Effect of Hemodialysis Membranes on Platelet Count

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Edward Epstein, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01356576
First received: May 13, 2011
Last updated: February 6, 2014
Last verified: February 2014
  Purpose

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
Thrombocytopenia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Effect of Hemodialysis Membranes on Platelet Count

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • Drop in platelet counts [ Time Frame: 90 minutes through hemodialysis and immediately after finishing hemodialysis ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356576

Locations
United States, New York
Island Rehabilitative Service
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
Investigators
Principal Investigator: Edwerd Epstein, M.D. Staten Island University Hospital
  More Information

No publications provided

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
Study First Received: May 13, 2011
Last Updated: February 6, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014