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Thrombolytic Agent

2.0 mg alteplase (tPA) for Kidney Disease

N/A
Waitlist Available
Led By Maher M El-Masri, PhD
Research Sponsored by University of Windsor
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 3 repeates of tpa management with a waiting time of 30 minutes between each tpa repeat
Awards & highlights

Study 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 3 repeates of tpa management with a waiting time of 30 minutes between each tpa repeat
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 3 repeates of tpa management with a waiting time of 30 minutes between each tpa repeat for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hemodialysis
Secondary outcome measures
Number of catheter strippings

Side effects data

From 2017 Phase 4 trial • 81 Patients • NCT02159521
10%
Deep vein thrombosis
8%
Nausea
6%
Procedural haemorrhage
4%
Pain in extremity
4%
Back pain
3%
Bradycardia
3%
Asthma
3%
Haematoma
3%
Anaemia
3%
Haematuria
3%
Pruritus
3%
Contusion
3%
Anxiety
1%
Upper gastrointestinal haemorrhage
1%
Dyspnoea
1%
Pulmonary embolism
1%
Osteomyelitis
1%
Urinary tract infection
1%
Epistaxis
1%
Joint effusion
1%
Abdominal pain
1%
Dizziness
1%
Uterine haemorrhage
1%
Post procedural haemorrhage
1%
Oedema
1%
Groin pain
1%
Skin ulcer
1%
Migraine
1%
Blood fibrinogen decreased
1%
Cardiac failure congestive
1%
Venous occlusion
1%
Heparin-induced thrombocytopenia
1%
Atrial fibrillation
1%
Septic shock
1%
Oxygen saturation decreased
1%
Rash
1%
Haemoptysis
1%
Constipation
1%
Sinusitis
1%
Haemorrhage
1%
Dysuria
1%
Hypoaesthesia
1%
Insomnia
1%
Drug hypersensitivity
1%
Squamous cell carcinoma
1%
Hypertension
1%
Pneumonia aspiration
1%
Lactic acidosis
1%
Ecchymosis
1%
Injection site haemorrhage
1%
Pelvic venous thrombosis
1%
Ventricular extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
EkoSonic® Endovascular System

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2.0 mg alteplase (tPA)Experimental Treatment1 Intervention
2.0 mg tPA to be injected at the catheter site for a maximum of 3 repeats if the catheter site occlusion is not resolved with 30 minute wait between each repeat
Group II: 1.0 mg alteplase (tPA)Active Control1 Intervention
1.0 mg tPA to be injected at the catheter site for a maximum of 3 repeats if the catheter site occlusion is not resolved with 30 minute wait between each repeat
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alteplase
FDA approved

Find a Location

Who is running the clinical trial?

University of WindsorLead Sponsor
10 Previous Clinical Trials
6,904 Total Patients Enrolled
The Kidney Foundation of CanadaOTHER
14 Previous Clinical Trials
2,815 Total Patients Enrolled
Maher M El-Masri, PhDPrincipal InvestigatorUniversity of Windsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~14 spots leftby May 2025