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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01356576
Other study ID # 10-039
Secondary ID
Status Completed
Phase N/A
First received May 13, 2011
Last updated February 6, 2014
Start date September 2010
Est. completion date September 2011

Study information

Verified date February 2014
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date September 2011
Est. primary completion date September 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
United States Island Rehabilitative Service Staten Island New York

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health Staten Island University Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Drop in platelet counts 90 minutes through hemodialysis and immediately after finishing hemodialysis No
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