Active Trials

LITES: Prehospital Airway Control Trial (PACT)

  • Principal Investigator: Juan Duchesne, M.D.
  • Sponsor: Department of Defense (DOD)
  • Description: Open label, multi-center, stepped wedge randomized trial comparing a standard airway management strategy and a strategy of initial use of SGA for airway management of prehospital trauma patients. The objective of this study is to compare the effect of a standard strategy of airway management vs. a strategy of first attempt with supraglottic airway (SGA) upon 24-hour survival after traumatic injury.

Upcoming Trials

Trauma Resuscitation with Group O Whole Blood or Products (TROOP)

  • Principal Investigator: Juan Duchesne, M.D.
  • Sponsor: National Institutes of Health (NIH)
  • Description: A pragmatic, multi-center, Bayesian, group-sequential, combined non inferiority/superiority, randomized clinical trial. The trial will include injured patients with hemorrhagic shock anticipated to require massive blood transfusions, who will be randomized to receive either whole blood (at least 8 units, if there is an ongoing transfusion requirement) or only component therapy. The primary outcome is mortality at 6 hours. The secondary endpoints are 24 hour mortality, 30-day/hospital mortality (whichever the earlier), complications.

 

A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Large Simple Trial Evaluating the Use of BE1116 (4-Factor Prothrombin Complex Concentrate [Kcentra® / Beriplex®]) to Improve Survival in Patients with Traumatic Injury and Acute Major Bleeding

  • Principal Investigator: Juan Duchesne, M.D.
  • Sponsor: CSL Behring
  • Description: This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have traumatic injury, with confirmed or suspected acute major bleeding and/or predicted to receive a large volume blood product transfusion. The primary endpoint is all-cause mortality within 6 hours after randomization. The secondary endpoints are all-cause in-hospital mortality up to 24 hours after randomization, then all-cause in-hospital mortality up to 30 days after randomization.

 

For additional information on our Trauma Clinical Trials please call Danjuma Bello at (504) 988-5272.