Trial · NCT05568888
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
NCT05568888, Phase 3, Terminated, CSL Behring; results first posted 2025-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ). Trials, record NCT05568888. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05568888
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
- NCT number
- NCT05568888
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 1,366 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Traumatic Injury
- Interventions
- BE1116, Placebo
- First posted
- 2022-10-06
- Last updated
- 2025-12-10
- Other registries' IDs
- eudract:2021-005060-21
- Results first posted
- 2025-11-10
- Limitations and caveats
- The study was terminated due to feasibility reasons. No safety issues contributed to the decision to terminate the study.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With All-cause 6-hour Mortality | 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. |
| Secondary | Proportion of Participants With All-cause 24-hour In-hospital Mortality | 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. |
| Secondary | Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization | 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. |
| Secondary | Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury | 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. |
| Secondary | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | 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. |
| Secondary | Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs) | 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. |
| Secondary | Number of Participants With Acute Respiratory Distress Syndrome (ARDS) | 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. |
| Secondary | Number of Participants With Multiple Organ Failure | 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. |
| Secondary | Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy | 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 |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With All-cause 6-hour Mortality | Up to 6 hours after randomization | Analysis was performed on the ITT and modified ITT (mITT) population. The ITT population included all the randomized participants. The mITT population included all participants from ITT population who received at least one complete or partial dose of the investigational product (IP) (BE1116 or placebo). It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization. | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With All-cause 24-hour In-hospital Mortality | Up to 24 hours after randomization | As planned, analysis was performed on the mITT population. The mITT population included all participants from ITT population who received at least one complete or partial dose of BE1116 or placebo. It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization. | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization | Up to 30 days after randomization | As planned, analysis was performed on the mITT population. The mITT population included all participants from ITT population who received at least one complete or partial dose of BE1116 or placebo. It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization. | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury | Up to 24 hours after randomization | As planned, analysis was performed on the mITT population. The mITT population included all participants from ITT population who received at least one complete or partial dose of BE1116 or placebo. It also included participants with a missing or non-testable Glasgow Coma Score, or a score less than 15, as well as those who received blood product transfusions prior to randomization. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Serious Adverse Events (SAEs) | Up to 30 days after randomization | Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received. | Count of participants | NUMBER |
| SECONDARY | Number of Participants With In-hospital Overall and Related Thromboembolic Events (TEEs) | Up to 30 days after randomization | Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received. | Count of participants | NUMBER |
| SECONDARY | Number of Participants With Acute Respiratory Distress Syndrome (ARDS) | Up to 30 days after randomization | Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received. | Count of participants | NUMBER |
| SECONDARY | Number of Participants With Multiple Organ Failure | Up to 30 days after randomization | Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received. | Count of participants | NUMBER |
| SECONDARY | Number of Participants With Acute Kidney Injury (AKI) Requiring Renal Replacement Therapy | Up to 30 days after randomization | Analysis was performed on the safety population. The safety population included of all the participants from ITT population who received at least one complete or partial dose of BE1116 or placebo, based on the treatment actually received. | Count of participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With All-cause 6-hour Mortality | BE1116 | All-cause Mortality in ITT Analysis Set | 7.3 | Percentage of participants | |
| Proportion of Participants With All-cause 6-hour Mortality | Placebo | All-cause Mortality in ITT Analysis Set | 4.6 | Percentage of participants | |
| Proportion of Participants With All-cause 6-hour Mortality | BE1116 | All-cause Mortality in mITT Analysis Set | 7.2 | Percentage of participants | |
| Proportion of Participants With All-cause 6-hour Mortality | Placebo | All-cause Mortality in mITT Analysis Set | 4.1 | Percentage of participants | |
| Proportion of Participants With All-cause 24-hour In-hospital Mortality | BE1116 | 11.1 | Percentage of participants | ||
| Proportion of Participants With All-cause 24-hour In-hospital Mortality | Placebo | 7.3 | Percentage of participants | ||
| Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization | BE1116 | 24.8 | Percentage of participants | ||
| Proportion of Participants With All-cause In-hospital Mortality Up to 30 Days After Randomization | Placebo | 18.6 | Percentage of participants | ||
| Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury | BE1116 | 78.0 | Percentage of participants | ||
| Proportion of Participants Who Underwent Surgical or Interventional Radiological Procedures to Stop Bleeding Related to the Primary Injury | Placebo | 75.5 | Percentage of participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BE1116 | 689 | |
| Overall Study | STARTED | Placebo | 677 | |
| Overall Study | Treated | BE1116 | 618 | |
| Overall Study | Treated | Placebo | 627 | |
| Overall Study | COMPLETED | BE1116 | 628 | |
| Overall Study | COMPLETED | Placebo | 605 | |
| Overall Study | NOT COMPLETED | BE1116 | 61 | |
| Overall Study | NOT COMPLETED | Placebo | 72 |
Source ClinicalTrials.gov
Adverse events362
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Deep vein thrombosis | Vascular disorders | BE1116 | 32 | 618 | 41 |
| other | Deep vein thrombosis | Vascular disorders | Placebo | 39 | 627 | 44 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | BE1116 | 42 | 618 | 44 |
| serious | Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Placebo | 48 | 627 | 50 |
| serious | Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | BE1116 | 18 | 618 | 18 |
| serious | Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | Placebo | 21 | 627 | 21 |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | BE1116 | 10 | 618 | 10 |
| serious | Respiratory failure | Respiratory, thoracic and mediastinal disorders | Placebo | 5 | 627 | 5 |
| serious | Acute Respiratory failure | Respiratory, thoracic and mediastinal disorders | BE1116 | 7 | 618 | 7 |
| serious | Acute Respiratory failure | Respiratory, thoracic and mediastinal disorders | Placebo | 4 | 627 | 4 |
1 to 10 of 362Source ClinicalTrials.gov
See all 362 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BE1116 | 146 | 689 |
| Total, all-cause mortality | Placebo | 114 | 677 |
| Total, other adverse events | BE1116 | 32 | 618 |
| Total, other adverse events | Placebo | 39 | 627 |
| Total, serious adverse events | BE1116 | 203 | 618 |
| Total, serious adverse events | Placebo | 168 | 627 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| BE1116 vs Placebo: deaths from any cause | Trial comparisons |
| BE1116 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05568888
GET https://conductscience.org/api/trials/v1/NCT05568888/results?page=2