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临床试验/NCT03094728
NCT03094728已完成不适用

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

Ain Shams University0 个研究点目标入组 24 人开始时间: 2015年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
主要终点
Relation between HLA cross matching and post transplantation outcome

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Relation between HLA cross matching and post transplantation outcome

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iman Fawzy Montasser

Clinical professor

Ain Shams University

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