A Phase 2 interventional study of Sodium Bicarbonate 8.4% Solution for Injection and Alteplase Injectable Solution in Cancer and Central Venous Catheterization, sponsored by University Health Network, Toronto. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
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.
Exclusion Criteria:
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 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
3 mL injection into line with up to 2 injections administered
2 mL injection into line with up to 2 injections administered
Successful clearance rate of sodium bicarbonate
Time frame: 3 hours
Successful clearance rate of alteplase
Time frame: 3 hours
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto