Clinical trial NCT05144074: Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates
Official title: CD62P(P-selectin) as a Marker of Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Platelet Storage Lesion(PSL)
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All gender fullfilling inclusion criteria are participating in this study ,

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

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

Eligibility criteria: 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

Primary outcomes:
measure: assess platelet activation .
timeFrame: baseline
Secondary outcomes:
measure: CD62p assessment .
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005 Dec;115(12):3339-47. doi: 10.1172/JCI26674.
citation: 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.
citation: 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.