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Effect of Platelet Storage on Complement Activation

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03280823
Recruitment Status : Unknown
Verified September 2017 by Shimaa Abdeleem, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Shimaa Abdeleem, Assiut University

Brief Summary:
Platelet units are stored and complement factors are evaluated

Condition or disease
Platelet Storage

Detailed Description:

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

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Effect of Platelet Storage on Complement Activation
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2018



Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Negative screening and confirmatory tests will be done for all platelet donors
Sampling Method:   Non-Probability Sample
Study Population

No Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.

Negative screening and confirmatory tests will be done for all platelet donors

Criteria

Inclusion Criteria:

  • Negative screening and confirmatory tests will be done for all platelet donors

Exclusion Criteria:

  • Use of aspirin or non steroidal anti-inflammatory drugs or medication affecting the platelets.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03280823


Contacts
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Contact: Shimaa A Ahmed 01065952778 shimaaabdeleem11@gmail.com
Contact: Maha A Mahmoud 01000004572 atwa-maha@yahoo.com

Sponsors and Collaborators
Shimaa Abdeleem
Publications:
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Responsible Party: Shimaa Abdeleem, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03280823    
Other Study ID Numbers: platelets and complement
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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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 Shimaa Abdeleem, Assiut University:
complement system