Trial to Compare 1.0 Versus 2.0 mg Alteplase (tPA) Dosing in Restoring Hemodialysis Catheter Function

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Hemodialysis is a procedure that kidney physicians perform when the kidneys fail and can no longer clean the blood and remove extra fluid and toxins from the body. Hemodialysis therefore requires access to reach the blood through either a surgically created permanent fistula or graft or through the insertion of a temporary catheter in one of the large body veins. While the use of fistulas or grafts is preferred because they are permanent, there may be conditions that prevent patients from having them and a hemodialysis catheter may be used instead. The problem with the use of catheters however is that they can become blocked due to the formation of blood clots. Kidney physicians try to resolve occlusion of hemodialysis catheters by injecting a medication called Alteplase which breaks the clot at the catheter site. There is no consensus in the medical community as to how much of the medication should be injected at the occluded catheter site. While some kidney physicians and studies recommend the use of 1.0 mg of the medication at each occlusion site, others recommend that 2.0 mg of the medication should be used. Thus, the purpose of this randomized clinical trial is to compare the effectiveness of 1.0mg versus 2.0mg dose of alteplase in resolving blood clots in hemodialysis catheters.

The investigators will recruit patients for the study from a regional hemodialysis unit that is located in southwestern Ontario. Patients who agree to participate in this research and experiences occlusion of their hemodialysis catheters will be divided into two groups; making sure that this division is completely by chance. The first group will receive 1.0mg alteplase, while the second will receive 2.0mg Alteplase. The investigators will collect information on both groups and will run statistical analysis of these information to compare the results of clot resolution between the groups.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Windsor
• Collaborator: The Kidney Foundation of Canada
• Treatments: Tissue Plasminogen Activator

Criteria

Inclusion Criteria:

• A patient will be deemed eligible for inclusion in the study if he/she:

1. Is ≥ 18 years of age,

2. Is receiving HD for chronic renal failure using permanent HDC that is inserted in any of the following sites: internal jugular, subclavian, or femoral veins

3. Has no medical contradiction for tPA management of partially or fully occluded HDC.

In addition, only the first occlusion event that requires tPA administration for a single catheter will be included. However, each new catheter insertion for the same patient during the study will be treated as a new event. That is, a single patient may be randomized more than one time if he/she experiences the insertion of more than one catheter during the course of the study

Exclusion Criteria:

• Pregnant women

• Patients who received ≤ 7 dialysis treatment sessions or have been on dialysis for less than 15 days

• Patients who had contraindications, allergies, or history of intolerances to tPA will be excluded