<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412993</url>
  </required_header>
  <id_info>
    <org_study_id>ABO isoagglutinin</org_study_id>
    <nct_id>NCT04412993</nct_id>
  </id_info>
  <brief_title>Evaluation of ABO Isoagglutinins Level in Blood Group O Donors</brief_title>
  <official_title>Evaluation of ABO Isoagglutinins Level in Blood Group O Donors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our study is aiming for evaluation f the titre of anti-A and anti-B in plasma of blood grop O&#xD;
      donors, study the effect of pooling of blood product on the level of A and B isoagglutinins&#xD;
      in blood group O donors and screening for the safest group o donors(who have the lowest&#xD;
      anti-A antd anti-B titre) for transfusion in urgent need of blood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the use of O blood group transfusion to patients of all groups has continued since the second&#xD;
      world war, nevertheless the transfusion of group O plasma/ platelet concentrate to group A, B&#xD;
      and AB recipient sometimes causes severe red cell destruction , Acute haemolysis has been&#xD;
      reported following transfusion of non-iso group single donor platelet (PLT) concentrates and&#xD;
      may be more common than is appreciated.&#xD;
&#xD;
      This red blood cells destruction happens based on the fact that the sera from group O people&#xD;
      contain two separable antibodies, anti-A and anti-B .&#xD;
&#xD;
      When it comes to PLT transfusion therapy we are dealing with issues arising from the fact&#xD;
      that PLTs contain both significant amounts of ABO antigen on their surface, as well as anti&#xD;
      ABO isogglutinins in the donor's plasma which caused reduction the volume of incompatible&#xD;
      plasma administrated.&#xD;
&#xD;
      From another point of view the risk of high titer units is considered low with group O, post&#xD;
      storage, pooled PLT concentrate. However its necessary to establish a (golden standard)&#xD;
      method for the determination of antibody titer in order to be able to differentiate&#xD;
      accurately the high titer donors.&#xD;
&#xD;
      So, for improving the safety of group O plts we need to define a safe level of antibody titer&#xD;
      or reduce the volume of incompatible plasma administrated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2021</start_date>
  <completion_date type="Anticipated">October 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease the risk of red cell destruction resulting from transfusion of RBCs/ platelet concentrate group O transfusion in urgent cases.</measure>
    <time_frame>2 years</time_frame>
    <description>Using blood group typ &quot;O&quot; For other blood group types without causing any reaction resulting from blood transfusion .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>screening for the best group O donors to use for other groups urgent cases as a reserve for transfusion.</measure>
    <time_frame>2 years</time_frame>
    <description>Using blood group typ &quot;O&quot; For other blood group types without causing any reaction resulting from blood transfusion .</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Isoagglutinins Level</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>withdraw blood samples</intervention_name>
    <description>withdraw blood sample from gorup O donors</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        group O donors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy adults blood group O donors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Other blood groups donors.&#xD;
&#xD;
          -  Donors with history of chronic or autoimmune diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://medcraveonline.com/HTIJ/HTIJ-01-00017.pdf</url>
    <description>Related Info</description>
  </link>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 6, 2021</last_update_submitted>
  <last_update_submitted_qc>June 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>RH Ahmed</investigator_full_name>
    <investigator_title>RH Ahmed</investigator_title>
  </responsible_party>
  <keyword>urgent blood transfusion , group O</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412993
org study id: ABO isoagglutinin
nct id: NCT04412993
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Cohort
time perspective: Prospective
measure: Decrease the risk of red cell destruction resulting from transfusion of RBCs/ platelet concentrate group O transfusion in urgent cases.
time frame: 2 years
description: Using blood group typ "O" For other blood group types without causing any reaction resulting from blood transfusion .
measure: screening for the best group O donors to use for other groups urgent cases as a reserve for transfusion.
time frame: 2 years
description: Using blood group typ "O" For other blood group types without causing any reaction resulting from blood transfusion .
intervention type: Other
intervention name: withdraw blood samples
description: withdraw blood sample from gorup O donors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
url: http://medcraveonline.com/HTIJ/HTIJ-01-00017.pdf
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: RH Ahmed
investigator title: RH Ahmed