Effect of Hemodialysis Membranes on Platelet Count | NCT01356576

Studies
Effect of Hemodialysis Membranes on Platelet Count

NCT01356576

Sponsor

Northwell Health

Status

Completed

Last Update Posted

Feb 7, 2014Estimated

Enrollment

99Actual

Phase

Not provided

Conditions

Thrombocytopenia

Interventions

Not provided

Countries

United States

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

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

May 13, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 19, 2011Estimated

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

Feb 6, 2014

Last Update Posted Date

Feb 7, 2014Estimated

Name	Class
Staten Island University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to determine if there is a drop in platelet count after hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in platelets and sometimes in white blood cells. The investigators are going to study one of the membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

99Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Drop in platelet counts		90 minutes through hemodialysis and immediately after finishing hemodialysis

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients on Hemodialysis for >=6 months

Exclusion Criteria:

Hematological Cancers
- Myelodysplastic syndromes
- Baseline thrombocytopenia
- Acute infections (patients on antibiotics)
- Patients with Immune thrombocytopenic purpura (ITP)/Thrombotic thrombocytopenic purpura (TTP)
- HIV
- Liver disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients were being selected from the community where undergoing dialysis.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edwerd Epstein, M.D.	Staten Island University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Island Rehabilitative Service		Staten Island	New York	10305	United States

Condition Browse Module

MeSH Terms

ID	Term
D013921	Thrombocytopenia

Ancestor Terms

ID	Term
D001791	Blood Platelet Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D000095542	Cytopenia

Browse Leaves

Not provided

Browse Branches

Not provided