NCT01356576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

February 7, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

May 13, 2011

Last Update Submit

February 6, 2014

Conditions

Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

  • Drop in platelet counts

    90 minutes through hemodialysis and immediately after finishing hemodialysis

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were being selected from the community where undergoing dialysis.

You may qualify if:

  • Patients on Hemodialysis for \>=6 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Island Rehabilitative Service

Staten Island, New York, 10305, United States

Location

MeSH Terms

Conditions

Thrombocytopenia

Condition Hierarchy (Ancestors)

Blood Platelet DisordersHematologic DiseasesHemic and Lymphatic DiseasesCytopenia

Study Officials

  • Edwerd Epstein, M.D.

    Staten Island University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

May 13, 2011

First Posted

May 19, 2011

Study Start

September 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

February 7, 2014

Record last verified: 2014-02

Locations

US(1)