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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 hours after randomization
Awards & highlights
Study Summary
This trial tests a single IV infusion to improve safety for people with major bleeding due to trauma and needing a lot of blood transfusions.
Who is the study for?
This trial is for individuals aged 15 or older who weigh more than 110 lbs and have experienced a traumatic injury with major bleeding. They must be predicted to need lots of blood product transfusions, with a RABT score of at least 2. People can't join if they've had only head injuries with exposed brain matter, recent anticoagulant treatment or thromboembolic events, prolonged CPR before enrollment, or severe burns/inhalation injuries.Check my eligibility
What is being tested?
The TAP Study tests the effectiveness and safety of BE1116 given through an IV once versus a placebo in patients with traumatic injuries and significant bleeding. Participants are randomly assigned to either receive BE1116 or the placebo in this double-blind study where neither they nor the researchers know who gets what.See study design
What are the potential side effects?
While specific side effects for BE1116 aren't listed here, common risks may include reactions at the infusion site, potential allergic responses, and any unforeseen complications related to bleeding conditions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 6 hours after randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 hours after randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Perinatal death
Secondary outcome measures
Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm
Hemorrhage
Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BE1116Experimental Treatment1 Intervention
Administration by IV infusion
Group II: PlaceboPlacebo Group1 Intervention
Administration by IV infusion
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Who is running the clinical trial?
CSL BehringLead Sponsor
194 Previous Clinical Trials
1,203,066 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,211 Previous Clinical Trials
481,272 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a traumatic injury with major bleeding or a high risk of needing a blood transfusion.I am at least 15 years old and weigh more than 50 kg (110 lbs).I have undergone a massive blood transfusion.I have undergone CPR for 5 minutes or more before joining this study.I have burns on more than 20% of my body or I might have inhaled smoke.I have had a severe head injury with exposed brain matter.I am on blood thinners or had a clotting event in the last 3 months.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: BE1116
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment of participants currently ongoing for this trial?
"This research project, first published on 15th March 2023 and last edited 28th of the same month, is no longer looking for volunteers. However, there are still 763 other studies actively seeking participants at this moment in time."
Answered by AI
How many locations are supervising this research endeavor?
"At present, 93 clinics are participating in this clinical trial. These sites span across Mobile, Chandler, Phoenix and other cities. It is recommended to join the nearest clinic for minimal travel requirements if one decides to enroll."
Answered by AI
Has BE1116 received authorization from the U.S. Food and Drug Administration?
"There is evidence suggesting that BE1116 has a certain degree of efficacy, while prior clinical data supports it's safety; thus, our team at Power assign this medication a score of 3."
Answered by AI
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