Study of Sodium Bicarbonate in Restoring Blocked Catheters

Phase 2

Withdrawn

• Conditions: Cancer; Central Venous Catheterization
• Interventions: Drug: Sodium Bicarbonate 8.4% Solution for Injection; Drug: Alteplase Injectable Solution

• Registration Number: NCT03348826
• Lead Sponsor: University Health Network, Toronto

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 available

Study Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-16
• Study First Posted: 2017-11-21
• Study Start: 2020-06-01
• Status Verified: 2020-09
• Primary Completion: 2020-09-01
• Last Update Submitted: 2020-09-11
• Last Update Posted: 2020-09-16
• Study Completion: 2021-09-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alteplase then Sodium Bicarbonate	Sodium Bicarbonate 8.4% Solution for Injection	Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
Alteplase then Sodium Bicarbonate	Alteplase Injectable Solution	Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.
Sodium Bicarbonate then Alteplase	Sodium Bicarbonate 8.4% Solution for Injection	Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.
Sodium Bicarbonate then Alteplase	Alteplase Injectable Solution	Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.

Primary Outcome Measures

Name	Time	Method
Successful clearance rate of sodium bicarbonate	3 hours
Successful clearance rate of alteplase	3 hours

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada