Use Of Fragmin In Hemodialysis

January 30, 2017 updated by: Pfizer

A Phase IIIb Open Label Study To Optimize The Single Bolus Dose Of Dalteparin Sodium For The Prevention Of Clotting Within The Extracorporeal System During Hemodialysis Procedures For Subjects With Chronic Renal Insufficiency: The Parrot Study

The study will determine if the Fragmin dose can be adjusted to suit the clinical needs of patients during dialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

152

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1R 2J6
        • CHU de Quebec (Pavillon Hotel-Dieu de Quebec)
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta Hospital
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Community Hospital
      • Edmonton, Alberta, Canada, T5G 0B8
        • Royal Alexandra Hospital
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
        • Horizon Health Network/Saint John Regional Hospital
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Eastern Regional Health Authority, Health Sciences Centre
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Eastern Regional Health Authority, St. Clare's Mercy Hospital
      • St. John's, Newfoundland and Labrador, Canada, A1E 4J8
        • Eastern Regional Health Authority, Waterford Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Queen Elizabeth II Health Sciences Center (QEII) - VG Site
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • William Osler Health System - Bramptom Civic Hospital
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre, University Hospital
      • London, Ontario, Canada, N6K 1M6
        • London Health Sciences Centre, Kidney Care Centre
      • Orangeville, Ontario, Canada, L9W 4X9
        • William Osler Health System
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre
      • Greenfield Park, Quebec, Canada, J4V 3M3
        • Centre externe de néphrologie CISSS de la Montérégie-Centre
      • Montreal, Quebec, Canada, H2X 3J4
        • Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc
      • Montreal, Quebec, Canada, H3M 3E3
        • CIUSSS du Nord-de-l'Île-de-Montréal
      • Montreal, Quebec, Canada, H4J 1C5
        • CIUSSS du Nord-de-l'Île-de-Montréal
      • Saint-Lambert, Quebec, Canada, J4R 2L1
        • Centre externe de néphrologie CISSS de la Montérégie-Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic renal failure on hemodialysis

Exclusion Criteria:

  • significant comorbidities that would prevent a patient from completing the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fragmin
Fragmin given according to the flexible dosing regimen outlined in the protocol
Drug: Fragmin
variable dosing regimen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent of Successful HD Sessions
Time Frame: 20 HD sessions (up to 4 hours)
A successful HD session is defined in terms of efficacy of the drug where the HD session had completed as planned: there was no premature termination due to Grade 3 or 4 clotting or saline flush to prevent the loss of the extracorporeal circuit due to clotting; it was not possible to return the participant's blood or assess the exact extent of clotting. HD sessions which terminated prematurely due to Grade 1 or 2 clotting, safety event, machine failure, or access site displacement were excluded from the analysis. The point estimate and 95% CI were computed based on generalized estimating equation (GEE) model for clustered binomial data.
20 HD sessions (up to 4 hours)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Percent of HD Sessions With an Acceptable Dose
Time Frame: 20 HD sessions (up to 4 hours)
A HD session with an acceptable dose is defined in terms of efficacy of the drug: an HD session for which the dose at the next HD session did not need to be changed due to Grade 3 or 4 clotting, bleeding, access compression time > 10 minutes, or other clinical event. The point estimate and 95% CI were computed based on GEE model for clustered binomial.
20 HD sessions (up to 4 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

June 13, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 18, 2013

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6301091

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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