BE1116_3006

• Research type

  Research Study

• Full 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

• IRAS ID

  1004403

• Contact name

  Brahm Goldstein

• Contact email

  clinicaltrials@cslbehring.com

• Sponsor organisation

  CSL Behring LLC

• Eudract number

  2021-005060-21

• Clinicaltrials.gov Identifier

  NCT05568888

• Research summary

  This study is being carried out to see if BE1116 (4 Factor Prothrombin Complex Concentrate), also known as Beriplex, is effective in treating people whose injuries require blood transfusions to help control or stop bleeding. BE1116 contains a concentration of clotting factors that are normally present in the blood. BE1116 is approved to stop bleeding in patients with major bleeding while on Vitamin K antagonists (blood thinners such as warfarin). BE1116 is not approved to treat patients with injuries who require blood transfusions and are at high risk of dying. This clinical research study is testing whether BE1116 reduces the risk of dying and is sponsored and funded by CSL Behring.
  
  This study may help doctors learn more about how safe and effective BE1116 is in treating patients with injury who require blood transfusions and are at high risk of dying to reduce their chances of dying by helping control or stop bleeding. The study is divided into 3 parts: Screening, and Randomisation (Enrolment), Treatment, and In-hospital Follow-Up. This study would take place during the first 30 days of the patient’s hospital stay. Patients would be enrolled in study under special rules for studies on trauma patients who cannot consent to study participation during an emergency. This study includes patients who are at a high risk of dying from blood loss because they are bleeding or at high risk of bleeding. Once a patient is enrolled, the patient will receive either BE1116 or placebo (a substance that looks like BE1116 but doesn’t have active medicine). The treatment the patient will receive is decided at random. The patient will have an equal chance of receiving BE1116 or placebo. Up to about 8000 patients will take part in the study at up to about 120 hospitals around the world.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  22/NE/0196

• Date of REC Opinion

  3 Feb 2023

• REC opinion

  Further Information Favourable Opinion