Study of Sodium Bicarbonate in Restoring Blocked Catheters

University Health Network, Toronto

Status and phase: Withdrawn; Phase 2

Conditions: Central Venous Catheterization; Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03348826

SBI-FLOW

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Alteplase then Sodium Bicarbonate

Experimental group

Description:

Alteplase will first be administered to restore flow. If flow is not restored, then sodium bicarbonate will be administered.

Treatment:

Drug: Alteplase Injectable Solution

Drug: Sodium Bicarbonate 8.4% Solution for Injection

Sodium Bicarbonate then Alteplase

Experimental group

Description:

Sodium bicarbonate will first be administered to restore flow. If flow is not restored, then alteplase will be administered.

Treatment:

Drug: Alteplase Injectable Solution

Drug: Sodium Bicarbonate 8.4% Solution for Injection