Overview

This trial is active, not recruiting.

Condition chronic renal insufficiency
Treatment alteplase
Sponsor Nova Scotia Health Authority
Start date January 2013
End date July 2015
Trial size 35 participants
Trial identifier NCT02474810, Dialysis Catheter Protcols

Summary

Central venous catheters (CVCs) are used for vascular access by approximately 56% of our 380 hemodialysis (HD) patients at the Capital Health Renal Program. The major complication of these catheters includes thrombosis and infection. Catheter locking solutions such as recombinant tissue plasminogen activator (rt-PA), Alteplase (Cathflo®) are used to treat and prevent clotting of the catheter during HD treatments and during the interdialytic period. Evidence to guide the use of rt-PA is limited. This quality assurance project will compare the effectiveness and cost of an intensive versus a standard catheter dysfunction protocol for rt-PA in HD patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal
alteplase Cathflo
Alteplase for CVC dysfunction.
(Experimental)
In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow.
alteplase Cathflo
Alteplase for CVC dysfunction.

Primary Outcomes

Measure
Alteplase use
time frame: 9 months

Secondary Outcomes

Measure
Rate of bacteremia
time frame: 9 months
Cost of alteplase
time frame: 9 months

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included. Exclusion Criteria: - Patients were excluded from using the CVC dysfunction protocols if they had a known allergy or intolerance to rt-PA. - A physician order to proceed with the CVC dysfunction protocols was required if they met one of the following criteria: - CVC line insertion or exchange within 72 hours; - any surgery, organ biopsy, obstetrical delivery within 72 hours; - active bleeding; bleeding disorders; hemoglobin decrease greater than 20 g/L over 2 weeks; - active pericarditis; arterial puncture within 48 hours; - bacteremia with positive blood cultures.

Additional Information

Official title Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase
Principal investigator Jo-Anne S Wilson, PharmD
Description The proposed study will be a retrospective cohort study of consecutive HD patients conducted at a HD unit using two catheter dysfunction protocols during January 2013 to Septebmer 2013. In the Intensive Protocol, rt-PA intervention is administered to all catheters based on blood flow and/or line reversal. In the Standard Protocol, rt-PA intervention is administered to all catheters based only on blood flow.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Nova Scotia Health Authority.