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Prevention of Catheter Lumen Occlusion with recombinant tissue plasminogen activator (rT-PA) versus Heparin (Pre-CLOT): A Double Blind Randomized Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN35253449
Enrollment
340
Registered
2005-06-15
Start date
2005-04-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage kidney disease Urological and Genital Diseases Kidney disease

Interventions

rT-PA 1 mg/lumen as a dialysis catheter locking solution used once per week, compared to heparin 5000 units/ml (luminal volume).

Sponsors

University of Calgary (Canada)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. End-stage renal disease (ESRD) patients 18 years of age and older with newly inserted permanent, tunnelled, dual-lumen catheters 2. Naive to study but not naive to catheters 3. Expected to use catheter for at least six months 4. Frequency of dialysis three times per week 5. Baseline international normalised ratio (INR) less than or equal to 1.3 6. Baseline platelet count greater than or equal to 60

Exclusion criteria

Exclusion criteria: 1. Use of systemic anticoagulation 2. Insertion of catheter by guide-wire exchange 3. Insertion of catheter into femoral vein 4. Current use of antibiotics for catheter-related bacteraemia 5. Major haemorrhage within prior 4 weeks 6. History of intra-cranial or intra-spinal neoplasm 7. Allergy to rT-PA 8. Active pericarditis 9. Weight less than 30 kg 10. Pregnant or lactating 11. Major surgery in past 48 hours 12. Presence of fever

Design outcomes

Primary

MeasureTime frame
Catheter malfunction.

Secondary

MeasureTime frame
Catheter related bacteremia.

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 30, 2026