Study of Sodium Bicarbonate in Restoring Blocked Catheters

NCT03348826 | Withdrawn Phase 2 DMC

• 1 other identifier: SBI-FLOW
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Central Venous Catheterization

Outcome Measures

Primary Outcomes (2)

• Successful clearance rate of sodium bicarbonate

  3 hours

• Successful clearance rate of alteplase

  3 hours

Study Arms (2)

Alteplase then Sodium Bicarbonate

EXPERIMENTAL

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; 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.

Drug: Sodium Bicarbonate 8.4% Solution for Injection; Drug: Alteplase Injectable Solution

Interventions

Sodium Bicarbonate 8.4% Solution for Injection DRUG

3 mL injection into line with up to 2 injections administered

Alteplase then Sodium Bicarbonate; Sodium Bicarbonate then Alteplase

Alteplase Injectable Solution DRUG

2 mL injection into line with up to 2 injections administered

Alteplase then Sodium Bicarbonate; Sodium Bicarbonate then Alteplase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with hemodialysis line occlusions
• Anyone with documentation of prior history of alteplase allergy or hypersensitivity reactions

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Sodium Bicarbonate; Solutions; Injections

Intervention Hierarchy (Ancestors)

Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mark Minden, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: November 21, 2017
• Study Start: June 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 2, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)