Liver TransplantNCT04945135
Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of Transfusion, One-year Graft Survival and Mortality. Cohort Study,
An observational study of Liver Transplant, run by Hospital Clinic of Barcelona at 2 sites in Spain.
Trial summary
RBC requirement ein DBD and DCD liver transplants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant
- How many people
- 591 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jun 2019to 25 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing LT
Who may be able to join
- patients undergoing LT
Who cannot join
- acute liver failure
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital de Cruces
Bilbao
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona
About this study
Official title: Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of
RBC requirement ein DBD and DCD liver transplants
Read the detailed description
Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD).
Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.
- Conditions
- Liver Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| liver donors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
RBC transfusion
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jun 2019
- Primary completion1 Jan 2020
- Study completion25 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 591 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Annabel Blasi, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945135
- Sponsor's protocol ID
- HCB/2019/1160
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 30 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Donors After Circulatory Death and Brain Death: a Multicenter Study of
- ClinicalTrials.gov ID
- NCT04945135
- Acronym / sponsor ID
- HCB/2019/1160
- Conditions
- Liver Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 591 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 25 Jun 2021 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RBC requirement ein DBD and DCD liver transplants
Detailed description
Background: Controlled donation after cardiac circulatory death (cDCD) is accepted to expand the donor pool for liver transplantation (LT). However, transfusion requirements and perioperative outcomes should be elucidated. The aims of this multicentre study are to assess the red blood cell (RBC) transfusions, one-year graft and patient survival after LT with cDCD compared to donors after brain dead (DBD).
Methods: 591 LT patients conducted in ten centers during 2019 were reviewed. Thromboelastometry was used to manage coagulation and blood product transfusion in all centres. Normothermic regional perfusion was the standard technique for organ recovery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| liver donors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing LT
Key inclusion criteria (1 listed)
- patients undergoing LT
Key exclusion criteria (1 listed)
- acute liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RBC transfusion
Time frame: intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant, run by Hospital Clinic of Barcelona at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RBC transfusion (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.