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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Recruitment Status : Withdrawn (No participants were enrolled)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

Tracking Information
First Submitted Date  ICMJE November 16, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date September 16, 2020
Estimated Study Start Date  ICMJE June 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2017)
  • Successful clearance rate of sodium bicarbonate [ Time Frame: 3 hours ]
  • Successful clearance rate of alteplase [ Time Frame: 3 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Sodium Bicarbonate in Restoring Blocked Catheters
Official Title  ICMJE Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cancer
  • Central Venous Catheterization
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Alteplase then Sodium Bicarbonate
    Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
    Interventions:
    • Drug: Sodium Bicarbonate 8.4% Solution for Injection
    • Drug: Alteplase Injectable Solution
  • Experimental: Sodium Bicarbonate then Alteplase
    Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.
    Interventions:
    • Drug: Sodium Bicarbonate 8.4% Solution for Injection
    • Drug: Alteplase Injectable Solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 11, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 16, 2017)
608
Estimated Study Completion Date  ICMJE September 2, 2021
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03348826
Other Study ID Numbers  ICMJE SBI-FLOW
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Minden, M.D. Princess Margaret Cancer Centre
PRS Account University Health Network, Toronto
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP