Hemostasis Clinical Trial Outcomes Working Group

Develop recommendations that will establish CLINICALLY RELEVANT PRIMARY AND SECONDARY OUTCOMES FOR CLINICAL TRIALS The goal of this state of the science workshop is for experts in hemostasis to develop recommendations that will establish clinically relevant, primary and secondary outcomes for clinical trials evaluating hemostatic blood products, therapeutics, and management algorithm design. Points of discussion will include; bleeding scores, laboratory value change, blood utilization, amount of bleeding, and clinical outcomes such as organ failure or death or death from hemorrhage. The ultimate objective of this workshop is to provide recommendations to the NHLBI, as a consensus on primary and secondary outcomes to consider in hemostasis clinical trials. HEMOSTASIS OUTCOMES FOR CLINICAL TRIALS WORKSHOP AGENDA (DRAFT) MONDAY, SEPTEMBER 23RD 9:00 am - 9:15 am Opening Remarks from NHLBI Leadership 9:15 am - 9:30 am Introduction to the workshop: Dr. Phil Spinella SESSION 1- CURRENT STATUS ---MODERATOR: DR. PHIL SPINELLA 9:30 am - 9:50 am Exception from Informed Consent in Emergency Use Settings: Dr. Salim Hadad 9:50 am - 10:10 am Current status and limitations on hemostasis trials in cardiac surgery: Dr. Jerry Levy 10:10 am - 10:30 am Current status and limitations on hemostasis in trauma trials: Dr. John Holcomb BREAK 10:30 am - 10:50 am SESSION 2- DESIGN CONSIDERATIONS ---MODERATOR: DR. MARIE STEINER 10:50 am - 11:25 am Definitions and scores in bleeding: lessons from platelet trials: Dr. Simon Stanworth 11:15 am - 11:40 am Clinical trial inclusion criteria: bleeding severity vs. disease category: Dr. Andre Cap 11:40 am - 12:05 pm Adaptive Design and Innovative Statistical Modeling: Dr. Roger Lewis PANEL DISCUSSION- SESSION 1 AND SESSION 2 12:05 pm - 12:20 pm Moderator: Dr. Nahed El Kassar LUNCH 12:20 pm - 1:30 pm Lunch on your own BREAKOUT SESSIONS 1:30 pm - 3:00 pm Breakout Sessions A for subgroups to refine proposals Group 1: Traumatic bleeding (Room TBD) Group Leaders: Dr. John Holcomb & Dr. Gene Moore Group 3: Obstetric/Gynecologic bleeding (Room TBD) Group Leaders: Dr. Michael Paidas & Dr. Andra James Group 5: Inherited bleeding disorders (Room TBD) Group Leaders: Dr. Nigel Key & Dr. Guy Young Group 6: Gastrointestinal bleeding (Room TBD) Group Leaders: Dr. Dennis Jenson & Dr. Alan Barkun BREAK 3:00 pm - 3:30 pm 3:30 pm – 5:00 pm Breakout Sessions B Group 4: Oncologic bleeding (Room TBD) Group Leaders: Dr. Simon Stanworth & Dr. Terry Gernsheimer Group 2: Surgical and extracorporeal bleeding (Room TBD) Group Leaders: Dr. Jerrold Levy & Dr. Christopher Almond Group 7: Neurosurgical bleeding (Room TBD) Group Leaders: Dr. Joshua Goldstein & Dr. Stephen Mayer HEMOSTASIS OUTCOMES FOR CLINICAL TRIALS WORKSHOP AGENDA (DRAFT) TUESDAY, SEPTEMBER 24TH , 2019 8:00 am - 8:10 am Introduction and plans for the day- Dr. Marie Steiner RECOMMENDATIONS FROM BREAKOUT GROUPS 8:10 am - 10:20 am Group 1: Traumatic bleeding (8:10 am - 8:30 am) Group 2: Surgical and Extracorporeal bleeding (8:30 am - 8:50 am) Group 3: Obstetric/Gynecologic bleeding (8:50 am – 9:10 am) Group 4: Oncologic bleeding (9:10 am – 9:30 am) Group 5: Inherited bleeding disorders (9:30 am - 9:50 am) Group 6: Gastrointestinal bleeding (9:50 am - 10:10 am) Group 7: Neurosurgical bleeding (10:10 am – 10:30 am) 10:30 am - 10:45 am Break PANEL DISCUSSIONS FOR BREAKOUT GROUPS 10:45 am - 11:30 am Moderators: Dr. Andre Cap SUMMARY/CONCLUSION 11:30 am - 12:00 pm Dr. Ian Roberts