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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02770560
Other study ID # 1
Secondary ID
Status Completed
Phase N/A
First received December 24, 2015
Last updated May 11, 2016
Start date May 2010
Est. completion date November 2014

Study information

Verified date December 2015
Source Universitair Ziekenhuis Brussel
Contact n/a
Is FDA regulated No
Health authority Ethics Committee Universitair Ziekenhuis Brussel : Belgium
Study type Observational

Clinical Trial Summary

Thrombotic dysfunction is a common complication of tunneled cuffed catheters (TCC) leading to inadequate dialysis dose, need to catheter replacement with as consequence progressive exclusion of vascular sites. Thrombolytic agent can be used as therapeutic locking solution to dissolve the clotting formed in of around the catheter lumen. There are few studies on the optimal approach of TCC-related thrombosis with thrombolytic containing locking solution (dose, number of administrations, timing of administration - intra or interdialytic use). The primary objective of this retrospective study was to compare the efficacy of inter versus intradialytic Urokinase containing locking solution on restoration of the TCC blood flow. The investigators also assess the question of multiple administrations of Urokinase are more efficient than one single administration


Recruitment information / eligibility

Status Completed
Enrollment 148
Est. completion date November 2014
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Hemodialysis patients over 18 years old, receiving hemodialysis between 1st May 2010 and 31st October 2014 via a tunneled cuffed catheter at the Hemodialysis Unit of Universitair Ziekenhuis Brussel Hospital.

Exclusion Criteria:

- Patients younger than 18 years old

- Patients with a temporary dialysis catheter

- Patients who never received a tunneled hemodialysis catheter in this period

- Patients who didn't have a medical file at the Universitair Ziekenhuis Brussel Hospital

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Intervention

Device:
Urokinase locking solution
On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)

Locations

Country Name City State
Belgium Universitair Ziekenhuis Brussel Jette Brussels

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution Comparison of catheter blood flow measurement before and after Urokinase locking solution administration according to the type of Urokinase prescription (inter- versus intra-dialytic use, one- single versus multiple administrations) up to 54 months No
Primary Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution Comparison of pump pressures measurement before and after Urokinase locking solution administration according to the type of prescription of Urokinase containing locking solution (inter versus intra-dialytic, one single use versus multiple administrations) up to 54 months No
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