Alteplase for Blood Flow Restoration in Hemodialysis Catheters

NCT00303420 | Terminated Phase 4 DMC

• 1 other identifier: B2003:119
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 9

Brief Summary

We are investigating a new way of administering alteplase to remove clots from hemodialysis catheters. Currently, alteplase is left to dwell inside the catheter between dialysis treatments to dissolve the clot and restore blood flow through the catheter. We have developed a new way to administer alteplase by advancing it to the tip of the catheter at regular 10 minute intervals. We hypothesize that our new "push" protocol will dissolve clots in hemodialysis catheters better and faster than the current dwell method.

Conditions

Thrombosis

Keywords

catheter; hemodialysis; dysfunction; thrombolytic; alteplase

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with pre-thrombolytic blood flows less than 200 ml/min achieving a "sustainable" post thrombolytic blood flow > or = 300 ml/min.

  4 hours

Secondary Outcomes (4)

• Highest recorded "sustainable" blood flow (ml/min) pre- and post- thrombolytic administration.

  4 hours

• Change in Kt/V from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.

  72 hours

• Change in "litres processed / time" from the treatment before thrombolytic administration compared to the treatment after thrombolytic administration.

  72 hours

• Serious adverse events including major bleeding within 24 hours of alteplase administration

  30 days post-last dose

Study Arms (2)

1

ACTIVE COMPARATOR

Alteplase used by normal dwell procedure

Drug: alteplase dwell arm

2

EXPERIMENTAL

Alteplase given by an new "push" protocol

Drug: Alteplase "push" protocol

Interventions

Alteplase "push" protocol DRUG

alteplase 2 mg / lumen. Instill and wait 10 minutes, instill 0.3 ml normal saline, wait 10 minutes, instill 0.3 ml of normal saline, wait 10 minutes and aspirate.

Also known as: CathFlo, alteplase, rTPA

2

alteplase dwell arm DRUG

alteplase 2 mg / lumen. Instill and let it dwell for 30 minutes. Assess catheter and allow to dwell for a total of 2 hours if necessary

Also known as: Cathflo, alteplase, rTPA

1

Eligibility Criteria

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

You may qualify if:

• Adults \> 18 yrs old
• Hemodialysis patients
• Vascular access with a permanent catheter
• No prior rt-PA use in the catheter over the previous 21 days
• One rt-PA instillation per catheter (i.e. we will only document the results of 1 rt-PA instillation per catheter. Numerous rt-PA instillations in the same catheter will NOT be considered new events, and not entered into the study)

You may not qualify if:

• Critically ill patients in the ICU setting.
• Contraindications / cautions with alteplase use including: known hypersensitivity to alteplase or its components (l-arginine, phosphoric acid, polysorbate 80), patients with known conditions associated with bleeding events (e.g.intracranial bleed in last 4 weeks, major hemorrhage in last 4 weeks (Hgb drop of 20 g/L)), recent surgery (\<48 hours), recent biopsy (\<48 hours), hemostatic defects including severe hepatic disease, or current intracranial / intraspinal neoplasm.
• Hemodialysis catheter has been in the patient less than 14 days.

Sponsors & Collaborators

• University of Manitoba: lead
• Hoffmann-La Roche: collaborator

Study Sites (9)

Brandon General Hospital

Brandon, Manitoba, R7A 2B3, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Seven Oaks Hospital

Winnipeg, Manitoba, R2V 3M3, Canada

Location

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

St. Joseph's Hospital

Hamilton, Ontario, L8N 1Y3, Canada

Location

Grand River Hospital

Kitchener, Ontario, N2G 1G3, Canada

Location

Thunderbay Regional Health Sciences Centre

Thunderbay, Ontario, P7B 6V4, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Maisonneuve Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

• Zacharias JM, Weatherston CP, Spewak CR, Vercaigne LM. Alteplase versus urokinase for occluded hemodialysis catheters. Ann Pharmacother. 2003 Jan;37(1):27-33. doi: 10.1345/aph.1C105.

  PMID: 12503929 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

Tissue Plasminogen Activator

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

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

• Lavern M Vercaigne, Pharm.D.

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• James M Zacharias, MD

  University of Manitoba, Internal Medicine, Section of Nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 15, 2006
• First Posted: March 16, 2006
• Study Start: September 1, 2004
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 19, 2008

Record last verified: 2008-12

Locations

CA (9)