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

NCT02225782 | Unknown

• 1 other identifier: KFOC140002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Disease

Keywords

Alteplase; Hemodialysis Catheter; Occlusion; Renal Failure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of catheter strippings

  after 3 repeates of tPA management with a waiting time of 30 minutes between each tPA repeat

Study Arms (2)

1.0 mg alteplase (tPA)

ACTIVE COMPARATOR

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

Drug: Alteplase

2.0 mg alteplase (tPA)

EXPERIMENTAL

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

Drug: Alteplase

Interventions

Alteplase DRUG

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

Also known as: tPA

1.0 mg alteplase (tPA); 2.0 mg alteplase (tPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is ≥ 18 years of age,
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Windsor: lead
• The Kidney Foundation of Canada: collaborator

Study Sites (1)

Windsor Regional Hospital

Windsor, Ontario, N9A 1A1, Canada

RECRUITING

MeSH Terms

Conditions

Kidney Diseases; Bites and Stings; Renal Insufficiency

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors

Study Officials

• Maher M El-Masri, PhD

  University of Windsor

  PRINCIPAL INVESTIGATOR

• Albert Kadri, MD

  Windsor Regional Hospital

  PRINCIPAL INVESTIGATOR

• Wasim S El Nekidy, PharmD

  Windsor Regional Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maher M El-Masri, PhD

CONTACT

51932533000; melmasri@uwindsor.ca

Albert Kadri, MD

CONTACT

5199460103; dr.kadri@careforkidneys.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Faculty Research Chair

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 26, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

CA (1)