Study of Sodium Bicarbonate in Restoring Blocked Catheters

Sponsor

University Health Network, Toronto (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03348826

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cancer Central Venous Catheterization	Drug: Sodium Bicarbonate 8.4% Solution for Injection Drug: Alteplase Injectable Solution	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Sodium Bicarbonate Injections for Restoration of Flow in a Central Venous Catheter (CVC/Hickman Catheter) or Peripherally Inserted Central Venous Catheter (PICC)

Anticipated Study Start Date :

Jun 1, 2020

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Sep 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alteplase then Sodium Bicarbonate 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 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
Experimental: Sodium Bicarbonate then Alteplase 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 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

Arm

Intervention/Treatment

Experimental: Alteplase then Sodium Bicarbonate

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

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

Experimental: Sodium Bicarbonate then Alteplase

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

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

Outcome Measures

Primary Outcome Measures

Successful clearance rate of sodium bicarbonate [3 hours]
Successful clearance rate of alteplase [3 hours]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator: Mark Minden, M.D., Princess Margaret Cancer Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT03348826

Other Study ID Numbers:

SBI-FLOW

First Posted:

Nov 21, 2017

Last Update Posted:

Sep 16, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tissue Plasminogen Activator

Pharmaceutical Solutions

Study Results

No Results Posted as of Sep 16, 2020