Delayed Graft FunctionHMPNCT04359173
Propensity Score Matched Comparison of HMP vs. SCS in Kidney Transplantation
An observational study of Delayed Graft Function, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
Hypothermic machine perfusion (HMP) is considered superior to static cold storage (SCS) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delayed Graft Function
- How many people
- 347 participants
- Where
- 1 siteAustria
- Study dates
- 1 Aug 2015to 30 Mar 2020
- 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: All deceased donor kidney transplants performed between 08/2015 and 12/2019
Who may be able to join
- single kidney transplantation from a deceased donor at Medical University of Innsbruck between 08/2015 and 12/2019
Who cannot join
- combined kidney transplantation with an other organ
- living donor kidney transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Propensity Score Matched Analysis Reveals Superiority of Hypothermic Machine Perfusion Over Static Cold Storage in Deceased Donor Kidney Transplantation.
Hypothermic machine perfusion (HMP) is considered superior to static cold storage (SCS) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood.
The aim of our study is to investigate the real-world impact of HMP on kidney graft function after deceased donor kidney transplant in an HMP cohort propensity score matched with SCS.
Propensity score matching will be based on CIT, ECD, gender mismatch, CMV mismatch, re-TX and ET-senior program with a caliper of 0.05
- Conditions
- Delayed Graft Function
- Keywords
- kidney transplantation
- Medical subject headings
- Delayed Graft Function
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 |
|---|---|---|
| Hypothermic machine perfusion (HMP) | patients who underwent kidney transplantation following HMP | |
| Static cold storage (SCS) | patients who underwent kidney transplantation following SCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delayed graft function (DGF)
DGF was defined as the need for at least one dialysis within the first seven days after transplant with the exception of dialysis for hyperkalemia or hypervolemia within the first 12 hours post-transplant
Measured: 7 days post transplant
Secondary outcomes (1)
graft survival
24 month graft survival
Measured: 24 months post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Aug 2015
- Primary completion31 Dec 2019
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delayed Graft FunctionStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Schneeberger, Prof., Principal investigator, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04359173
- Sponsor's protocol ID
- HMP_SCS
- Acronym
- HMP
- Status last verified
- Apr 2020
- First submitted
- 20 Apr 2020
- Last updated
- 24 Apr 2020
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Propensity Score Matched Analysis Reveals Superiority of Hypothermic Machine Perfusion Over Static Cold Storage in Deceased Donor Kidney Transplantation.
- ClinicalTrials.gov ID
- NCT04359173
- Acronym / sponsor ID
- HMP / HMP_SCS
- Conditions
- Delayed Graft Function
- Keywords
- kidney transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 24 Apr 2020 (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.
Hypothermic machine perfusion (HMP) is considered superior to static cold storage (SCS) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood.
The aim of our study is to investigate the real-world impact of HMP on kidney graft function after deceased donor kidney transplant in an HMP cohort propensity score matched with SCS.
Propensity score matching will be based on CIT, ECD, gender mismatch, CMV mismatch, re-TX and ET-senior program with a caliper of 0.05
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermic machine perfusion (HMP) | – | –patients who underwent kidney transplantation following HMP |
| Static cold storage (SCS) | – | –patients who underwent kidney transplantation following SCS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All deceased donor kidney transplants performed between 08/2015 and 12/2019
Key inclusion criteria (1 listed)
- single kidney transplantation from a deceased donor at Medical University of Innsbruck between 08/2015 and 12/2019
Key exclusion criteria (2 listed)
- combined kidney transplantation with an other organ
- living donor kidney transplantation
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
Delayed graft function (DGF)
Time frame: 7 days post transplant
DGF was defined as the need for at least one dialysis within the first seven days after transplant with the exception of dialysis for hyperkalemia or hypervolemia within the first 12 hours post-transplant
1 secondary outcome
graft survival
Time frame: 24 months post transplant
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 24 Apr 2020.
- Individual participant dataSharing planned: No
Related trials for Delayed Graft Function
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
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Enrolling by invitation
Feasibility of Physical Prehabilitation for High-Risk Patients Undergoing Cardiac Surgery Via Sternotomy
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Active, not recruitingPhase 2
ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function
Delayed Graft Function
Not yet recruiting
Drone Transport of Deceased-Donor Kidney Grafts Between Two French Hospitals Before Transplantation: a Pilot Safety Study
Kidney Failure, Chronic, Kidney Transplantation
Recruiting
The Impact of Intraoperative Diuretic Use on Delayed Graft Function Following Deceased Donor Renal Transplantation
Delayed Graft Function, Kidney Transplantation
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.
Stefan Schneeberger, Prof. principal investigator
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delayed Graft Function, run by Medical University Innsbruck at 1 site in Austria.
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 2 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 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Delayed graft function (DGF) (time frame: 7 days post transplant). 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 24 Apr 2020.