Hemostasis Clinical Trial Outcomes Working Group

9/23/19 – 9/24/19
Natcher Conference Center
Building 45 Bethesda MD, 20894

Hemostasis Clinical Trial Outcomes Working Group

The development and execution of clinical trials that evaluate hemostatic products are impeded by the lack of commonly accepted outcomes by the necessary funding and regulatory agencies. The establishment of clinically relevant outcomes that are widely accepted for patients in clinical trials evaluating hemostatic blood products and therapeutics will enhance the ability to perform high quality clinical trials.

The NHLBI is sponsoring a 2-day workshop on 23/24 September 2019 at the Natcher building on the NIH campus in Bethesda. The DoD will be participating to the organization. The goal of the workshop is to develop recommendations that will establish clinically relevant primary and secondary outcomes for human trials evaluating hemostatic blood products, therapeutics and management algorithm design that will be acknowledged by funding and regulatory agencies. Examples include bleeding scores, laboratory value change, blood utilization, amount of bleeding, and clinical outcomes such as organ failure or death or death from hemorrhage at multiple timepoints after bleeding occurs. Co-directors are members from NHLBI, DoD, and academic centers.

There will be 7 subgroups of subject matter experts in multiple clinical disciplines (trauma, obstetric/gynecology, oncology/transplantation, inherited disorders of hemostasis, surgical/extracorporeal devices, gastrointestinal, neurosurgical) with two co-leaders and 7-14 other expert members by subgroup.  Each subgroup will include neonatal/pediatric recommendations, and a statistician/epidemiologist (as needed). Subgroup members will discuss by teleconferences (at least 3) before the workshop and propose recommendations at the workshop. Final recommendations will be informed by all discussions including output from the breakout sessions organized on day 1 of the workshop.