ABA – Multicenter Trials Group
Town Hall Meeting
ABA 42nd Annual Meeting
Boston, MA
March 10, 2010

Welcome and Call To Order (Jeffrey Saffle)

Overview of MCTG Organizational Structure (J. Saffle, MB Lawless, M Peck)

• Please review the MCTG organizational structure, bylaws and policies and procedures at http://www.ameriburn.org/research.php
• The MCTG Data Coordinating Center has been established at the University of California Davis. Mary Beth Lawless is the MCTG Director of Clinical Operations (DROP). Positions for three informatics professionals have been posted. The MCTG has hired one RN (Katrina Falwell) and one clinical data specialist (Terese Curri) to work with Ms. Lawless.
• Dr. Mike Peck has established a MCTG Data Safety and Monitoring Board (DSMB) to monitor MCTG related studies. Members include: Ravindra Mehta, MD (Chair), James Alden, PhD (statistician), and Sharmila Dissanaike, MD. DSMB policies and procedures have been developed.

Progress Reports (J Saffle)

• Boxer 1 Grant - Evaluation of military and civilian outcomes after burn injury: a multicenter trial
• PI: Tina Palmieri
• Funding Amount: $2,036,000
• Funding Period: 10/09-9/12
• Update: Local IRB approval obtained. DOD IRB approval pending. This grant will build models to predict mortality using the NBR. The resulting NBR dataset will be available to ABA investigators through the National Burn Repository Committee.

• Clinical trial of blood transfusion triggers in adult burn patients
• PI: Tina Palmieri
• Funding Amount: $2,300,000
• Funding Period: 10/09-9/11
• Update: 13 centers are participating to enroll 400 patients; but more sites would be considered. UC Davis is recruiting patients. Other sites are in the IRB process.

• Burn patient acuity, demographics, scar contractures and rehabilitation treatment time in relation to patient outcomes
• PI: Reg Richard
• Funding Amount: $2,100,000
• Funding Period: 9/08-10/12
• Update: 17 participating sites. DOD IRB approved; awaiting local IRB approvals. All sites will be trained within the next quarter. A web-based CRF has been developed and will incorporate the SAGE diagram.

• Multicenter trials in burns to improve combat casualties
• PI: Jeffrey Saffle
• Funding Amount: $7,990,000
• Funding Period: 10/09-9/13
• Update: Five independent proposals from MCTG members were accepted for this grant.
1. ABA Rescue Trial
   PI: Kevin Chung
   This study will look at the association of high volume ultrafiltration on survival in burn patients with septic shock and acute renal failure. 11 sites will enroll 120 subjects over 4 years. Each site will be awarded $25,000 for start-up costs and $8,000 per subject. The IRB is approved and contracting with sites is under way. If interested in participating, please contact Kevin Chung (Kevin.Chung@amedd.army.mil) or Elsa Coats (Elsa.Coats@amedd.army.mil).


2. Rapid quantitative PCR-based detection of Staph aureus in burn sepsis patients
   PI: Nam Tram
   Four centers are participating in this trial. Local IRB approval has been obtained and the IRB is ready to be submitted to the DOD.


3. Effects of a community-based exercise program in adults with severe burns
   PI: Oscar Suman
   This study will be conducted at two sites. Awaiting DOD IRB.


4. Effects of enteral glutamine supplementation on mortality and infectious morbidity in severely burned patients: a multicenter trial.
   PI: Paul Wischmeyer, Dominique Garrel
   Nine centers will be participating, five in the US.


5. Development of an inhalation injury scoring system to predict severity of inhalation injury
   PI: Kevin Foster
   Six centers are participating. IRB approved. CRF’s and contracts with sites are under development.

• Proposed Project: Boxer II
• Evaluation of outcomes after burn injury
• PI: Tina Palmieri
• Funding Amount: $4,000,000
• Update: A full proposal was submitted in 10/09. This project will be: a) continued data mining of the NBR in combination with other databases to evaluate consequences of combined burn and traumatic injury, and b) $1,000,000 for investigator initiated projects

• Proposed Project: Boxer III
  • Military burn-trauma research program
  • PI: To be determined
  • Update: This study will be $4 – 8,000,000 to fund 1-3 investigator initiated clinical trials. A preproposal will be submitted to the DOD in spring 2010. A request for individual proposals will be announced to MCTG members in March/April 2010.

Proposals from the MCTG Membership At Large

• IV-Ig – Drs. Cochran and Cartotto
  Dr. Cochran presented an update on the development of a randomized clinical trial of IV-Ig in the treatment of TEN. They will be applying for FDA orphan disease funding to develop an intent to treat trial at 6-10 burn centers. Approximately 50 adult patients will be enrolled over a 3 year period. Contact Dr. Amalia Cochran for more information (Amalia.cochran@hsc.utah.edu).


• Potential for future NIH funding for burn clinical trials – Dr. Bruce Cairns
  NIH is expressing more interest in funding clinical research, which may be of future interest and benefit to members of the MCTG. Contact Dr. Bruce Cairns for more information (bruce_cairns@med.unc.edu).

MCTG Steering Committee Elections

• Two MCTG steering committee positions are open. Dan Caruso has resigned and Linda Edelman’s term is completed.  One position must be filled by a non-MD.
• Linda Edelman was nominated by the Steering Committee for re-election to the non-physician position.
• Two individuals, James Holmes and Tam Pham were nominated for the open position. James Holmes was nominated by the Steering Committee. Tam Pham was nominated by Matthew Klein. Bruce Cairns was nominated by Warren Garner but Dr. Cairns declined to accept the nomination.
• Each candidate will submit a 150 word biographical sketch to Dr. Saffle. Sketches will be posted on the website. Elections will be held electronically. All ABA members are eligible to vote.

Submitted by Linda S. Edelman 3/15/10
Linda.edelman@nurs.utah.edu