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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05568888
Ethics application status
Date submitted
3/10/2022
Date registered
6/10/2022

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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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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District of Columbia
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Georgia
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Kentucky
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Louisiana
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Ohio
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Pennsylvania
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Tennessee
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West Virginia
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Wisconsin
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Cambridge
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United Kingdom
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Coventry
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Hull
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Leeds
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Liverpool
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Oxford
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Sheffield
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United Kingdom
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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
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at [email protected].

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
Available to whom?
Proposed research should seek to answer a previously unanswered important medical or scientific question.

Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.

If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05568888