Chronic Renal InsufficiencyNCT02474810
Intensive Versus Standard Hemodialysis CVC Dysfunction Protocol
A study testing Alteplase in people with Chronic Renal Insufficiency, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Renal Insufficiency
- What is being tested?
- Alteplase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Sep 2015
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Capital Health District Authority, Department of Medicine, Division of Nephrology
Halifax, Nova Scotia, b3h 2y9
About this study
Official title: Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase
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.
Read the detailed 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.
- Conditions
- Chronic Renal Insufficiency
- Being tested
- Alteplase
- Keywords
- central venous catheters, hemodialysis, thrombosis, tissue plasminogen activator
- Medical subject headings
- Renal Insufficiency, Chronic, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called Cathflo, rt-PA
Alteplase for CVC dysfunction.
| Study group | Role | What they receive |
|---|---|---|
| Intensive | Experimental | In the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal Receives: Drug: Alteplase |
| Standard | Experimental | In the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow. Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alteplase use
Incident rate of rt-PA uses includes the numerator which will consist of the number of HD sessions during which a patient was administered rt-PA for catheter malfunction and the denominator will be the time period at risk in catheter days.
Measured: 9 months
Secondary outcomes (2)
Rate of bacteremia
Rate of bacteremia will include the numberator which will consit of the number of definite or probable catheter related bacteremia events and the decominator will be the time period at risk in catheter days.
Measured: 9 months
Cost of alteplase
Cost of rt-PA will be calculated per TLD for the study period.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jo-Anne S Wilson, PharmD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474810
- Sponsor's protocol ID
- Dialysis Catheter Protcols
- Status last verified
- Aug 2024
- First submitted
- 16 Jun 2015
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of an Intensive Versus a Standard Hemodialysis Central Venous Catheter Dysfunction Protocol Using Alteplase
- ClinicalTrials.gov ID
- NCT02474810
- Acronym / sponsor ID
- Dialysis Catheter Protcols
- Conditions
- Chronic Renal Insufficiency
- Keywords
- central venous catheters, hemodialysis, thrombosis, tissue plasminogen activator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jun 2015 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive | Experimental | Drug: AlteplaseIn the Intensive Protocol, alteplase intervention is administered to all catheters based on blood flow and/or line reversal |
| Standard | Experimental | Drug: AlteplaseIn the Standard Protocol, alteplase intervention is administered to all catheters based only on blood flow. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All adults undergoing HD with a tunneled CVC (both newly inserted CVCs as well as pre-existing CVCs) will be included.
Key exclusion criteria (7 listed)
- 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;
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 |
|---|---|---|
| AlteplaseAlso: Cathflo, rt-PAAlteplase for CVC dysfunction. | Drug | Intensive, Standard |
Primary outcome
Alteplase use
Time frame: 9 months
Incident rate of rt-PA uses includes the numerator which will consist of the number of HD sessions during which a patient was administered rt-PA for catheter malfunction and the denominator will be the time period at risk in catheter days.
2 secondary outcomes
Rate of bacteremia
Time frame: 9 months
Cost of alteplase
Time frame: 9 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 21 Aug 2024.
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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.
Jo-Anne S Wilson, PharmD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alteplase in people with Chronic Renal Insufficiency, run by Nova Scotia Health Authority at 1 site in Canada.
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 7 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 21 Aug 2024. 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 Canada. 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?
Alteplase use (time frame: 9 months). 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 21 Aug 2024.