Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates

NCT ID: NCT05144074

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-03-31

Brief Summary

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

Detailed Description

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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

Conditions

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Platelet Storage Lesion(PSL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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 .

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Merna Mamdoh Ayad Benyamen

resident

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Merna M. Ayad, resident

Role: CONTACT

Phone: 01284539330

Email: [email protected]

Maha A. Mohamed, professor

Role: CONTACT

Phone: 01000004572

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 21371858 (View on PubMed)

Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005 Dec;115(12):3339-47. doi: 10.1172/JCI26674.

Reference Type BACKGROUND
PMID: 16322778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32158298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29222249 (View on PubMed)

Other Identifiers

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platelet storage lesion

Identifier Type: -

Identifier Source: org_study_id