UAB/CSL Behring study to investigate blood-clotting agent as treatment for injured patients who are bleeding

The study seeks to determine whether prothrombin complex concentrate, a blood-clotting agent, could help save the lives of patients at risk for severe bleeding after injury.
Written by: Allie Hulcher
Media contact: Bob Shepard

Inside trauma gurney in OR hallway 18 1The study will see if a clotting medication will help control bleeding in trauma patients.

Bleeding out is the most common cause of preventable death after injury. Researchers at the University of Alabama at Birmingham are leading an international study to see whether a blood-clotting agent, given soon after arrival in the emergency department, can improve survival.

The Center for Injury Science, in the UAB Marnix E. Heersink School of Medicine, have partnered with CSL Behring to help conduct the study, which is one of the largest clinical trials ever conducted in the field of trauma.

The Trauma and Prothrombin Complex Concentrate, or TAP, trial will determine whether prothrombin complex concentrate, also known as Kcentra® / Beriplex®, reduces mortality in trauma patients who are predicted to require large volume blood transfusions. PCC is a medication containing multiple blood-clotting factors and is currently approved for use as a therapy for hemophilia and to reverse the effects of anticoagulant medications, such as warfarin.

The trial’s overall lead is Jan Jansen, MBBS, Ph.D., director of CIS. Jansen is the associate vice chair for Clinical Trials, the director of Research, and a professor in the Division of Trauma and Acute Care Surgery. John Holcomb, M.D., a professor in the division and CIS senior scientist, is the co-lead. Shannon Stephens, CCEMTP, executive director of CIS, is the program manager.

CSL Behring, a global biotherapeutics leader which makes PCC, is sponsoring the TAP trial in collaboration with UAB’s CIS.  The trial will demonstrate whether trauma patients who are not on blood-thinning medications could benefit from PCC’s ability to promote clotting and slow bleeding. If shown to be effective, treatment with PCC could transform the standard of care for bleeding trauma patients and save thousands of lives.

Inside UAB ProviderDirectory2020 JanJansen RTJan Jansen, MBBS, is the director of research for the UAB Division of Trauma and Acute Care Surgery

The TAP trial will be conducted in about 120 leading trauma centers in several countries and will include 8,000 patients, making it the second-largest trauma trial ever conducted.

Since trauma patients cannot give informed consent, the trial will utilize federal guidelines for exception from informed consent. CSL Behring will meet federal regulations with support from UAB’s CIS for conducting such trials by using innovative, media-based methods pioneered by Stephens for educating and engaging with communities across the United States. UAB is the only institution in the United States to have led interactive, media-based community consultations for multi-center trials.

The Center for Injury Science was founded in 1999 and conducts research to improve trauma care. The mission of CIS is to promote injury prevention and to improve outcomes from injury at all stages of care, from the prehospital setting through to resuscitation, acute care and rehabilitation. Clinicians from many specialties — including trauma surgeons, emergency medicine physicians, anesthesiologists, intensivists and rehabilitation specialists — work closely with epidemiologists, basic scientists, biostatisticians, health economists, health psychologists and methodologists.

The center’s Clinical Trials Unit will support the execution of the TAP trial.