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