhode Island Hospital), Providence

NSW 2170

Liverpool Hospital, Sydney

Unknown

Royal Prince Alfred Hospital, Sydney

St. George Hospital, Kogarah

B15 2GW

Queen Elizabeth Hospital, Birmingham

BS10 5NB

Southmead Hospital, Bristol

CB2 0QQ

Cambridge Addenbrookes University, Cambridge

CV2 2DX

University Hospital Coventry, Coventry

HU3 2JZ

Hull Royal Infirmary Hull University Teaching Hospitals NHS Trust, Hull

LS1 3EX

Leeds Teaching Hospital, Leeds

L9 7AL

Aintree University Hospital, Liverpool

SW17 0QT

St. Georges Hospital, London

SW7 1LY

Imperial College Healthcare, London

NE14LP

Royal Victoria Infirmary, Newcastle upon Tyne

NG7 2UH

Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham

OX3 9DU

John Radcliffe Hospital, Oxford

S10 2JF

Sheffield Teaching Hospital, Sheffield

ST4 6QG

Royal Stoke University Hospital, Stoke-on-Trent

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY