Study of Sodium Bicarbonate in Restoring Blocked Catheters

Study Overview
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Brief Summary
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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.

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

Conditions
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Cancer, Central Venous Catheterization

Intervention / Treatment
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* Drug: Sodium Bicarbonate 8.4% Solution for Injection
* Drug: Alteplase Injectable Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alteplase then Sodium Bicarbonate<br>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<br>* 3 mL injection into line with up to 2 injections administered<br>Drug: Alteplase Injectable Solution<br>* 2 mL injection into line with up to 2 injections administered<br>|
| Experimental: Sodium Bicarbonate then Alteplase<br>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<br>* 3 mL injection into line with up to 2 injections administered<br>Drug: Alteplase Injectable Solution<br>* 2 mL injection into line with up to 2 injections administered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful clearance rate of sodium bicarbonate |  | 3 hours | 
| Successful clearance rate of alteplase |  | 3 hours |