HIV Management: Clinical Case Conundrums – A Wheel of Knowledge Challenge!
HIV Management: Clinical Case Conundrums – A Wheel of Knowledge Challenge!
Thu, Oct 20, 6:30 PM
Marriott Marquis Washington, DC • Washington, DC
Free
Actions Panel
Hemostasis Clinical Trial Outcomes Workshop
Develop recommendations that will establish clinically relevant primary and secondary outcomes for clinical trials
When and where
Date and time
Location
NIH Building 45 45 Center Drive Bethesda, MD 20894
Map and directions
How to get there
About this event
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 Haddad
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. Alfonso Iorio
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 Leader: Dr. Jerrold Levy
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