Effect of Hemodialysis Membranes on Platelet Count

Thrombocytopenia Clinical Trial

Official title:

Effect of Hemodialysis Membranes on Platelet Count

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356576
• Other study ID #: 10-039
• 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

• Thrombocytopenia
• Thrombocytosis

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