<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/NCT03280823</url>
  </required_header>
  <id_info>
    <org_study_id>platelets and complement</org_study_id>
    <nct_id>NCT03280823</nct_id>
  </id_info>
  <brief_title>Effect of Platelet Storage on Complement Activation</brief_title>
  <official_title>Effect of Platelet Storage on Complement Activation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shimaa Abdeleem</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>
      Platelet units are stored and complement factors are evaluated&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten units of platelets will be selected from the regular inventory of the Central Blood&#xD;
      Transfusion Services/Assiut University Hospitals . All units of platelets will be collected,&#xD;
      processed, and tested following the standard procedures.&#xD;
&#xD;
      Thesis units will be stored on a platelet rotator with the temperature controlled between 22&#xD;
      and 24c. Samples will be obtained using a sterile technique .&#xD;
&#xD;
      The investigators will take basal sample and samples on day 2,3,4 and 5. Complement&#xD;
      components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal&#xD;
      pathway).&#xD;
&#xD;
      This evaluation will be done using ELISA technique&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">September 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation.</measure>
    <time_frame>5 days</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Platelet Storage</condition>
  <eligibility>
    <study_pop>
      <textblock>
        No Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the&#xD;
        platelets.&#xD;
&#xD;
        Negative screening and confirmatory tests will be done for all platelet donors&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Negative screening and confirmatory tests will be done for all platelet donors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the&#xD;
             platelets.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Negative screening and confirmatory tests will be done for all platelet donors</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Shimaa A Ahmed</last_name>
    <phone>01065952778</phone>
    <email>shimaaabdeleem11@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maha A Mahmoud</last_name>
    <phone>01000004572</phone>
    <email>atwa-maha@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Chen J, Losos M, Yang S, Li J, Wu H, Cataland S. Increased complement activation during platelet storage. Transfusion. 2017 Sep;57(9):2182-2188. doi: 10.1111/trf.14215. Epub 2017 Jul 3.</citation>
    <PMID>28671303</PMID>
  </reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Shimaa Abdeleem</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <keyword>complement system</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/NCT03280823
org study id: platelets and complement
nct id: NCT03280823
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Platelet units are stored and complement factors are evaluated
Ten units of platelets will be selected from the regular inventory of the Central Blood
      Transfusion Services/Assiut University Hospitals . All units of platelets will be collected,
      processed, and tested following the standard procedures.

      Thesis units will be stored on a platelet rotator with the temperature controlled between 22
      and 24c. Samples will be obtained using a sterile technique .

      The investigators will take basal sample and samples on day 2,3,4 and 5. Complement
      components will be assayed : C4 (classical pathway), C3 (common pathway) and C5 (terminal
      pathway).

      This evaluation will be done using ELISA technique
observational model: Other
time perspective: Prospective
measure: Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation.
time frame: 5 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Negative screening and confirmatory tests will be done for all platelet donors
minimum age: 18 Years
maximum age: 45 Years
last name: Shimaa A Ahmed
phone: 01065952778
email: shimaaabdeleem11@gmail.com
last name: Maha A Mahmoud
phone: 01000004572
email: atwa-maha@yahoo.com
citation: Chen J, Losos M, Yang S, Li J, Wu H, Cataland S. Increased complement activation during platelet storage. Transfusion. 2017 Sep;57(9):2182-2188. doi: 10.1111/trf.14215. Epub 2017 Jul 3.
PMID: 28671303
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Shimaa Abdeleem
investigator title: Doctor