Use Of Fragmin In Hemodialysis

Phase 3CompletedNCT01879618

Pfizer152 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

152

Conditions

Chronic Renal Failure

Interventions

FragminDRUG

variable dosing regimen

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic renal failure on hemodialysis Exclusion Criteria: * significant comorbidities that would prevent a patient from completing the trial

Locations (19)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Outcomes

Primary Outcomes

Mean Percent of Successful HD Sessions

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.

Time frame: 20 HD sessions (up to 4 hours)

Secondary Outcomes

Mean Percent of HD Sessions With an Acceptable Dose

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.

Time frame: 20 HD sessions (up to 4 hours)

Data from ClinicalTrials.gov

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