Effect of Platelet Storage on Complement Activation | NCT03280823

Studies
Effect of Platelet Storage on Complement Activation

NCT03280823

Sponsor

Shimaa Abdeleem

Status

Unknown status

Last Update Posted

Sep 13, 2017Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Platelet Storage

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

Sep 2017

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, 2017Estimated

Primary Completion Date

Sep 2018Estimated

Completion Date

Dec 2018Estimated

First Submitted Date

Aug 29, 2017

First Submission Date that Met QC Criteria

Sep 11, 2017

First Posted Date

Sep 13, 2017Actual

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

Sep 11, 2017

Last Update Posted Date

Sep 13, 2017Actual

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

Platelet units are stored and complement factors are evaluated

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

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

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Platelets can be used after storage upto 5 days instead of using in the same day of donation without complement activation.		5 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Yes

Sex/Gender Description

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

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shimaa A Ahmed	Contact	01065952778		shimaaabdeleem11@gmail.com
Maha A Mahmoud	Contact	01000004572		atwa-maha@yahoo.com

Overall Officials

Not provided

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28671303	Background	Chen J, Losos M, Yang S, Li J, Wu H, Cataland S. Increased complement activation during platelet storage. Transfusion. 2017 Sep;57(9):2182-2188. doi: 10.1111/trf.14215. Epub 2017 Jul 3.