Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates

CD62P(P-selectin) as a Marker of Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates

The aim of this study to assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .

Study Overview

• Status: Not yet recruiting
• Conditions: Platelet Storage Lesion(PSL)

Detailed Description

Platelet transfusion is a lifesaving procedure that is carried out to prevent bleeding or stop ongoing bleeding in patients with low platelet count or functional platelet disorders. There are minimum thresholds at which platelets are transfused in these patients, as not all low levels of platelet warrants a transfusion. Platelet is a scarce resource as processing, preparing, and transfusing it requires a great deal of precision and effort to maintain a certain quality. This activity highlights the use of platelet transfusion by the interprofessional team (1).

Platelets play an integral role in hemostasis by its response to vascular injury. The relevance of platelet component therapy was better understood in the 1950s and 1960s when severe and fatal hemorrhagic complications of chemotherapy in leukemia were studied

The collected blood units were randomly assigned to two groups:

1. Non-filtered platelet concentrates (NF-PC group).
2. leukocyte-depleted platelet concentrates (LD-PC group). P-selectin (CD62p) is a type of glycoprotein stored in the Weibel-Palade bodies of vascular endothelial cells and platelet α-granules. Activated CD62P is a transmembrane protein expressed on the platelet surface. During platelet activation, the expression of CD62P on the surface of the cell membrane is dramatically increased in PCs without leukocyte depletion, due to the presence of WBCs and cytokines ,and is accompanied by an increase in the expression level of plasma soluble CD62

• Study Type: Observational
• Enrollment (Anticipated): 180

Contacts and Locations

• Study Contact: Name: Merna M. Ayad, resident; Phone Number: 01284539330; Email: Mernamamdoh150@gmail.com
• Study Contact Backup: Name: Maha A. Mohamed, professor; Phone Number: 01000004572; Email: Atwa_maha@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All gender fullfilling inclusion criteria are participating in this study ,

Description

Inclusion Criteria:

• Donors who met criteria of Egyptian National Transfusion services
• Donors who had not taken any antiplatelet drugs for two weeks prior to donation
• pre-collection platelet count ≥200×109 /L.
• Blood grouping.
• Serological assays for all blood donors (HBsAgs, HCV antibodies, HIV Ag/Ab Syphilis antibodies) on Architect i 2000 SR or Centaur XPT (chemoluminescence).

Exclusion Criteria:

• Donors who not met criteria of Egyptian National Transfusion services
• Donors who had taken any antiplatelet drugs for two weeks prior to donation
• pre-collection platelet count <200×109 /L.
• Reactive serology

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Non-filtered platelet concentrates (NF-PC group).; In NF-PC group, 90 whole blood units were collected with Tripple blood bags, Six NF-PCs were pooled together and stored in a horizonal shaker at 20 ± 2C for 5 days .
leukocyte-depleted platelet concentrates (LD-PC group).; In LD-PC group, another 90 whole blood units were collected using Whole Blood Filter Saving Platelets (WB-SP) bags with an integrated leukoreduction filter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess platelet activation .	assess platelet activation during 5 days storage of platelet concentrates prepared by different techinques .	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CD62p assessment .	CD62p assessment of platelet storage lesion(PSL)in platelet concentrates .	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Freireich EJ. Origins of platelet transfusion therapy. Transfus Med Rev. 2011 Jul;25(3):252-6. doi: 10.1016/j.tmrv.2011.01.003. Epub 2011 Mar 2.
• Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005 Dec;115(12):3339-47. doi: 10.1172/JCI26674.
• Solves Alcaina P. Platelet Transfusion: And Update on Challenges and Outcomes. J Blood Med. 2020 Jan 24;11:19-26. doi: 10.2147/JBM.S234374. eCollection 2020.
• Cines DB, Levine LD. Thrombocytopenia in pregnancy. Hematology Am Soc Hematol Educ Program. 2017 Dec 8;2017(1):144-151. doi: 10.1182/asheducation-2017.1.144.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): March 1, 2025

Study Registration Dates

• First Submitted: November 21, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 3, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: platelet storage lesion

Drug and device information, study documents

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