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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
CSL Behring
Study ID
NCT05568888
Phase
PHASE3
Status
Terminated

Conditions

  • Traumatic Injury

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BE1116 — DRUG
    4-Factor Prothrombin Complex administered by intravenous (IV) infusion
  • Placebo — DRUG
    Administered by IV infusion

Study Details

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.

Key Dates

First listed
Oct 6, 2022
Start date
Mar 28, 2023
Status verified
Nov 2025
Primary completion
Oct 29, 2024
Completion
Oct 29, 2024

Study Design

Enrollment
1,366 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BE1116
    Administration by IV infusion
  • Placebo Comparator: Placebo
    Administration by IV infusion

Primary Outcome Measure

Proportion of Participants With All-cause 6-hour Mortality [ Time Frame: Up to 6 hours after randomization ]

Locations (90)

FacilityCityStateZIPSite coordinators
UAB HospitalBirminghamAlabama35233-
University of South AlabamaMobileAlabama36507-
Chandler Regional Medical CenterChandlerArizona85224-
Banner - University Medical Center PhoenixPhoenixArizona85006-
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
Valleywise Medical CenterPhoenixArizona85008-
HonorHealth Scottsdale Osborn Medical CenterScottsdaleArizona85251-
University Medical Center TucsonTucsonArizona85719-
UAMS Medical CenterLittle RockArkansas72205-
LAC+USC Medical CenterLos AngelesCalifornia90033-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
Riverside University Health System Medical CenterMoreno ValleyCalifornia92555-
UC IrvineOrangeCalifornia92868-
UC Davis Medical CenterSacramentoCalifornia95817-
UC San Diego Medical CenterSan DiegoCalifornia92103-
San Francisco General Hospital and Trauma CenterSan FranciscoCalifornia94110-
University of Colorado AuroraAuroraColorado80045-
UC Health Memorial Hospital CentralColorado SpringsColorado80909-
Denver Health and Hospital AuthorityDenverColorado80204-
Medical Center of the RockiesLovelandColorado80538-
Yale New Haven HospitalNew HavenConnecticut06510-
George Washington University HospitalWashington D.C.District of Columbia20037-
MedStar Washington Medical CenterWashington D.C.District of Columbia20010-
UF Health JacksonvilleJacksonvilleFlorida32209-
University of Miami/Ryder Trauma CenterMiamiFlorida33136-
Grady Memorial HospitalAtlantaGeorgia30303-
Augusta University Medical CenterAugustaGeorgia30912-
Northeast Georgia Health SystemGainesvilleGeorgia30501-
Atrium Health - Medical Center of central GeorgiaMaconGeorgia31201-
University of Chicago Medical CenterChicagoIllinois60637-
Indiana University Methodist HospitalIndianapolisIndiana46202-
St. Vincent's HospitalIndianapolisIndiana46260-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Kansas University Medical CenterKansas CityKansas66160-
University of Kentucky Albert B. Chandler HospitalLexingtonKentucky40536-
University of Louisville HospitalLouisvilleKentucky40202-
University Medical Center of New OrleansNew OrleansLouisiana70112-
LSU Health ShreveportShreveportLouisiana71103-
Tufts Medical CenterBostonMassachusetts02111-
University HospitalAnn ArborMichigan48109-
Henry Ford HospitalDetroitMichigan48202-
Hennepin County Medical CenterMinneapolisMinnesota55415-
North Memorial HospitalRobbinsdaleMinnesota55422-
Health Partners Regions HospitalSaint PaulMinnesota55101-
University of Mississippi Medical Center (UMMC)JacksonMississippi39216-
Barnes Jewish HospitalSt LouisMissouri63110-
SSM Health St. LouisSt LouisMissouri63104-
UNMC (University of Nebraska Medical Center)OmahaNebraska68198-
Cooper Health CareCamdenNew Jersey08103-
Rutgers New Jersey Medical SchoolNewarkNew Jersey07103-
Capital Health Regional Medical CenterTrentonNew Jersey08638-
Erie County Medical CenterBuffaloNew York14215-
NYU LangoneMineolaNew York11501-
Jamaica Hospital Medical CenterRichmond HillNew York11418-
Carolinas Medical CenterCharlotteNorth Carolina28203-
Duke UniversityDurhamNorth Carolina27710-
Wake Forest Medical CenterWinston-SalemNorth Carolina27157-
Sanford Medical Center FargoFargoNorth Dakota58104-
Summa Health System - Akron CampusAkronOhio44304-
University of Cincinnati Medical CenterCincinnatiOhio45219-
MetroHealth Medical CenterClevelandOhio44109-
The Ohio State UniversityColumbusOhio43210-
Mercy Health - St. Vincent Medical CenterToledoOhio43608-
University of Oklahoma Health Science CenterOklahoma CityOklahoma73104-
Oregon Health and Sciences University HospitalPortlandOregon97239-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Penn Presbyterian Medical CenterPhiladelphiaPennsylvania19104-
Temple University HospitalPhiladelphiaPennsylvania19140-
University of Pittsburgh Medical Center PresbyterianPittsburghPennsylvania15213-
Reading HospitalWest ReadingPennsylvania19611-
Brown University (Rhode Island Hospital)ProvidenceRhode Island02903-
Sanford USD Medical CenterSioux FallsSouth Dakota57117-
Erlanger Baroness HospitalChattanoogaTennessee37403-
University of Tennessee Medical Center - UTMCKKnoxvilleTennessee37920-
Regional Medical CenterMemphisTennessee38103-
Vanderbilt Hospital and ClinicsNashvilleTennessee37027-
Dell Seton Medical CenterAustinTexas78701-
University Medical Center El PasoEl PasoTexas79905-
Brooke Army Medical CenterFort Sam HoustonTexas78234-
JPS Health Network (John Peter Smith Hospital)Fort WorthTexas76134-
Ben Taub General Hospital - Baylor Medical Center - Harris Health NetworkHoustonTexas77030-
Memorial Hermann HospitalHoustonTexas77030-
University HospitalSan AntonioTexas78229-
UT Health TylerTylerTexas75701-
Intermountain Medical CenterMurrayUtah84107-
University of Utah HospitalSalt Lake CityUtah84132-
Harborview Medical CenterSeattleWashington98104-
J.W. Ruby Memorial HospitalMorgantownWest Virginia26505-
University HospitalMadisonWisconsin53792-
Froedtert Memorial Lutheran HospitalMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
UAB Hospital· Birmingham, ALUniversity of South Alabama· Mobile, ALChandler Regional Medical Center· Chandler, AZBanner - University Medical Center Phoenix· Phoenix, AZSt. Joseph's Hospital and Medical Center· Phoenix, AZValleywise Medical Center· Phoenix, AZ

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