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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02225782
Other study ID # KFOC140002
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received August 22, 2014
Last updated August 25, 2014
Start date September 2014
Est. completion date December 2016

Study information

Verified date August 2014
Source University of Windsor
Contact Maher M El-Masri, PhD
Phone 51932533000
Email melmasri@uwindsor.ca
Is FDA regulated No
Health authority Canada: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Alteplase
Alteplase is a fibrinolytic drug widely used to restore hemodialysis catheter patency.

Locations

Country Name City State
Canada Windsor Regional Hospital Windsor Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Windsor The Kidney Foundation of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Restoration of hemodialysis catheter The pharmacist will prepare all 1.0mg and the 2.0mg doses in 2.0ml syringes; whereby the 1.0mg dose will be prepared in a concentration of 1.0mg/2.0ml, while the 2.0mg dose will be prepared in a concentration of 2.0mg/2.0ml. The varying syringe concentrations will ensure that both doses are identical to ensure the blinding of the two study groups. Once ready to administer the tPA according to the medical directive, the HD nurse will instill the prefilled tPA solution into the occluded HDC lumen and allow it to dwell in the lumen for 30 minutes. The HD nurse will then withdraw 3.0 ml of blood from the occluded lumen and assess for patency. If there is a backflow and the HDC is deemed patent, the HD nurse will recommence HD. If the HDC lumen is not patent after the first instill, the HD nurse may repeat the tPA administration procedure up to a maximum of a total of three times before a referral for therapeutic radiology is arranged to strip the catheter 30 minutes after administration of the tPA at the catheter site No
Secondary Number of catheter strippings Comparing the number of catheter stripping procedures between patients who have their occluded catheters managed by 1.0 mg tPA versus 2.0 mg after 3 repeates of tPA management with a waiting time of 30 minutes between each tPA repeat No
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