Assessment of Platelet Storage Lesion(PSL)in Platelet Con... | NCT05144074

Studies
Assessment of Platelet Storage Lesion(PSL)in Platelet Concentrates

NCT05144074

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Dec 3, 2021Actual

Enrollment

180Estimated

Phase

Not provided

Conditions

Platelet Storage Lesion(PSL)

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Estimated

Primary Completion Date

Dec 1, 2024Estimated

Completion Date

Mar 2025Estimated

First Submitted Date

Nov 21, 2021

First Submission Date that Met QC Criteria

Dec 2, 2021

First Posted Date

Dec 3, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 2, 2021

Last Update Posted Date

Dec 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

Non-filtered platelet concentrates (NF-PC group).
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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

All gender fullfilling inclusion criteria are participating in this study ,

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Merna M. Ayad, resident	Contact	01284539330		Mernamamdoh150@gmail.com
Maha A. Mohamed, professor	Contact	01000004572		Atwa_maha@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21371858	Background	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.
16322778	Background	Kaushansky K. The molecular mechanisms that control thrombopoiesis. J Clin Invest. 2005 Dec;115(12):3339-47. doi: 10.1172/JCI26674.