Study of Sodium Bicarbonate in Restoring Blocked Catheters

Overview

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.

Full Title of Study: “Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2020

Interventions

  • 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

Arms, Groups and Cohorts

  • Experimental: Alteplase then Sodium Bicarbonate
    • Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be 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.

Clinical Trial Outcome Measures

Primary Measures

  • Successful clearance rate of sodium bicarbonate
    • Time Frame: 3 hours
  • Successful clearance rate of alteplase
    • Time Frame: 3 hours

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mark Minden, M.D., Principal Investigator, Princess Margaret Cancer Centre

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.