Hemodialysis, Tunneled Catheter, QatarPhase 4NCT02868697
Management of Tunneled Catheter Thrombosis in Hemodialysis Patients: Prospective Study From Qatar
A Phase 4 study testing TauroLock U 25000 and (TauroLock Hep500) in people with Hemodialysis, Tunneled Catheter, Qatar, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Goal of the study: A- To find out the best protocol for catheter lock solution to decrease the prevalence of catheter thrombosis 1. - The time to first episode of catheter thrombosis lead to catheter change. 2. - Number of acute episode of thrombosis that interrupt dialysis 3. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Hemodialysis, Tunneled Catheter, Qatar
- What is being tested?
- TauroLock U 25000 and (TauroLock Hep500)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteQatar
- Study dates
- Nov 2013to Dec 2015
- Phase
- Phase 4
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1- Adult patients aged>14 years 2- Undergoing HD through tunneled HD 3- Recently inserted or old tunneled catheter 4- Blood flow rate at the beginning of the study≥ 300ml/min
Who cannot join
- 1- Malfunctioning catheter defined by blood flow rate < 300ml/min 2- Known patient to have allergy to drug medication 3- Major Hemorrhage in previous 4 week
Trial locations and contacts
1 site in 1 country.
About this study
Goal of the study:
A- To find out the best protocol for catheter lock solution to decrease the prevalence of catheter thrombosis
Read more
- - The time to first episode of catheter thrombosis lead to catheter change.
- - Number of acute episode of thrombosis that interrupt dialysis
- - Median Survival life of the catheter in both groups after adjusting it to the outcome.
B- Specific Objective: To evaluate the cost effectiveness by measure
1- Amount of r-TPA used in each group to treatment acute catheter thrombosis 2- Number of catheter exchange in both group 3- Hospitalization days related to catheter malfunctioning or CRI in each group 4- Type and days of antibiotics 5- Cost of the treatment in each group
c- Secondary Objective:
To correlate the result of two catheters lock solution protocols with the published data using r-TPA instead of heparin once week as compared with heparin 3 times per week as a locking solution.
Read the detailed description
This prospective single blind randomized controlled study. All patients who undergoing tunneled catheter regular hemodialysis in the three hemodialysis units and meet the inclusion criteria will be included in the study.
Signed informed consent will be taken from all patients or their first authorized relative.
All patients will be randomized on 1:1 basis using computer-generated program.Patients will be randomly assigned to lock the catheter post HD either with 1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis[tetrahydro-1,1,1',1'-tetraoxide], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH, www.tauropharm.de) at the end of of all Hemodialysis sessions and during all interdialytic periods or after the first two session only per week and during first two interdialytic periods then taurolidine citrate, 4% citrate /25000 IU unit urokinase (TauroLock U25000) at the end of third session before week end, (over the week end). The assigned nurse will flush the catheter after each session with 20 mL of saline then instill TauroLock according to the filling volume of the catheter. Before starting the next dialysis the lock solution has to be aspirated and discarded. Acute catheter thrombosis which interrupt the dialysis will be treated with r-TPA according to unit protocol, if this happen for three consecutive HD we will consider it as malfunction and we will refer it for catheter exchange . Any catheter will be referred to the vascular surgeon for exchange; we will not continue calculating its days as there might be a gap between referral's time and catheter exchange due admission problems. If the catheter is replaced, patient will continue on the same arm of the study.
Control Group:
We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of of all Hemodialysis sessions and during all interdialytic periods.
Intervention Group:
We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of the first two session only per week and during first two interdialytic periods then TauroLock U 25000at the end of third session before week end, (over the week end).
For episode of the acute catheter malfunctioning:-
The study coordinator will know the name of the patients who received interdialytic r-TPA from medication room then will collect the data from the patient's files. The study coordinator will follow the vascular census on daily bases to know all the patients who have catheter problems and will follow their status from dialysis and inpatient files.
For catheter related infection:-
If there is any episode of CRI, this will be documented in our infectious control file and the study coordinator will collect the data from in-patient file, dialysis file and medicom.
planned enrollment: 300 subjects
- Conditions
- Hemodialysis, Tunneled Catheter, Qatar
- Being tested
- TauroLock U 25000, (TauroLock Hep500)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TauroLock U 25000Drug
taurolidine citrate, 4% citrate /25000 IU unit urokinase (TauroLock U25000
(TauroLock Hep500)Drug
1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis[tetrahydro-1,1,1',1'-tetraoxide], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of of all Hemodialysis sessions and during all interdialytic periods Receives: Drug: (TauroLock Hep500) |
| B | Experimental | We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of the first two session only per week and during first two interdialytic periods then TauroLock U 25000at the end of third session before week end, (over the week end). Receives: Drug: TauroLock U 25000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of catheter thrombosis episodes
The time to first episode of catheter thrombosis lead to catheter change. Number of acute episode of thrombosis that interrupt dialysis Median Survival life of the catheter in both groups after adjusting it to the outcome.
Measured: 6 months per patient
Secondary outcomes (3)
Amount of r-TPA used in each group for treatment of acute catheter thrombosis
as above
Measured: 6 months
Number of catheter exchange in each group
Measured: 6 months
Hospitalization days related to catheter malfunctioning or CRI in each group
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2016 (estimated)
- Study startNov 2013
- Primary completionAug 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis, Tunneled Catheter, QatarStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02868697
- Sponsor's protocol ID
- 12180-12
- Status last verified
- Jun 2016
- First submitted
- 28 Jun 2016
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Tunneled Catheter Thrombosis in Hemodialysis Patients: Prospective Study From Qatar
- ClinicalTrials.gov ID
- NCT02868697
- Acronym / sponsor ID
- 12180-12
- Conditions
- Hemodialysis, Tunneled Catheter, Qatar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 16 Aug 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.
Goal of the study:
A- To find out the best protocol for catheter lock solution to decrease the prevalence of catheter thrombosis
- - The time to first episode of catheter thrombosis lead to catheter change.
- - Number of acute episode of thrombosis that interrupt dialysis
- - Median Survival life of the catheter in both groups after adjusting it to the outcome.
B- Specific Objective: To evaluate the cost effectiveness by measure
1- Amount of r-TPA used in each group to treatment acute catheter thrombosis 2- Number of catheter exchange in both group 3- Hospitalization days related to catheter malfunctioning or CRI in each group 4- Type and days of antibiotics 5- Cost of the treatment in each group
c- Secondary Objective:
To correlate the result of two catheters lock solution protocols with the published data using r-TPA instead of heparin once week as compared with heparin 3 times per week as a locking solution.
Detailed description
This prospective single blind randomized controlled study. All patients who undergoing tunneled catheter regular hemodialysis in the three hemodialysis units and meet the inclusion criteria will be included in the study.
Signed informed consent will be taken from all patients or their first authorized relative.
All patients will be randomized on 1:1 basis using computer-generated program.Patients will be randomly assigned to lock the catheter post HD either with 1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis[tetrahydro-1,1,1',1'-tetraoxide], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH, www.tauropharm.de) at the end of of all Hemodialysis sessions and during all interdialytic periods or after the first two session only per week and during first two interdialytic periods then taurolidine citrate, 4% citrate /25000 IU unit urokinase (TauroLock U25000) at the end of third session before week end, (over the week end). The assigned nurse will flush the catheter after each session with 20 mL of saline then instill TauroLock according to the filling volume of the catheter. Before starting the next dialysis the lock solution has to be aspirated and discarded. Acute catheter thrombosis which interrupt the dialysis will be treated with r-TPA according to unit protocol, if this happen for three consecutive HD we will consider it as malfunction and we will refer it for catheter exchange . Any catheter will be referred to the vascular surgeon for exchange; we will not continue calculating its days as there might be a gap between referral's time and catheter exchange due admission problems. If the catheter is replaced, patient will continue on the same arm of the study.
Control Group:
We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of of all Hemodialysis sessions and during all interdialytic periods.
Intervention Group:
We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of the first two session only per week and during first two interdialytic periods then TauroLock U 25000at the end of third session before week end, (over the week end).
For episode of the acute catheter malfunctioning:-
The study coordinator will know the name of the patients who received interdialytic r-TPA from medication room then will collect the data from the patient's files. The study coordinator will follow the vascular census on daily bases to know all the patients who have catheter problems and will follow their status from dialysis and inpatient files.
For catheter related infection:-
If there is any episode of CRI, this will be documented in our infectious control file and the study coordinator will collect the data from in-patient file, dialysis file and medicom.
planned enrollment: 300 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: (TauroLock Hep500)We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of of all Hemodialysis sessions and during all interdialytic periods |
| B | Experimental | Drug: TauroLock U 25000We will lock the dialysis catheter post HD with TauroLock Hep500 at the end of the first two session only per week and during first two interdialytic periods then TauroLock U 25000at the end of third session before week end, (over the week end). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1- Adult patients aged>14 years 2- Undergoing HD through tunneled HD 3- Recently inserted or old tunneled catheter 4- Blood flow rate at the beginning of the study≥ 300ml/min
Key exclusion criteria (1 listed)
- 1- Malfunctioning catheter defined by blood flow rate < 300ml/min 2- Known patient to have allergy to drug medication 3- Major Hemorrhage in previous 4 week
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 |
|---|---|---|
| TauroLock U 25000taurolidine citrate, 4% citrate /25000 IU unit urokinase (TauroLock U25000 | Drug | B |
| (TauroLock Hep500)1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis[tetrahydro-1,1,1',1'-tetraoxide], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH | Drug | A |
Primary outcome
Number of catheter thrombosis episodes
Time frame: 6 months per patient
The time to first episode of catheter thrombosis lead to catheter change. Number of acute episode of thrombosis that interrupt dialysis Median Survival life of the catheter in both groups after adjusting it to the outcome.
3 secondary outcomes
Amount of r-TPA used in each group for treatment of acute catheter thrombosis
Time frame: 6 months
Number of catheter exchange in each group
Time frame: 6 months
Hospitalization days related to catheter malfunctioning or CRI in each group
Time frame: 6 months
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 16 Aug 2016.
- Individual participant dataSharing planned: Yes
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TauroLock U 25000 and (TauroLock Hep500) in people with Hemodialysis, Tunneled Catheter, Qatar, run by Hamad Medical Corporation at 1 site in Qatar.
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 1 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 16 Aug 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 Qatar. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of catheter thrombosis episodes (time frame: 6 months per patient). 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 16 Aug 2016.