The Importance of Randomized, Controlled Trials in the Care of Organ Donors

This NEJM editorial by Kiran K. Khush discusses the pivotal multicenter trial by Dhar et al., which tested intravenous thyroid hormone supplementation (levothyroxine) in 838 brain-dead, hemodynamically unstable donors. Despite prior retrospective data suggesting improved heart utilization and graft outcomes, the trial showed no significant difference in transplantation rate (54.9% vs. 53.2%), 30-day graft survival (97.4% vs. 95.5%), or donor cardiovascular metrics. Levothyroxine use was associated with more severe hypertension and tachycardia. Subgroup analyses (ejection fraction ≤50%, vasopressor-inotrope score >10) also showed no benefit. The editorial emphasizes the study’s methodological rigor and highlights systemic barriers to donor-based randomized trials: lack of IRB oversight, funding, infrastructure, and standardization. Nearly half of U.S. organ-procurement organizations (OPOs) routinely use thyroid hormone therapy despite absence of benefit underscoring the importance of definitive trials to reshape clinical practice and increase organ yield.

This NEJM editorial by Kiran K. Khush discusses the pivotal multicenter trial by Dhar et al., which tested intravenous thyroid hormone supplementation (levothyroxine) in 838 brain-dead, hemodynamically unstable donors. Despite prior retrospective data suggesting improved heart utilization and graft outcomes, the trial showed no significant difference in transplantation rate (54.9% vs. 53.2%), 30-day graft survival (97.4% vs. 95.5%), or donor cardiovascular metrics. Levothyroxine use was associated with more severe hypertension and tachycardia. Subgroup analyses (ejection fraction ≤50%, vasopressor-inotrope score >10) also showed no benefit. The editorial emphasizes the study’s methodological rigor and highlights systemic barriers to donor-based randomized trials: lack of IRB oversight, funding, infrastructure, and standardization. Nearly half of U.S. organ-procurement organizations (OPOs) routinely use thyroid hormone therapy despite absence of benefit underscoring the importance of definitive trials to reshape clinical practice and increase organ yield.