Clinical Trials Logo
  1. Home
  2. Traumatic Injury
  3. NCT05568888

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

Traumatic Injury Clinical Trial

Official 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

Clinical Trial Summary

This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and / or predicted to receive a large volume blood product transfusion.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05568888
Study type Interventional
Source CSL Behring
Contact Trial Registration Coordinator
Phone +1 610-878-4000
Email clinicaltrials@cslbehring.com
Status Recruiting
Phase Phase 3
Start date March 28, 2023
Completion date September 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04992130 - Sport Concussion Performance-Based Prevention Program N/A
Recruiting NCT05451394 - Prevention of Injury in Military Settings Through the Use of Body Awareness. N/A
Withdrawn NCT03928015 - Evaluation of Dronabinol For Acute Pain Following Traumatic Injury Phase 2
Recruiting NCT04588311 - ErythroPOietin Alfa to Prevent Mortality and Reduce Severe Disability in Critically Ill TRAUMA Patients Phase 3
Recruiting NCT05437575 - Prehospital Analgesia INtervention Trial (PAIN) Phase 3
Recruiting NCT06034834 - Near-Infrared Imaging for Perfusion Assessment of Traumatic Soft Tissue and Skeletal Injuries N/A
Completed NCT02412982 - Evaluation of Venous Thromboembolism Prevention in High-Risk Trauma Patients Phase 4
Withdrawn NCT01497678 - Musculotendinous Tissue Unit Repair and Reinforcement (MTURR) Coordinating Center N/A
Completed NCT05225441 - National Investigation in College and High School Among Adolescents on Health and Substances at the FSEF
Completed NCT03927729 - Use of Methoxyflurane (Penthrox) as an Antalgic in Hospital Trauma N/A
Not yet recruiting NCT06383650 - Use of 81 vs 325mg of ASA in Treatment of BCVI Early Phase 1
Not yet recruiting NCT06366282 - Pediatric and Caregiver Traumatic Stress Intervention (PACTS) N/A
Completed NCT04778332 - Trottinettes Urgences 2019-2020
Recruiting NCT06404177 - Enantyum® IV Versus Piroxen® IM in Emergency Pain Management Phase 3
Recruiting NCT05086757 - Evaluation of Trauma Center-Based Intervention for Adolescent Traumatic Injury Survivors N/A
Completed NCT03628846 - Opioid Use After Traumatic Injury in Adolescents
Active, not recruiting NCT05320445 - A Psychosocial Transitional Group to Improve Adaptation, Coping and Mental Health Outcomes Following Trauma N/A
Completed NCT01771055 - Direct Peritoneal Resuscitation Effects in the Damage Control Patient N/A
Completed NCT01485419 - Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy N/A
Completed NCT04980937 - Peroneal Nerve Injury: a 20- Year Retrospective Case Series Study