Establishing the efficacy of masking the clinically significant blood group antigens on human RBCs by a biocompatible material
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- • 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.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 59.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •RBC samples from healthy non remunerated voluntary blood donors.
Exclusion Criteria
- •RBC samples that are reactive for Transfusion Transmitted Infections or positive for Direct Coombs Test will be excluded.
Outcomes
Primary Outcomes
• 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.
Time Frame: Baseline , 24 hours
Secondary Outcomes
No secondary outcomes reported
Investigators
Bismita BIswabandini
Kasturba Medical College