Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
Public ClinicalTrials.gov record NCT05568888. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients With Traumatic Injury and Acute Major Bleeding
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05568888
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,366 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 15 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 28, 2023 (Actual)
- Primary completion
- Oct 29, 2024 (Actual)
- Completion
- Oct 29, 2024 (Actual)
- Last update posted
- Dec 10, 2025
2023 – 2024
United States locations
- U.S. sites
- 90
- U.S. states
- 37
- U.S. cities
- 82
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Hospital | Birmingham | Alabama | 35233 | — |
| University of South Alabama | Mobile | Alabama | 36507 | — |
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | — |
| Banner - University Medical Center Phoenix | Phoenix | Arizona | 85006 | — |
| Valleywise Medical Center | Phoenix | Arizona | 85008 | — |
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | — |
| HonorHealth Scottsdale Osborn Medical Center | Scottsdale | Arizona | 85251 | — |
| University Medical Center Tucson | Tucson | Arizona | 85719 | — |
| UAMS Medical Center | Little Rock | Arkansas | 72205 | — |
| LAC+USC Medical Center | Los Angeles | California | 90033 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| Riverside University Health System Medical Center | Moreno Valley | California | 92555 | — |
| UC Irvine | Orange | California | 92868 | — |
| UC Davis Medical Center | Sacramento | California | 95817 | — |
| UC San Diego Medical Center | San Diego | California | 92103 | — |
| San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | — |
| University of Colorado Aurora | Aurora | Colorado | 80045 | — |
| UC Health Memorial Hospital Central | Colorado Springs | Colorado | 80909 | — |
| Denver Health and Hospital Authority | Denver | Colorado | 80204 | — |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | — |
| Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| MedStar Washington Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| George Washington University Hospital | Washington D.C. | District of Columbia | 20037 | — |
| UF Health Jacksonville | Jacksonville | Florida | 32209 | — |
| University of Miami/Ryder Trauma Center | Miami | Florida | 33136 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Augusta University Medical Center | Augusta | Georgia | 30912 | — |
| Northeast Georgia Health System | Gainesville | Georgia | 30501 | — |
| Atrium Health - Medical Center of central Georgia | Macon | Georgia | 31201 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Indiana University Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| St. Vincent's Hospital | Indianapolis | Indiana | 46260 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Kansas University Medical Center | Kansas City | Kansas | 66160 | — |
| University of Kentucky Albert B. Chandler Hospital | Lexington | Kentucky | 40536 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| University Medical Center of New Orleans | New Orleans | Louisiana | 70112 | — |
| LSU Health Shreveport | Shreveport | Louisiana | 71103 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| University Hospital | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Hennepin County Medical Center | Minneapolis | Minnesota | 55415 | — |
| North Memorial Hospital | Robbinsdale | Minnesota | 55422 | — |
| Health Partners Regions Hospital | Saint Paul | Minnesota | 55101 | — |
| University of Mississippi Medical Center (UMMC) | Jackson | Mississippi | 39216 | — |
| SSM Health St. Louis | St Louis | Missouri | 63104 | — |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | — |
| UNMC (University of Nebraska Medical Center) | Omaha | Nebraska | 68198 | — |
| Cooper Health Care | Camden | New Jersey | 08103 | — |
| Rutgers New Jersey Medical School | Newark | New Jersey | 07103 | — |
| Capital Health Regional Medical Center | Trenton | New Jersey | 08638 | — |
| Erie County Medical Center | Buffalo | New York | 14215 | — |
| NYU Langone | Mineola | New York | 11501 | — |
| Jamaica Hospital Medical Center | Richmond Hill | New York | 11418 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28203 | — |
| Duke University | Durham | North Carolina | 27710 | — |
| Wake Forest Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Sanford Medical Center Fargo | Fargo | North Dakota | 58104 | — |
| Summa Health System - Akron Campus | Akron | Ohio | 44304 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Mercy Health - St. Vincent Medical Center | Toledo | Ohio | 43608 | — |
| University of Oklahoma Health Science Center | Oklahoma City | Oklahoma | 73104 | — |
| Oregon Health and Sciences University Hospital | Portland | Oregon | 97239 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| University of Pittsburgh Medical Center Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| Reading Hospital | West Reading | Pennsylvania | 19611 | — |
| Brown University (Rhode Island Hospital) | Providence | Rhode Island | 02903 | — |
| Sanford USD Medical Center | Sioux Falls | South Dakota | 57117 | — |
| Erlanger Baroness Hospital | Chattanooga | Tennessee | 37403 | — |
| University of Tennessee Medical Center - UTMCK | Knoxville | Tennessee | 37920 | — |
| Regional Medical Center | Memphis | Tennessee | 38103 | — |
| Vanderbilt Hospital and Clinics | Nashville | Tennessee | 37027 | — |
| Dell Seton Medical Center | Austin | Texas | 78701 | — |
| University Medical Center El Paso | El Paso | Texas | 79905 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| JPS Health Network (John Peter Smith Hospital) | Fort Worth | Texas | 76134 | — |
| Ben Taub General Hospital - Baylor Medical Center - Harris Health Network | Houston | Texas | 77030 | — |
| Memorial Hermann Hospital | Houston | Texas | 77030 | — |
| University Hospital | San Antonio | Texas | 78229 | — |
| UT Health Tyler | Tyler | Texas | 75701 | — |
| Intermountain Medical Center | Murray | Utah | 84107 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Harborview Medical Center | Seattle | Washington | 98104 | — |
| J.W. Ruby Memorial Hospital | Morgantown | West Virginia | 26505 | — |
| University Hospital | Madison | Wisconsin | 53792 | — |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 23 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05568888, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 10, 2025 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05568888 live on ClinicalTrials.gov.