ThrombosisPhase 4NCT00303420
Alteplase for Blood Flow Restoration in Hemodialysis Catheters
A Phase 4 study testing Alteplase "push" protocol and alteplase dwell arm in people with Thrombosis, run by University of Manitoba at 9 sites in Canada.
Trial summary
We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombosis
- What is being tested?
- Alteplase "push" protocol and alteplase dwell arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 9 sitesCanada
- Study dates
- Sep 2004to Dec 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults > 18 yrs old
- Hemodialysis patients
- Vascular access with a permanent catheter
- No prior rt-PA use in the catheter over the previous 21 days
- One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)
Who cannot join
- Critically ill patients in the ICU setting.
- Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (<48 hours), recent biopsy (<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
- Hemodialysis catheter has been in the patient less than 14 days.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Canada9 sites
Brandon General Hospital
Brandon, Manitoba, R7A 2B3
St. Joseph's Hospital
Hamilton, Ontario, L8N 1Y3
Grand River Hospital
Kitchener, Ontario, N2G 1G3
Maisonneuve Rosemont Hospital
Montreal, Quebec, H1T 2M4
Thunderbay Regional Health Sciences Centre
Thunderbay, Ontario, P7B 6V4
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
Seven Oaks Hospital
Winnipeg, Manitoba, R2V 3M3
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial
We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Read the detailed description
Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
- Conditions
- Thrombosis
- Being tested
- Alteplase "push" protocol, alteplase dwell arm
- Keywords
- catheter, hemodialysis, dysfunction, thrombolytic, alteplase
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alteplase "push" protocolDrug
Also called CathFlo, alteplase, rTPA
alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate.
alteplase dwell armDrug
Also called Cathflo, alteplase, rTPA
alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Alteplase used by normal dwell procedure Receives: Drug: alteplase dwell arm |
| 2 | Experimental | Alteplase given by an new "push" protocol Receives: Drug: Alteplase "push" protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
Measured: 4 hours
Secondary outcomes (4)
Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.
Measured: 4 hours
Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Measured: 72 hours
Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Measured: 72 hours
Serious adverse events including major bleeding within 24 hours of alteplase administration
Measured: 30 days post-last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2006 (estimated)
- Study startSep 2004
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Unable to enrol enough people to achieve the full sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Lavern M Vercaigne, Pharm.D., Principal investigator, University of ManitobaJames M Zacharias, MD, Principal investigator, University of Manitoba, Internal Medicine, Section of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303420
- Sponsor's protocol ID
- B2003:119
- Status last verified
- Dec 2008
- First submitted
- 15 Mar 2006
- Last updated
- 19 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33. doi: 10.1345/aph.1C105.
PubMed 12503929
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alteplase for Blood Flow Restoration in Hemodialysis Catheters: A Randomized Prospective Clinical Trial
- ClinicalTrials.gov ID
- NCT00303420
- Acronym / sponsor ID
- B2003:119
- Conditions
- Thrombosis
- Keywords
- catheter, hemodialysis, dysfunction, thrombolytic, alteplase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to enrol enough people to achieve the full sample size
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Sep 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Mar 2006 (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.
We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Detailed description
Central venous catheters are commonly used for vascular access in the hemodialysis population. A common complication is low / no blood flow through the catheter due to clots. These are serious situations because patients may miss dialysis sessions and suffer significant morbidity. In an attempt to dissolve the clots and restore blood flow, thrombolytics are frequently instilled into the catheters between dialysis sessions . However, we have developed and new "push" protocol that advances fresh thrombolytic (alteplase) to the tip of the catheter in order to facilitate more effective and faster removal of the clot. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: alteplase dwell armAlteplase used by normal dwell procedure |
| 2 | Experimental | Drug: Alteplase "push" protocolAlteplase given by an new "push" protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults > 18 yrs old
- Hemodialysis patients
- Vascular access with a permanent catheter
- No prior rt-PA use in the catheter over the previous 21 days
- One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)
Key exclusion criteria (3 listed)
- Critically ill patients in the ICU setting.
- Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (<48 hours), recent biopsy (<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
- Hemodialysis catheter has been in the patient less than 14 days.
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 |
|---|---|---|
| Alteplase "push" protocolAlso: CathFlo, alteplase, rTPAalteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate. | Drug | 2 |
| alteplase dwell armAlso: Cathflo, alteplase, rTPAalteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary | Drug | 1 |
Primary outcome
Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.
Time frame: 4 hours
4 secondary outcomes
Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.
Time frame: 4 hours
Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Time frame: 72 hours
Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.
Time frame: 72 hours
Serious adverse events including major bleeding within 24 hours of alteplase administration
Time frame: 30 days post-last dose
Results and safety
The study was stopped early (reason given: Unable to enrol enough people to achieve the full sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2008.
- Background: PubMed 12503929Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33. doi: 10.1345/aph.1C105.
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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.
Lavern M Vercaigne, Pharm.D. principal investigator
University of Manitoba
James M Zacharias, MD principal investigator
University of Manitoba, Internal Medicine, Section of Nephrology
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alteplase "push" protocol and alteplase dwell arm in people with Thrombosis, run by University of Manitoba at 9 sites 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 19 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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.
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 was stopped early (reason given: Unable to enrol enough people to achieve the full sample size). Results are not available in the source record.
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?
Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00303420, which also lists 1 linked publication.
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 19 Dec 2008.