Evaluation of ABO Isoagglutinins Level in Blood Group O Donors

Our study is aiming for evaluation f the titre of anti-A and anti-B in plasma of blood grop O donors, study the effect of pooling of blood product on the level of A and B isoagglutinins in blood group O donors and screening for the safest group o donors(who have the lowest anti-A antd anti-B titre) for transfusion in urgent need of blood.

Study Overview

• Status: Not yet recruiting
• Conditions: Isoagglutinins Level
• Intervention / Treatment: Other: withdraw blood samples

Detailed Description

the use of O blood group transfusion to patients of all groups has continued since the second world war, nevertheless the transfusion of group O plasma/ platelet concentrate to group A, B and AB recipient sometimes causes severe red cell destruction , Acute haemolysis has been reported following transfusion of non-iso group single donor platelet (PLT) concentrates and may be more common than is appreciated.

This red blood cells destruction happens based on the fact that the sera from group O people contain two separable antibodies, anti-A and anti-B .

When it comes to PLT transfusion therapy we are dealing with issues arising from the fact that PLTs contain both significant amounts of ABO antigen on their surface, as well as anti ABO isogglutinins in the donor's plasma which caused reduction the volume of incompatible plasma administrated.

From another point of view the risk of high titer units is considered low with group O, post storage, pooled PLT concentrate. However its necessary to establish a (golden standard) method for the determination of antibody titer in order to be able to differentiate accurately the high titer donors.

So, for improving the safety of group O plts we need to define a safe level of antibody titer or reduce the volume of incompatible plasma administrated.

• Study Type: Observational
• Enrollment (Anticipated): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

group O donors

Description

Inclusion Criteria:

• Healthy adults blood group O donors

Exclusion Criteria:

• Other blood groups donors.
• Donors with history of chronic or autoimmune diseases

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease the risk of red cell destruction resulting from transfusion of RBCs/ platelet concentrate group O transfusion in urgent cases.	Using blood group typ "O" For other blood group types without causing any reaction resulting from blood transfusion .	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
screening for the best group O donors to use for other groups urgent cases as a reserve for transfusion.	Using blood group typ "O" For other blood group types without causing any reaction resulting from blood transfusion .	2 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: May 29, 2020
• First Submitted That Met QC Criteria: May 29, 2020
• First Posted (Actual): June 2, 2020

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 6, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: urgent blood transfusion , group O
• Other Study ID Numbers: ABO isoagglutinin

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No