Does melatonin improve the organ donation process?
| ISRCTN | ISRCTN66157570 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66157570 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | AP166562017 |
| Sponsor | Fundación Mutua Madrileña |
| Funder | Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla |
- Submission date
- 29/09/2021
- Registration date
- 30/09/2021
- Last edited
- 30/05/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Controlled donation after circulatory death (cDCD) and donation after brain death (DBD) have allowed the transplant community to safely increase the organ donor pool. However, it is not without its risky complications, due to cell damage from lack of oxygen to the tissues (hypoxia). Different strategies have been developed to diminish the toxic effects of oxidative stress, but the search for preventive measures and modulation remains a high priority. Melatonin, a molecule that is easy to administer and harmless to the body, has been shown to have antioxidant properties that reduce oxidative stress.
The present work quantifies the oxidative stress and miRNA activation occurring in DCD and DBD donors, and assesses its modulation after melatonin administration.
Who can participate?
Donors are aged 18 years or above, and suffered from circulatory or brain death
What does the study involve?
Participants will be randomly allocated to receive melatonin or placebo immediately after death.
What are the possible benefits and risks of participating?
None
Where is the study run from?
Virgen del Rocio University Hospital (Spain)
When is the study starting and how long is it expected to run for?
December 2017 to November 2021
Who is funding the study?
Fundación Pública Andaluza para la Gestión de la Investigación en Salud de Sevilla (Spain)
Who is the main contact?
Dr Egea-Guerrero, jjegeaguerrero@gmail.com
Contact information
Scientific
Virgen del Rocio University Hospital
Avda. Manuel Siurot s/n
Sevilla
41013
Spain
 ORCID ID |
0000-0002-4166-313X |
|---|---|
| Phone | +34 686638646 |
| juanj.egea.sspa@juntadeandalucia.es |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized multicenter triple-blind clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Role of melatonin as a therapeutic strategy against tissue ischemia in the cadaveric donor and its assessment using oxidative stress biomarkers and microRNAs |
| Study objectives | The administration of melatonin in the cadaveric donor prior to organ harvesting will alleviate the ischemic damage that occurs from donor extubation to preservation of the graft, and therefore will improve the functionality of the organs after transplantation, and consequently survival of the graft in the recipient. Melatonin will modulate oxidative stress cascades, both at the protein and / or enzyme level (MDA, carbonylated proteins, etc.) and at the miRNA level. |
| Ethics approval(s) | Approved 03/12/2018, CEI de los hospitales universitarios Vírgen Macarena-Virgen del Rocío (Avda. Manuel Siurot s/n, Seville, Spain; +34 600 16 24 58; administracion.eecc.hvm.sspa@juntadeandalucia.es), ref: 1013-N17 |
| Health condition(s) or problem(s) studied | 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. |
| Intervention | 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 in 20 ml of sucrose solution (0.4 g/dl). Controls received 20 ml of diluted sucrose solution. Randomization was generated by an electronic system (N-Qery advisor). |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Melatonin |
| Primary outcome measure(s) |
1. Number of valid organs for donation per donor using hospital records |
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 30/11/2021 |
Eligibility
| Participant type(s) | Other |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 53 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/03/2018 |
| Date of final enrolment | 15/02/2020 |
Locations
Countries of recruitment
- Spain
Study participating centres
Seville
41013
Spain
Málaga
29010
Spain
Cádiz
11009
Spain
Granada
18014
Spain
Huelva
21005
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 20/04/2022 | 15/12/2022 | Yes | No | |
| Other publications | Using malondialdehyde (MDA) measurement to assess oxidative stress | 20/04/2022 | 20/04/2022 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | in Spanish | 30/09/2021 | No | No |
Additional files
- 40494 Protocol.pdf
- in Spanish
Editorial Notes
30/05/2022: Internal review.
20/04/2022: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been changed from 60 to 53.
30/09/2021: Trial's existence confirmed by CEI de los hospitales universitarios Vírgen Macarena-Virgen del Rocío.
