AllograftREACIMALLOGVNCT05096351
Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
An observational study of Allograft and Cold Temperature, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allograft, Cold Temperature, Saphenous Vein
- What is being tested?
- Blood test
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2022to Dec 2025
- 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 receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material.
Who may be able to join
- The patient must be a member or beneficiary of a health insurance plan
- Patients receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material.
Who cannot join
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject has already been included in the study
- The subject refuses to participate
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient previously having received a venous allograft or organ transplant
- Pregnant, parturient or breastfeeding patients
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Nîmes
Nîmes
Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr
Elsa Faure
About this study
The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients.
The aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the BIOPROTEC method. In case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.
- Conditions
- Allograft, Cold Temperature, Saphenous Vein
- Being tested
- Blood test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testOther
Collection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies
| Study group | Role | What they receive |
|---|---|---|
| Patients with venous allograft | Not described Receives: Other: Blood test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of donor specific antibodies after venous allograft
Presence/absence of donner anti-HLA antibodies in patient blood, detected using Luminex assay
Measured: 1 month
Secondary outcomes (2)
Allograft anomalies linked to allograft rejection
Inflammation, thrombosis, aneurysms progression
Measured: 1 month
Allograft anomalies linked to allograft rejection
Inflammation, thrombosis, aneurysms progression
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start8 Jun 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllograftStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elsa Faure, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096351
- Sponsor's protocol ID
- LOCAL/2021/EF-01
- Acronym
- REACIMALLOGV
- Status last verified
- May 2024
- First submitted
- 15 Oct 2021
- Last updated
- 6 May 2024
- 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 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Reaction of the Recipient After Cold-stored Saphenous Venous Allograft (Bioprotec)
- ClinicalTrials.gov ID
- NCT05096351
- Acronym / sponsor ID
- REACIMALLOGV / LOCAL/2021/EF-01
- Conditions
- Allograft, Cold Temperature, Saphenous Vein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 8 Jun 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 27 Oct 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.
The study investigators propose to perform a blood test before and after allograft placement in all patients receiving a cold-stored venous allografts at the University Hospital of Nîmes to study the occurrence of FVFA-related ASD in these patients.
The aim of this work is to characterize a possible immune reaction generated by the implantation of venous allografts prepared according to the BIOPROTEC method. In case of a proven immune reaction, the study will allow a modification of our current attitude and to exclude patients potentially eligible for renal transplantation at the time of venous allograft placement, or to perform in these patients an allo-compatibility test with the venous allograft preoperatively and thus protect these patients from an increased risk of subsequent organ transplant rejection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with venous allograft | – | Other: Blood test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material.
Key inclusion criteria (2 listed)
- The patient must be a member or beneficiary of a health insurance plan
- Patients receiving a scheduled venous allograft within the CHU of Nîmes for an arterial bypass in the lower limb or an arteriovenous bypass in the upper limb within the framework of the creation of arteriovenous fistulas in dialysis patients, in the absence of available autologous venous material.
Key exclusion criteria (7 listed)
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject has already been included in the study
- The subject refuses to participate
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
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 |
|---|---|---|
| Blood testCollection of blood samples at 1 and 6 months for HLA typing for donor and recipient antibodies | Other | Patients with venous allograft |
Primary outcome
Presence of donor specific antibodies after venous allograft
Time frame: 1 month
Presence/absence of donner anti-HLA antibodies in patient blood, detected using Luminex assay
2 secondary outcomes
Allograft anomalies linked to allograft rejection
Time frame: 1 month
Allograft anomalies linked to allograft rejection
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
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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.
Elsa Faure principal investigator
CHU Nimes
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 Allograft and Cold Temperature, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 6 May 2024. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsa Faure (04.66.68.39.30, elsa.faure@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of donor specific antibodies after venous allograft (time frame: 1 month). 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 6 May 2024.