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Evaluation of ABO Isoagglutinins Level in Blood Group O Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04412993
Recruitment Status : Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Information provided by (Responsible Party):
RH Ahmed, Assiut University

Brief Summary:
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.

Condition or disease Intervention/treatment
Isoagglutinins Level 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of ABO Isoagglutinins Level in Blood Group O Donors
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: withdraw blood samples
    withdraw blood sample from gorup O donors

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
group O donors

Inclusion Criteria:

  • Healthy adults blood group O donors

Exclusion Criteria:

  • Other blood groups donors.
  • Donors with history of chronic or autoimmune diseases
Additional Information:
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Responsible Party: RH Ahmed, Assiut University Identifier: NCT04412993    
Other Study ID Numbers: ABO isoagglutinin
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by RH Ahmed, Assiut University:
urgent blood transfusion , group O