The Center for Injury Science (CIS) at UAB has partnered with CSL Behring to support the management of one of the largest ever trauma clinical trials.
The Trauma and Prothrombin Complex Concentrate (TAP) Clinical Trial will determine whether Prothrombin Complex Concentrate (PCC, also known as Kcentra® / Beriplex®) reduces mortality in trauma patients who are predicted to require large volume blood transfusions.
The trial’s overall lead will be Jan Jansen, MBBS, Ph.D., FRCS, the 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., FACS, also a professor in the division and CIS senior scientist, will be the co-lead. Shannon Stephens, CCEMTP, executive director of CIS, will be the program manager.
CSL Behring, a global biotherapeutics leader which makes PCC, is sponsoring the TAP trial with collaboration from UAB's CIS.
Hemorrhage is the most common cause of preventable death after injury, and trauma patients who have impaired blood clotting are five times more likely to die.
PCC is currently used to reverse the effects of anticoagulant medications, such as warfarin, in patients with major bleeding or who urgently need surgery.
This trial will demonstrate whether trauma patients who are not taking anticoagulants could also benefit from PCC’s ability to promote clotting and slow bleeding.
If shown to be affective, treatment with PCC could transform the standard of care for bleeding trauma patients and save thousands of lives.
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 can’t give informed consent, the trial will be an Exception-From-Informed-Consent (EFIC) trial. CIS will meet federal regulations by using social media-based, innovative methods pioneered by Stephens for educating and engaging with communities across the United States. UAB is the only institution in the U.S. to have led interactive, social 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.