跳至主要内容
临床试验/CTRI/2025/06/089051
CTRI/2025/06/089051尚未招募不适用

Establishing the efficacy of masking the clinically significant blood group antigens on human RBCs by a biocompatible material

TERUMO PENPOL1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
• The study design will aid in determining the optimal concentration of bio compatible material which can effectively mask red cell antigen. • The red cells post coating should retain their structure and functionality.

研究概览

简要总结

Red blood cells membrane has multiple clinically significant antigens. These antigens when present in donor sample may have unwanted immune reactions with recipient serum antibodies if present and cause agglutination/hemolysis. To overcome this unwarranted clinical scenario, we can immune camouflage these antigens by biocompatible chemical, thereby reducing transfusion reactions. PEG is our choice of this material. In aqueous solution each PEG molecule is surrounded by a hydration sphere. Hence a PEG coated RBC membrane will attract water molecules and this hydration shell shall block antibody from reaching its specific antigen, hence masking it. The study will be conducted with a collaboration between the Department of Immunohaemotology and Blood Transfusion and Department of Pharmaceutical Sciences and after approval from the Institutional Ethics Committee. Samples from healthy blood donor will be considered for the study. We will then proceed to confirm blood grouping by both forward and reverse typing methods. During routine immunohematological work up, DAT positive and Mixed Field reactivity samples will not be included

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 59.00 Year(s)(—)
性别
All

入选标准

  • RBC samples from healthy non remunerated voluntary blood donors.

排除标准

  • RBC samples that are reactive for Transfusion Transmitted Infections or positive for Direct Coombs Test will be excluded.

结局指标

主要结局

• The study design will aid in determining the optimal concentration of bio compatible material which can effectively mask red cell antigen. • The red cells post coating should retain their structure and functionality.

时间窗: Baseline , 24 hours

次要结局

未报告次要终点

研究者

发起方
TERUMO PENPOL
申办方类型
Pharmaceutical industry-Indian
责任方
Principal Investigator
主要研究者

Bismita BIswabandini

Kasturba Medical College

研究点 (1)

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