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Study of Sodium Bicarbonate in Restoring Blocked Catheters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03348826
Recruitment Status : Withdrawn (No participants were enrolled)
First Posted : November 21, 2017
Last Update Posted : September 16, 2020
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Cancer Central Venous Catheterization Drug: Sodium Bicarbonate 8.4% Solution for Injection Drug: Alteplase Injectable Solution Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)
Estimated Study Start Date : June 1, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 2, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Alteplase then Sodium Bicarbonate
Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
 Drug: Sodium Bicarbonate 8.4% Solution for Injection
3 mL injection into line with up to 2 injections administered

Drug: Alteplase Injectable Solution
2 mL injection into line with up to 2 injections administered
Experimental: Sodium Bicarbonate then Alteplase
Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.
 Drug: Sodium Bicarbonate 8.4% Solution for Injection
3 mL injection into line with up to 2 injections administered

Drug: Alteplase Injectable Solution
2 mL injection into line with up to 2 injections administered


Outcome Measures
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Primary Outcome Measures :
  1. Successful clearance rate of sodium bicarbonate [ Time Frame: 3 hours ]
  2. Successful clearance rate of alteplase [ Time Frame: 3 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with hemodialysis line occlusions
  • Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03348826


Locations
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Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Mark Minden, M.D. Princess Margaret Cancer Centre
More Information
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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03348826    
Other Study ID Numbers: SBI-FLOW
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tissue Plasminogen Activator
Pharmaceutical Solutions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action