UAB’s Center for Injury Science (CIS) Director Jan Jansen, MBBS, Ph.D., Executive Director Shannon Stephens, EMTP, and senior scientist John Holcomb, M.D., were featured in the 2nd Annual (Trauma and Prothrombin Complex Concentrate) TAP Investigators Meeting held September 18-19 in Newport Beach, California.
The Trauma and Prothrombin Complex Concentrate (TAP) Clinical Trial is sponsored by CSL Behring, a global biotechnology leader, and will determine whether Kcentra® / Beriplex®, a Prothrombin Complex Concentrate (PCC), reduces mortality in trauma patients with acute major bleeding who are predicted to require large volume blood transfusions by promoting clotting and slowing bleeding.
It is the largest centrally conducted Exception from Informed Consent (EFIC) trial in U.S. history.
At the meeting, Jansen discussed the first year’s progression of the study, explaining the guiding principles for TAP, as well as inclusion and exclusion for the trial. Jansen also spearheaded a panel discussion involving patient enrollment.
Stephens presented on EFIC progress and learnings throughout year one of the TAP Trial. Shannon also explained the elements of the EFIC plan which includes a social media campaign, local surveys (which average about 300 completed surveys per institution), and local community meetings that are led by the institution’s principal investigator using a dedicated slide set.
The community meetings, which take place in an online forum format, average about 35 attendees. The objective of these meetings is to discuss what the TAP trial is to members of the community who would fall in the catchment area of the institutions. Year-to-date, there are 92 institutions in network and 75 institutions whose campaigns are live.
UAB, recognized as a leader in hosting these unique social media-based community consultations for multi-center trials, is now responsible for running seven trials nationwide, representing 178 institutions.
Holcomb was featured in Jansen’s patient enrollment discussion. Holcomb also participated in a Q and A session along with other elite trauma surgeons.
“Overall, I am extremely pleased with the progress we have made with this prestigious and life-saving study,” Jansen said. “I am looking forward to the progress that we will make in year two.”
The group representing UAB included:
- Jan Jansen, MBBS, Ph.D., FRCS
- Shannon Stephens, EMTP, CCEMTP
- John Holcomb, M.D., FACS
- Joel Rodgers
- Emily Turner
- Christy Ledbetter
- Sarah Duckert
- Tanner Coffman
About the Center for Injury Science
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.