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Effect of Hemodialysis Membranes on Platelet Count

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ClinicalTrials.gov Identifier: NCT01356576
Recruitment Status : Completed
First Posted : May 19, 2011
Last Update Posted : February 7, 2014
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Edward Epstein, North Shore Long Island Jewish Health System

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.

Condition or disease
Thrombocytopenia

Study Type : Observational
Actual Enrollment : 99 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effect of Hemodialysis Membranes on Platelet Count
Study Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
U.S. FDA Resources




Primary Outcome Measures :
  1. Drop in platelet counts [ Time Frame: 90 minutes through hemodialysis and immediately after finishing hemodialysis ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were being selected from the community where undergoing dialysis.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356576


Locations
United States, New York
Island Rehabilitative Service
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
Investigators
Principal Investigator: Edwerd Epstein, M.D. Staten Island University Hospital

Responsible Party: Edward Epstein, M.D., North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01356576     History of Changes
Other Study ID Numbers: 10-039
First Posted: May 19, 2011    Key Record Dates
Last Update Posted: February 7, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases