Study of Sodium Bicarbonate in Restoring Blocked Catheters
NCT ID: NCT03348826
Last Updated: 2020-09-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2020-06-01
2021-09-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alteplase then Sodium Bicarbonate
Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
Sodium Bicarbonate 8.4% Solution for Injection
3 mL injection into line with up to 2 injections administered
Alteplase Injectable Solution
2 mL injection into line with up to 2 injections administered
Sodium Bicarbonate then Alteplase
Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.
Sodium Bicarbonate 8.4% Solution for Injection
3 mL injection into line with up to 2 injections administered
Alteplase Injectable Solution
2 mL injection into line with up to 2 injections administered
Interventions
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Sodium Bicarbonate 8.4% Solution for Injection
3 mL injection into line with up to 2 injections administered
Alteplase Injectable Solution
2 mL injection into line with up to 2 injections administered
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Mark Minden, M.D.
Role: PRINCIPAL_INVESTIGATOR
Princess Margaret Cancer Centre
Locations
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Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Other Identifiers
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SBI-FLOW
Identifier Type: -
Identifier Source: org_study_id
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