Kidney Failure, ChronicNCT02770560
Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Hemodialysis Catheters
An observational study of Kidney Failure, Chronic and Vascular Access Devices, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Failure, Chronic, Vascular Access Devices
- What is being tested?
- Urokinase locking solution
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteBelgium
- Study dates
- May 2010to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Incident and prevalent patients on hemodialysis, more than 18y old, receiving dialysis via a tunneled cuffed catheter between 1st May 2010 and 31st October 2014.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Cuffed Catheters : a Single-center Retrospective Study
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
- Conditions
- Kidney Failure, Chronic, Vascular Access Devices
- Being tested
- Urokinase locking solution
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urokinase locking solutionDevice
Also called Actosolv
On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)
| Study group | Role | What they receive |
|---|---|---|
| Chronic hemodialysis patients with a tunneled cuffed catheter | In case of thrombotic dysfunction of the dialysis catheter : administration of Urokinase (100 000 units in total) as locking solution in the dead space of the catheter lumen, interdialytic (between two dialysis sessions) or intradialytic (during the dialysis in case of complete obstruction of the dialysis catheter) Receives: Device: Urokinase locking solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 54 months
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)
Measured: up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startMay 2010
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Bonkain, M.D., Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770560
- Sponsor's protocol ID
- 1
- Status last verified
- Dec 2015
- First submitted
- 24 Dec 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Urokinase Containing Locking Solutions for Thrombotic Dysfunction of Tunneled Cuffed Catheters : a Single-center Retrospective Study
- ClinicalTrials.gov ID
- NCT02770560
- Acronym / sponsor ID
- 1
- Conditions
- Kidney Failure, Chronic, Vascular Access Devices
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic hemodialysis patients with a tunneled cuffed catheter | – | Device: Urokinase locking solutionIn case of thrombotic dysfunction of the dialysis catheter : administration of Urokinase (100 000 units in total) as locking solution in the dead space of the catheter lumen, interdialytic (between two dialysis sessions) or intradialytic (during the dialysis in case of complete obstruction of the dialysis catheter) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Incident and prevalent patients on hemodialysis, more than 18y old, receiving dialysis via a tunneled cuffed catheter between 1st May 2010 and 31st October 2014.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urokinase locking solutionAlso: ActosolvOn basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions) | Device | Chronic hemodialysis patients with a tunneled cuffed catheter |
Primary outcome
Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution
Time frame: up to 54 months
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)
Change of pump pressures (expressed in mmHg) after Urokinase-containing locking solution
Time frame: up to 54 months
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence Bonkain, M.D. principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Failure, Chronic and Vascular Access Devices, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in catheter blood flow (expressed in ml/min) after Urokinase-containing locking solution (time frame: up to 54 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2016.