CancerPhase 2NCT03348826
Study of Sodium Bicarbonate in Restoring Blocked Catheters
A Phase 2 study testing Sodium Bicarbonate 8.4% Solution for Injection and Alteplase Injectable Solution in people with Cancer and Central Venous Catheterization, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers. Central line devices uses thin tubes that are placed into a vein in the body to give medicines, fluids, nutrients, blood products, etc. Sometimes, the lines become blocked. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Central Venous Catheterization
- What is being tested?
- Sodium Bicarbonate 8.4% Solution for Injection and Alteplase Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to 2 Sep 2021
- Phase
- Phase 2
- 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
- Hematology patients with indwelling CVC/PICC line.
- Patients continuing to receive chemotherapy treatment for consolidation, intensification and maintenance regimens in hematological malignancies such as in acute leukemia, lymphoma, myelodysplastic syndrome, supportive care measures using blood products, ongoing anti-infective treatments, and nutrition.
- Patients whose CVC/PICC line becomes obstructed during routine care are being identified and presented to attending physician and pharmacist.
- Mechanical obstruction having been ruled out by visual inspection and manipulation of the patient's posture or extremities or both.
Who cannot join
- Patients with hemodialysis line occlusions
- Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)
This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers.
Central line devices uses thin tubes that are placed into a vein in the body to give medicines, fluids, nutrients, blood products, etc.
Read more
Sometimes, the lines become blocked. The standard procedure to get the line working again is to use alteplase, a protein that dissolves blood clots. While blood clotting is one cause of a blocked line, other reasons included the formation of calcium deposits. Sodium bicarbonate is routinely used in the treatment of patients receiving chemotherapy. Sodium bicarbonate is a liquid drug which is capable of dissolving protein and calcium deposits.
This study will compare whether sodium bicarbonate works just as well as alteplase to recover the function of a blocked line.
- Conditions
- Cancer, Central Venous Catheterization
- Being tested
- Sodium Bicarbonate 8.4% Solution for Injection, Alteplase Injectable Solution
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Bicarbonate 8.4% Solution for InjectionDrug
3 mL injection into line with up to 2 injections administered
Alteplase Injectable SolutionDrug
2 mL injection into line with up to 2 injections administered
| Study group | Role | What they receive |
|---|---|---|
| Alteplase then Sodium Bicarbonate | Experimental | Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered. Receives: Drug: Sodium Bicarbonate 8.4% Solution for Injection; Drug: Alteplase Injectable Solution |
| Sodium Bicarbonate then Alteplase | Experimental | Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered. Receives: Drug: Sodium Bicarbonate 8.4% Solution for Injection; Drug: Alteplase Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful clearance rate of sodium bicarbonate
Measured: 3 hours
Successful clearance rate of alteplase
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start1 Jun 2020 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion2 Sep 2021 (estimated)
Why it stopped: No participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Minden, M.D., Principal investigator, Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348826
- Sponsor's protocol ID
- SBI-FLOW
- Status last verified
- Sep 2020
- First submitted
- 16 Nov 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)
- ClinicalTrials.gov ID
- NCT03348826
- Acronym / sponsor ID
- SBI-FLOW
- Conditions
- Cancer, Central Venous Catheterization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 2 Sep 2021 (estimated)
- First posted
- 21 Nov 2017 (actual)
- 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.
This is a study looking at the use of sodium bicarbonate to restore the flow of blocked central line devices in patients with blood cancers.
Central line devices uses thin tubes that are placed into a vein in the body to give medicines, fluids, nutrients, blood products, etc.
Sometimes, the lines become blocked. The standard procedure to get the line working again is to use alteplase, a protein that dissolves blood clots. While blood clotting is one cause of a blocked line, other reasons included the formation of calcium deposits. Sodium bicarbonate is routinely used in the treatment of patients receiving chemotherapy. Sodium bicarbonate is a liquid drug which is capable of dissolving protein and calcium deposits.
This study will compare whether sodium bicarbonate works just as well as alteplase to recover the function of a blocked line.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alteplase then Sodium Bicarbonate | Experimental | Drug: Sodium Bicarbonate 8.4% Solution for Injection, Drug: Alteplase Injectable SolutionAlteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered. |
| Sodium Bicarbonate then Alteplase | Experimental | Drug: Sodium Bicarbonate 8.4% Solution for Injection, Drug: Alteplase Injectable SolutionSodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hematology patients with indwelling CVC/PICC line.
- Patients continuing to receive chemotherapy treatment for consolidation, intensification and maintenance regimens in hematological malignancies such as in acute leukemia, lymphoma, myelodysplastic syndrome, supportive care measures using blood products, ongoing anti-infective treatments, and nutrition.
- Patients whose CVC/PICC line becomes obstructed during routine care are being identified and presented to attending physician and pharmacist.
- Mechanical obstruction having been ruled out by visual inspection and manipulation of the patient's posture or extremities or both.
Key exclusion criteria (2 listed)
- Patients with hemodialysis line occlusions
- Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions
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 |
|---|---|---|
| Sodium Bicarbonate 8.4% Solution for Injection3 mL injection into line with up to 2 injections administered | Drug | Alteplase then Sodium Bicarbonate, Sodium Bicarbonate then Alteplase |
| Alteplase Injectable Solution2 mL injection into line with up to 2 injections administered | Drug | Alteplase then Sodium Bicarbonate, Sodium Bicarbonate then Alteplase |
Primary outcome
Successful clearance rate of sodium bicarbonate
Time frame: 3 hours
Successful clearance rate of alteplase
Time frame: 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- 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.
Mark Minden, M.D. principal investigator
Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium Bicarbonate 8.4% Solution for Injection and Alteplase Injectable Solution in people with Cancer and Central Venous Catheterization, run by University Health Network, Toronto 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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 16 Sep 2020. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 withdrawn before enrolling participants, so there are no results.
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?
Successful clearance rate of sodium bicarbonate (time frame: 3 hours). 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 16 Sep 2020.