What side effects are associated with this type of intervention?

Common treatments for traumatic injury, especially those involving hemostatic agents like BE1116, aim to control acute major bleeding. These treatments can include agents such as tranexamic acid, recombinant activated factor VII, and fibrinogen concentrates. Known side effects of these hemostatic agents may include thromboembolic events (such as deep vein thrombosis and pulmonary embolism), allergic reactions, and potential interference with normal coagulation processes. It is crucial to balance the benefits of controlling bleeding with the risks of these side effects, and treatment decisions should be made on an individual basis by healthcare professionals.

What prior FDA approvals exist?

The FDA has approved several hemostatic agents for the treatment of traumatic injury to control bleeding. These include tranexamic acid, which is used to reduce blood loss in surgical settings and trauma cases by inhibiting fibrinolysis. Another example is recombinant activated factor VII (rFVIIa), which is used to manage bleeding in patients with hemophilia and has been explored for off-label use in trauma-induced hemorrhage. These agents work by promoting blood clotting and stabilizing clots to prevent excessive bleeding, similar to the investigational drug BE1116 being studied for its efficacy and safety in traumatic injury with major bleeding.

What other types of research exist?

Promising novel alternatives to BE1116 for traumatic injury patients include hemostatic dressings, which have shown effectiveness in military and are transitioning to civilian use, and tranexamic acid (TXA), which is being evaluated in the PATCH-Trauma trial for prehospital use in severe trauma cases.

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Hemostatic Agent

BE1116 for Traumatic Injury

Phase 3

Recruiting

Research Sponsored by CSL Behring

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 24 hours after randomization

Awards & highlights

Pivotal Trial

Summary

This trial is testing BE1116, an IV medicine, in people with severe injuries and heavy bleeding. The goal is to see if it helps their blood clot better to stop or reduce the bleeding.

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.

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.

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 24 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours after randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Difference in proportion of subjects in all-cause in-hospital mortality in the BE1116 arm compared with the placebo arm

Number and proportion of in-hospital overall and related Thromboembolic events (TEEs) to BE1116 or placebo

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial 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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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hemostatic agents, such as those being studied in the BE1116 trial, are crucial in the treatment of traumatic injuries as they promote blood clotting to control acute major bleeding. These agents work by enhancing the body's natural clotting mechanisms, either by inhibiting fibrinolysis (e.g., tranexamic acid) or by providing recombinant clotting factors that directly aid in clot formation. This rapid stabilization of bleeding is vital for improving survival rates and outcomes in trauma patients, as uncontrolled hemorrhage is a leading cause of mortality in such cases.