Liver TransplantationNCT03094728
Role of Human Leukocyte Antigen Matching in Liver Transplantation and Its Relation to Outcomes
An observational study of Liver Transplantation, run by Ain Shams University.
Trial summary
The study aimed to assess HLA compatibility, HLA antibodies and cross matching in liver transplantation recipients and their relation to acute rejection, CMV infection, and recurrence of HCV. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- HLA cross matching
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Jun 2016
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients with end stage liver diseases potential candidates for living donor liver transplantation and their donors
Who may be able to join
- Recipient selection:
- Adult recipients who are candidate for LDLT due to HCV related ESLD and meeting the transplantation criteria of the Ain Shams Center of Organ Transplantation (Child Pugh score ≥ 7and MELD score ≥15).
- Donor selection:
- Living donors are usually close family members or spouses, although unrelated living donors can be accepted according to the legal registration of MOH (ministry of health)
- ABO blood type compatibility
- Age is between 18-50
- Absence of previous significant abdominal surgery and/or medical problems
Who cannot join
- Adult recipients who underwent LDLT due to other causes rather than HCV.
- Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
- Acquired immunodeficiency syndrome (AIDS)
- Malignancy outside of the liver not meeting oncologic criteria for cure
- Hepatocellular carcinoma with metastatic spread
- Anatomic abnormalities that preclude liver transplantation
Show all 10Show fewer
- Uncontrolled sepsis
- Acute liver failure with a sustained intracranial pressure >50 mmHg or a cerebral perfusion pressure <40 mmH
- Persistent non adherence with medical care and Lack of adequate social support
- Advanced age older than 65y.
About this study
The study aimed to assess HLA compatibility, HLA antibodies and cross matching in liver transplantation recipients and their relation to acute rejection, CMV infection, and recurrence of HCV.
Read the detailed description
This was a cohort study conducted in patients who had undergone LDLT between January 2015 and January 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .
HLA Typing and Mismatch:
Preoperative blood samples from all recipients and donors were collected. The serological tissue typing for HLA was performed by a SSP-PCR (sequence-specific- primer). HLA-A, HLA- B, and HLA-DR loci were examined and used to calculate mismatch scores. The locus-specific type of HLA mismatch, as well as the degree of HLA mismatch, was then assessed. For each locus individually, the mismatch number was scored as 0, 1, or 2, on the basis of the number of donor alleles not shared with the respective recipient. Each patient was assigned an overall total score depending on the total number of mismatches at the 3 loci, ranging from 0 (no mismatches at any loci) to 6 (mismatches at all loci)
Cross matching (total and autocross):
Crossmatch involves placing recipient serum (potentially containing donor-specific anti-HLA antibodies) onto donor lymphocytes (containing HLA antigens).A cytotoxic reaction (deemed 'positive') suggests the presence of preformed DSAbs (donor specific antibodies).
Autoantibodies are generally IgM rather than IgG antibodies. To establish if autoantibodies are responsible for the result an auto-crossmatch should be performed. In this assay, recipient serum is crossmatched against recipient (rather than donor) lymphocytes. Second, the original crossmatch should be repeated with the addition of the agent Dithiothreitol (DTT). DTT reduces the disulfide bonds in IgM thereby preventing IgM antibodies from generating a positive result. IgM antibodies are generally regarded as having no pathological significance in transplantation.
- Conditions
- Liver Transplantation
- Being tested
- HLA cross matching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA cross matchingDiagnostic test
HLA Typing and Mismatch
Cross matching (total and autocross):
Cross match involves placing recipient serum onto donor lymphocytes and a cytotoxic reaction (deemed 'positive') suggests the presence of preformed donor specific antibodies (DSAs),Second, the original crossmatch should be repeated with the addition of the agent Dithiothreitol (DTT). DTT reduces the disulfide bonds in IgM thereby preventing IgM antibodies from generating a positive result.
| Study group | Role | What they receive |
|---|---|---|
| Liver transplantation receipients | All patients underwent Living donor liver transplantation at Ain Shams center for organ transplantation (ASCOT) during the designed study period Receives: Diagnostic Test: HLA cross matching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between HLA cross matching and post transplantation outcome
We o investigated the post transplantation laboratory data, incidence of acute rejection, recurrence of hepatitis C virus (HCV) infection and CMV infection as outcome parameters.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start1 Jan 2015
- Primary completion1 Jan 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iman Fawzy Montasser, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094728
- Sponsor's protocol ID
- HLA and liver transplantation
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2017
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Human Leukocyte Antigen Matching in Liver Transplantation and Its Relation to Outcomes
- ClinicalTrials.gov ID
- NCT03094728
- Acronym / sponsor ID
- HLA and liver transplantation
- Conditions
- Liver Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 29 Mar 2017 (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 aimed to assess HLA compatibility, HLA antibodies and cross matching in liver transplantation recipients and their relation to acute rejection, CMV infection, and recurrence of HCV.
Detailed description
This was a cohort study conducted in patients who had undergone LDLT between January 2015 and January 2016 at in Ain Shams Center for Organ Transplantation (ASCOT) .
HLA Typing and Mismatch:
Preoperative blood samples from all recipients and donors were collected. The serological tissue typing for HLA was performed by a SSP-PCR (sequence-specific- primer). HLA-A, HLA- B, and HLA-DR loci were examined and used to calculate mismatch scores. The locus-specific type of HLA mismatch, as well as the degree of HLA mismatch, was then assessed. For each locus individually, the mismatch number was scored as 0, 1, or 2, on the basis of the number of donor alleles not shared with the respective recipient. Each patient was assigned an overall total score depending on the total number of mismatches at the 3 loci, ranging from 0 (no mismatches at any loci) to 6 (mismatches at all loci)
Cross matching (total and autocross):
Crossmatch involves placing recipient serum (potentially containing donor-specific anti-HLA antibodies) onto donor lymphocytes (containing HLA antigens).A cytotoxic reaction (deemed 'positive') suggests the presence of preformed DSAbs (donor specific antibodies).
Autoantibodies are generally IgM rather than IgG antibodies. To establish if autoantibodies are responsible for the result an auto-crossmatch should be performed. In this assay, recipient serum is crossmatched against recipient (rather than donor) lymphocytes. Second, the original crossmatch should be repeated with the addition of the agent Dithiothreitol (DTT). DTT reduces the disulfide bonds in IgM thereby preventing IgM antibodies from generating a positive result. IgM antibodies are generally regarded as having no pathological significance in transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liver transplantation receipients | – | Diagnostic Test: HLA cross matchingAll patients underwent Living donor liver transplantation at Ain Shams center for organ transplantation (ASCOT) during the designed study period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with end stage liver diseases potential candidates for living donor liver transplantation and their donors
Key inclusion criteria (7 listed)
- Recipient selection:
- Living donors are usually close family members or spouses, although unrelated living donors can be accepted according to the legal registration of MOH (ministry of health)
- ABO blood type compatibility
- Age is between 18-50
- Absence of previous significant abdominal surgery and/or medical problems
Key exclusion criteria (10 listed)
- Adult recipients who underwent LDLT due to other causes rather than HCV.
- Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery
- Acquired immunodeficiency syndrome (AIDS)
- Malignancy outside of the liver not meeting oncologic criteria for cure
- Hepatocellular carcinoma with metastatic spread
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 |
|---|---|---|
| HLA cross matchingHLA Typing and Mismatch Cross matching (total and autocross): Cross match involves placing recipient serum onto donor lymphocytes and a cytotoxic reaction (deemed 'positive') suggests the presence of preformed donor specific antibodies (DSAs),Second, the original crossmatch should be repeated with the addition of the agent Dithiothreitol (DTT). DTT reduces the disulfide bonds in IgM thereby preventing IgM antibodies from generating a positive result. | Diagnostic test | Liver transplantation receipients |
Primary outcome
Relation between HLA cross matching and post transplantation outcome
Time frame: 1 year
We o investigated the post transplantation laboratory data, incidence of acute rejection, recurrence of hepatitis C virus (HCV) infection and CMV infection as outcome parameters.
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 29 Mar 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplantation, run by Ain Shams University.
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 7 inclusion and 10 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 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Relation between HLA cross matching and post transplantation outcome (time frame: 1 year). 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 29 Mar 2017.