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Does melatonin improve the organ donation process?

Role of melatonin as a therapeutic strategy against tissue ischemia in the cadaveric donor and its assessment using oxidative stress biomarkers and microRNAs

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN66157570
Enrollment
60
Registered
2021-09-30
Start date
2018-03-15
Completion date
Unknown
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The present work quantifies the oxidative stress and miRNAs occurring in controlled donation after circulatory death and donation after brain death, and assesses its modulation after melatonin administration. Not Applicable

Interventions

Melatonin or placebo was administered via nasogastric tube at the time of determination of death by either neurological or circulatory criteria. The melatonin group received 30 mg of melatonin diluted

Sponsors

Fundación Mutua Madrileña
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Potential donors after circulatory or brain death 2. Patient suitable for organ donation under Spain’s National Transplant Organization protocols 3. Age above 18 years

Exclusion criteria

Exclusion criteria: 1. Potential donors with multiorgan failure 2. Age below 17 years 3. Exclusion criteria for organ donation following Spain’s National Transplant Organization protocols

Design outcomes

Secondary

MeasureTime frame
There are no secondary outcome measures

Primary

MeasureTime frame
1. Number of valid organs for donation per donor using hospital records 2. Functionality of each organ at 6 and 12 months after transplant following hospital records

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026