Role of Human Leukocyte Antigen Matching in Liver Transplantation and Its Relation to Outcomes

NCT03094728 | Completed DMC

• 1 other identifier: HLA and liver transplantation
• Study Type: observational
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (1)

Liver transplantation receipients

All patients underwent Living donor liver transplantation at Ain Shams center for organ transplantation (ASCOT) during the designed study period

Diagnostic Test: HLA cross matching

Interventions

HLA cross matching DIAGNOSTIC_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.

Liver transplantation receipients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with end stage liver diseases potential candidates for living donor liver transplantation and their donors

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: March 18, 2017
• First Posted: March 29, 2017
• Study Start: January 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 29, 2017

Record last verified: 2017-03