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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05568888




Registration number
NCT05568888
Ethics application status
Date submitted
3/10/2022
Date registered
6/10/2022
Date last updated
4/06/2024

Titles & IDs
Public title
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
Scientific 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
Secondary ID [1] 0 0
2021-005060-21
Secondary ID [2] 0 0
BE1116_3006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic Injury 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BE1116
Treatment: Drugs - Placebo

Experimental: BE1116 - Administration by IV infusion

Placebo Comparator: Placebo - Administration by IV infusion


Treatment: Drugs: BE1116
4-Factor Prothrombin Complex administered by intravenous (IV) infusion

Treatment: Drugs: Placebo
Administered by IV infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference in proportion of subjects in all-cause mortality in the BE1116 arm compared with the placebo arm
Timepoint [1] 0 0
Up to 6 hours after randomization
Secondary outcome [1] 0 0
Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm
Timepoint [1] 0 0
Up to 24 hours after randomization
Secondary outcome [2] 0 0
Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm
Timepoint [2] 0 0
Up to 30 days after randomization
Secondary outcome [3] 0 0
Difference in proportion of subjects who undergo surgical or interventional radiological procedures to stop bleeding related to the primary injury in the BE1116 arm compared with the placebo arm
Timepoint [3] 0 0
Up to 24 hours after randomization
Secondary outcome [4] 0 0
Number and proportion of subjects with serious adverse events (SAEs) considered related to BE1116 or placebo
Timepoint [4] 0 0
Up to 30 days after randomization
Secondary outcome [5] 0 0
Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo
Timepoint [5] 0 0
Up to 30 days after randomization
Secondary outcome [6] 0 0
Number and proportion of subjects with Acute respiratory distress syndrome (ARDS) to BE1116 or placebo
Timepoint [6] 0 0
Up to 30 days after randomization
Secondary outcome [7] 0 0
Number and proportion of subjects with Multiple organ failure to BE1116 or placebo
Timepoint [7] 0 0
Up to 30 days after randomization
Secondary outcome [8] 0 0
Number and proportion of subjects with Acute kidney injury (AKI) requiring renal replacement therapy (dialysis, hemofiltration, or hemodiafiltration) to BE1116 or placebo
Timepoint [8] 0 0
Up to 30 days after randomization

Eligibility
Key inclusion criteria
- (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
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
8000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
LiverpoolNew LambtonNSW,SA,SydneyTAS,VIC,WA
Recruitment hospital [1] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [2] 0 0
John Hunter Hospital - Sydney
Recruitment hospital [3] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment hospital [4] 0 0
Royal Adelaide - Adelaide
Recruitment hospital [5] 0 0
St. George Hospital - Kogarah
Recruitment hospital [6] 0 0
Westmead Hospital - Westmead
Recruitment hospital [7] 0 0
Royal Hobart Hospital - Hobart
Recruitment hospital [8] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [9] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
NSW 2170 - Sydney
Recruitment postcode(s) [2] 0 0
2305 - Sydney
Recruitment postcode(s) [3] 0 0
- Sydney
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
- Kogarah
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3004 - Melbourne
Recruitment postcode(s) [9] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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Arizona
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Arkansas
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Colorado
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Connecticut
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District of Columbia
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Illinois
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Kentucky
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Tennessee
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Birmingham
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Coventry
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Hull
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Sheffield
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Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
CSL Behring
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05568888
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
CSL Behring
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Trial Registration Coordinator
Address 0 0
Country 0 0
Phone 0 0
+1 610-878-4000
Fax 0 0
Email 0 0
clinicaltrials@cslbehring.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05568888