- ClinicalTrials.gov ID: NCT05405426
- Recruiting participants (Starts Jan. 3, 2023)
- Not accepting healthy volunteers
- UTSW Principal Investigator: SIRINE BALTAGI
summary
SPECIFIC AIM 1: To test whether children < 6 years of age on ECMO randomized to a strategy of indication-based versus center-specific threshold-based RBC transfusion will have greater improvement in organ function, as measured by change in the Pediatric Sequential Organ Failure Score (pSOFA). SPECIFIC AIM 2: To test whether children < 6 of age on ECMO randomized to indication-based compared to center-specific threshold-based RBC transfusion will have better outcomes of neurodevelopment, function, and health-related quality of life measured at 1-year post-randomization.
objective
OVERALL AIM of this research is to conduct a multicenter randomized clinical trial to determine if indication-based red blood cell (RBC) transfusion based on reduced tissue oxygen delivery, compared with RBC transfusion based on an institutional-specific threshold reduces organ dysfunction and improves neurodevelopment, function, and health-related quality of life in critically ill infants and children receiving extracorporeal membrane oxygenation (ECMO).