Transplant Trial Watch

A Randomized Trial of Intravenous Thyroxine for Brain-Dead Organ Donors With Impaired Cardiac Function.

Dhar, R. et al.

Progress in Transplantation [record in progress].


Aims
The primary objective of this pilot study was to examine if cardiac function in brain dead (BD) donors exhibiting impaired ejection fraction (EF) could be improved by the infusion of thyroxine (T4).

Interventions
Donors were randomly assigned to either the T4 group or the placebo group.

Participants
28 brain-dead organ donors from 18 to 50 years of age were included in the study.

Outcomes
The primary outcome included improvements in the left ventricular ejection fraction (LVEF) with thyroxine infusion versus no treatment, evaluated using thoracic echocardiogram (TTE) immediately after infusion. The secondary outcome was the porportion of successfully transplanted hearts.

Follow-up
2.5 years

CET Conclusions
This small study from a single organ procurement organization in the US investigated the use of thyroxine in the management of DBD donors with an ejection fraction less than 60%. In the 28 potential donors randomized to T4 or control, no changes were seen in ejection fraction or donation rates between the groups. The study is limited by its small size – of the 28 patients recruited, around 40% did not receive the full treatment with T4 or undergo repeat echo. The lack of power means that no firm conclusion can be made. However, it does nicely demonstrate feasibility, as well as the challenges to recruitment in a study such as this. Ultimately a larger, definitive study is still needed.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
N/A

Funding source
No funding received