Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- Summary
- 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.
- Short title
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Reason stopped
- Study was terminated early because mortality was lower than expected and a significant increase in sample size would have been required to meet statistical goals of the study. No safety reasons were involved in the decision to terminate the study.
- Completion date
- 2024-10-29
- First posted
- 2022-10-06
- Registry last updated
- 2025-12-10
- Primary completion date
- 2024-10-29
- Start date
- 2023-03-28
- Actual participants
- 1,366
- Participants
- 1,366
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- CSL Behring
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05568888
- ClinicalTrials.gov ID
- NCT05568888
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Proportion of Participants With All-cause 6-hour Mortality
Timeframe: Up to 6 hours after randomization
Here, the percentage of participants with all-cause mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Proportion of Participants With All-cause 24-hour In-hospital Mortality
Timeframe: Up to 24 hours after randomization
In-hospital mortality up to 24 hours after randomization was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization
Timeframe: Up to 30 days after randomization
In-hospital mortality was recorded and assessed for the primary hospitalization only. Here, the percentage of participants with all-cause in hospital mortality has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury
Timeframe: Up to 24 hours after randomization
Here, the percentage of participants with who underwent surgical or interventional radiological procedures to stop bleeding related to the primary injury has been reported. Percentages were rounded off if the second digit after the decimal point is equal to or more than five.
Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs)
Timeframe: Up to 30 days after randomization
The number of participants with treatment-emergent SAEs considered related to IP that occurred during primary hospitalization within the 30 days after randomization are summarized by treatment arm.
Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs)
Timeframe: Up to 30 days after randomization
The TEEs may be symptomatic or asymptomatic, and arterial or venous (eg, deep vein thrombosis, pulmonary embolism, ischemic stroke \[including thromboembolic stroke\], myocardial infarction). The observed in-hospital overall and related to IP TEEs are reported here.
Number of Participants With Acute Respiratory Distress Syndrome (ARDS)
Timeframe: Up to 30 days after randomization
ARDS will be assessed using the Berlin definition based on four criteria: timing, chest imaging, origin of edema, oxygenation (mild, moderate or severe) and high-flow nasal oxygen.
Number of Participants With Multiple Organ Failure
Timeframe: Up to 30 days after randomization
Multiple organ failure will be assessed using the Denver post injury multiple organ failure score. The Denver score rates the dysfunction of 4 organ systems (pulmonary, renal, hepatic, and cardiac), which are each graded on a scale from 0 to 3, where 0 represents "mild" and 3 was "severe". Multiple organ failure is defined as a score \> 3.
Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy
Timeframe: Up to 30 days after randomization
Renal replacement therapy included dialysis, hemofiltration, or hemodiafiltration. AKI according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines is diagnosed if any one of the following happens: • Serum creatinine increases by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours • Serum creatinine increases to ≥ 1.5 times the baseline level, within the past 7 days • Urine levels drops to less than 0.5 mL/kg/hour for 6 hours
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 15 Years
- Healthy volunteers
- No
- (a) Estimated age ≥ 15 years. Older minimum age is required in some locations. FOR United Kingdom: Estimated or actual age ≥ 16 years FOR Australia: Estimated or actual age ≥ 18 years AND (b) Estimated or actual weight ≥ 50 kg (110 lbs).
- Traumatic injury with confirmed or suspected acute major bleeding and/or Revised Assessment of Bleeding and Transfusion (RABT) score ≥ 2
- Activation of massive transfusion protocol
- Healthcare professional cardiopulmonary resuscitation including chest compressions for ≥ 5 consecutive minutes at any time before randomization
- Isolated penetrating or blunt cranial injury, or exposed brain matter
- Isolated burns estimated to be > 20% total body surface area or suspected inhalational injury
- Known anticoagulation treatment or a history of a TEE, within the past 3 months.
- UAB HospitalBirmingham, United States
- University of South AlabamaMobile, United States
- Chandler Regional Medical CenterChandler, United States
- Banner - University Medical Center PhoenixPhoenix, United States
- Valleywise Medical CenterPhoenix, United States
- St. Joseph's Hospital and Medical CenterPhoenix, United States
- HonorHealth Scottsdale Osborn Medical CenterScottsdale, United States
- University Medical Center TucsonTucson, United States
- UAMS Medical CenterLittle Rock, United States
- LAC+USC Medical CenterLos Angeles, United States
- Ronald Reagan UCLA Medical CenterLos Angeles, United States
- Riverside University Health System Medical CenterMoreno Valley, United States
- UC IrvineOrange, United States
- UC Davis Medical CenterSacramento, United States
- UC San Diego Medical CenterSan Diego, United States
- San Francisco General Hospital and Trauma CenterSan Francisco, United States
- University of Colorado AuroraAurora, United States
- UC Health Memorial Hospital CentralColorado Springs, United States
- Denver Health and Hospital AuthorityDenver, United States
- Medical Center of the RockiesLoveland, United States
- Yale New Haven HospitalNew Haven, United States
- MedStar Washington Medical CenterWashington D.C., United States
- George Washington University HospitalWashington D.C., United States
- UF Health JacksonvilleJacksonville, United States
- University of Miami/Ryder Trauma CenterMiami, United States
And 88 more, listed on the interactive page.
Other registry identifiers
- 2021-005060-21