跳至主要内容
临床试验/CTRI/2023/07/055250
CTRI/2023/07/055250尚未招募不适用

Establishing the application of Monocyte monolayer assay (MMA) in predicting the clinical significance of the red cell antibody.

TERUMO PENPOL1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
identifying a best matched unit that will cause no or less hemolysis compared to

研究概览

简要总结

Patients requiring best matched blood unit transfusion due to auto or allo antibodies based on the routine immunohematological work up performed will be included in the study after obtaining informed consent. Routine immunohematological work up includes Direct and indirect antiglobulin testing (DAT & IAT), Monospecific DAT, thermal amplitude of the antibody, as indicated). As per the departmental protocol, a crossmatch of 4-6 units of donors will be crossmatched with patient’s sample. The same donor samples will be utilized to assess the MMA index.  The basic principle of the test is Monocytes, the immune cells that destroy red blood cells during an adverse transfusion reaction, are isolated and placed in a single layer on a plate in the laboratory. The donor red blood cells are mixed with the patient’s antibodies and added to the monocytes. The number of monocytes with one or more red blood cells adhered/engulfed at the end of the assay is counted and this is used to calculate a “monocyte indexâ€.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •Patient with auto or allo antibodies to red cell antigen and requiring best matched blood unit transfusion.

排除标准

  • •Patients with passively acquired antibodies Patients having alloantibodies with known specificity where phenotype matched blood units will be given to the patient.

结局指标

主要结局

identifying a best matched unit that will cause no or less hemolysis compared to

时间窗: 1year

transfusion of red cells based on routine serological testing

时间窗: 1year

Performing MMA assessing the index will help us in utilizing this test in

时间窗: 1year

次要结局

  • We will be able to predict the outcome of the transfusion of antigen positive unit to(the patient with the corresponding antibodies)

研究者

发起方
TERUMO PENPOL
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

Loading locations...

相似试验