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

Completed

• Conditions: End-stage kidney disease; Urological and Genital Diseases; Kidney disease

• Registration Number: ISRCTN35253449
• Lead Sponsor: niversity of Calgary (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-15
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 340

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified