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Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )

Study on BE1116 to help trauma patients with severe bleeding.

Recruiting
15 years and older
All
Phase 3

The TAP Study is a research project to see if a medicine called BE1116 can help people with serious injuries and heavy bleeding to survive better. In this study, volunteers will receive either BE1116 or a placebo (a substance with no active medicine) through an IV (a tube that delivers medicine directly into the vein). This study is "double-blind," which means neither the participants nor the doctors know who gets BE1116 and who gets the placebo. This helps ensure the study results are fair and accurate.

Eligibility: To join, participants need to be at least 15 years old (in some places, the age is higher) and weigh at least 50 kilograms (about 110 pounds). They should have a serious injury with major bleeding or need a lot of blood transfusions.

  • This study involves a single visit for the IV infusion.
  • Participants will be randomly selected to receive either BE1116 or a placebo.
  • There are risks involved, such as possible side effects from the IV infusion.

It is important to know that some people, like those with certain head injuries or on specific blood-thinning medicines, cannot join this study. If you think you might qualify, consider the risks and benefits before deciding to participate.

Study details
    Traumatic Injury

NCT05568888

CSL Behring

13 December 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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