Organ TransplantNCT05194306
PERTRIAL - Perla® Preservation Solution
A study testing Perla® Cold Preservation solution in people with Organ Transplant and Ischemic Reperfusion Injury, run by Advanced Life Solutions at 1 site in Spain.
Trial summary
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient. The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplant, Ischemic Reperfusion Injury
- What is being tested?
- Perla® Cold Preservation solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteSpain
- Study dates
- 11 Dec 2021to 30 Apr 2022
- Phase
- Interventional
- 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
Who may be able to join
- Donor kidney / liver suitable for preservation
- Donor age equal or over 18 years old
- Donor meets one of the following conditions:
- Donor after brain death (DBD), standard and extended criteria (SCD \& ECD)
- Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
- Patient registered primary kidney or liver transplant candidate, male or female
- Patient ages ≥ 18 years old
- Patient who has signed written informed consent
Who cannot join
- Donor participating at the same time in another Clinical Investigation
- Recipient eligibility criteria:
- Patient recipient will not be included if any of the following conditions exists:
- Prior solid organ or bone marrow transplant
- Multi-organ transplant
- Contraindications to transplantation (Active infection, active malignancy, pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method)
- Participation in another clinical trial
- Patient unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Performance of Perla® Preservation Solution for Donor Liver and Kidney for Transplantation
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.
- Conditions
- Organ Transplant, Ischemic Reperfusion Injury
- Being tested
- Perla® Cold Preservation solution
- Keywords
- Cold Preservation Solution, Ischemic Reperfusion Injury, Organ Transplant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perla® Cold Preservation solutionDrug
Perla® must be cooled to 2° to 6 °C prior to use. The cold Preservation Solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation.
| Study group | Role | What they receive |
|---|---|---|
| Perla® Cold Preservation solution | Experimental | Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient. Receives: Drug: Perla® Cold Preservation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft Function Rate (Kidney & Liver)
Measured: 7 days post transplant
Secondary outcomes (9)
Graft survival (Kidney & Liver)
Measured: 7 days post-transplant
Graft survival (Kidney & Liver)
Measured: 14 & 30 days post-transplant
Rate of an event or serious adverse device effects (Kidney & Liver)
Measured: within 30 days post-transplant
Evaluation of patient anxiety (Kidney & Liver)
The patient will complete the HAD scale ("Hospital Anxiety and Depression Scale") after signing his/her consent before the transplant.
Measured: pre-transplant
Duration of delayed graft function (Kidney)
Measured: within 30 days post-transplant
Rate of functional delayed graft function (f-DGF) (Kidney)
Measured: within 7 days post-transplant
Daily serum creatinine (Kidney)
Measured: 7 days post-transplant, or until the patient is discharged - whichever is earliest
Peak level of serum AST (Liver)
Measured: within 7 days post-transplant
Post-reperfusion syndrome (Liver)
Measured: during operative procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start11 Dec 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ TransplantStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Life Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Complexo Hospitalario Universitario de A Coruña
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194306
- Sponsor's protocol ID
- CIP001A
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Performance of Perla® Preservation Solution for Donor Liver and Kidney for Transplantation
- ClinicalTrials.gov ID
- NCT05194306
- Acronym / sponsor ID
- CIP001A
- Conditions
- Organ Transplant, Ischemic Reperfusion Injury
- Keywords
- Cold Preservation Solution, Ischemic Reperfusion Injury, Organ Transplant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Advanced Life SolutionsIndustry (pharma, biotech, devices)
- Collaborators
- Complexo Hospitalario Universitario de A Coruña
- Study start
- 11 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 18 Jan 2022 (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.
Perla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient.
The purpose of the PERTRIAL clinical investigation is to demonstrate the Performance and Safety of Perla® Cold Preservation solution.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perla® Cold Preservation solution | Experimental | Drug: Perla® Cold Preservation solutionPerla® is a Cold Preservation Solution, with purpose to wash out, preserve during transport liver and kidney grafts in optimal conditions from the donor to the recipient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Donor kidney / liver suitable for preservation
- Donor age equal or over 18 years old
- Donor meets one of the following conditions:
- Donor after brain death (DBD), standard and extended criteria (SCD \& ECD)
- Donor after circulatory death (DCD), cardiac arrest Maastricht classification III (awaiting cardiac arrest, controlled)
Key exclusion criteria (8 listed)
- Donor participating at the same time in another Clinical Investigation
- Prior solid organ or bone marrow transplant
- Multi-organ transplant
- Contraindications to transplantation (Active infection, active malignancy, pregnant females, females intending to get pregnant, or not willing to use a secure contraceptive method)
- Participation in another clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perla® Cold Preservation solutionPerla® must be cooled to 2° to 6 °C prior to use. The cold Preservation Solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation. | Drug | Perla® Cold Preservation solution |
Primary outcome
Graft Function Rate (Kidney & Liver)
Time frame: 7 days post transplant
9 secondary outcomes
Graft survival (Kidney & Liver)
Time frame: 7 days post-transplant
Graft survival (Kidney & Liver)
Time frame: 14 & 30 days post-transplant
Rate of an event or serious adverse device effects (Kidney & Liver)
Time frame: within 30 days post-transplant
Evaluation of patient anxiety (Kidney & Liver)
Time frame: pre-transplant
Duration of delayed graft function (Kidney)
Time frame: within 30 days post-transplant
Rate of functional delayed graft function (f-DGF) (Kidney)
Time frame: within 7 days post-transplant
Daily serum creatinine (Kidney)
Time frame: 7 days post-transplant, or until the patient is discharged - whichever is earliest
Peak level of serum AST (Liver)
Time frame: within 7 days post-transplant
Post-reperfusion syndrome (Liver)
Time frame: during operative procedure
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 17 May 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perla® Cold Preservation solution in people with Organ Transplant and Ischemic Reperfusion Injury, run by Advanced Life Solutions at 1 site 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 8 inclusion and 8 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 17 May 2023. 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 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?
Graft Function Rate (Kidney & Liver) (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 17 May 2023; AzTrials last refreshed its copy on 26 Oct 2026.