Use Of Fragmin In Hemodialysis

Phase 3

Completed

• Conditions: Chronic Renal Failure
• Interventions: Drug: Fragmin

• Registration Number: NCT01879618
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-13
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-18
• Study Start: 2013-10
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Results First Submitted: 2016-11-02
• Results First Submitted QC: 2016-11-02
• Results First Posted: 2016-12-29
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

• chronic renal failure on hemodialysis

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fragmin	Fragmin	Fragmin given according to the flexible dosing regimen outlined in the protocol

Primary Outcome Measures

Name	Time	Method
Mean Percent of Successful HD Sessions	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.

Secondary Outcome Measures

Name	Time	Method
Mean Percent of HD Sessions With an Acceptable Dose	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.

Trial Locations

Locations (17)

Horizon Health Network/Saint John Regional Hospital; 🇨🇦 Saint John, New Brunswick, Canada

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Queen Elizabeth II Health Sciences Center (QEII) - VG Site; 🇨🇦 Halifax, Nova Scotia, Canada

Centre Hospitalier de l'Universite de Montreal (CHUM) - Hopital Saint-Luc; 🇨🇦 Montreal, Quebec, Canada

CHU de Quebec (Pavillon Hotel-Dieu de Quebec); 🇨🇦 Quebec, Canada

Eastern Regional Health Authority, Waterford Hospital; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Eastern Regional Health Authority, St. Clare's Mercy Hospital; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

William Osler Health System - Bramptom Civic Hospital; 🇨🇦 Brampton, Ontario, Canada

Royal Alexandra Hospital; 🇨🇦 Edmonton, Alberta, Canada

London Health Sciences Centre, University Hospital; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre, Kidney Care Centre; 🇨🇦 London, Ontario, Canada

Centre externe de néphrologie CISSS de la Montérégie-Centre; 🇨🇦 Saint-Lambert, Quebec, Canada

William Osler Health System; 🇨🇦 Orangeville, Ontario, Canada

CIUSSS du Nord-de-l'Ile-de-Montreal; 🇨🇦 Montreal, Quebec, Canada

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

Eastern Regional Health Authority, Health Sciences Centre; 🇨🇦 St. John's, Newfoundland and Labrador, Canada

Centre intégré de santé et de services sociaux de la Montérégie-Centre; 🇨🇦 Greenfield Park, Quebec, Canada