Prevention of catheter lumen occlusion with rT-PA versus heparin (Pre-CLOT): study protocol of a randomized trial
Brenda R Hemmelgarn1, Louise Moist, Rachel M Pilkey
1Division of Nephrology, Department of Medicine, University of Calgary, Calgary, Alberta, Canada. brenda.hemmelgarn@calgaryhealthregion.ca
Insights
The PreCLOT study compares tissue plasminogen activator (rt-PA) with heparin for hemodialysis catheter locking. Weekly rt-PA may reduce catheter malfunction and thrombosis, offering a potentially more effective solution for end-stage renal disease patients.
Area of Science:
- Nephrology
- Vascular Access
- Thrombosis Prevention
Background:
- Central venous catheters are crucial for hemodialysis in end-stage renal disease.
- Catheter malfunction, often due to thrombosis, affects a majority within a year.
- Optimal catheter locking solutions to prevent thrombosis remain undetermined.
Purpose of the Study:
- To compare the efficacy of weekly recombinant tissue plasminogen activator (rt-PA) versus heparin as a catheter locking solution.
- To determine if rt-PA reduces catheter malfunction and thrombosis compared to heparin.
- To assess the cost-effectiveness of rt-PA versus heparin for catheter maintenance.
Main Methods:
- The Prevention of Catheter Lumen Occlusion with rt-PA versus Heparin (PreCLOT) study is a randomized trial.
- 340 patients with chronic hemodialysis catheters across 14 Canadian sites were recruited.
- Primary outcome: catheter malfunction; Secondary outcome: catheter-related bacteremia; Cost-effectiveness analysis included.
Main Results:
- Data not yet available as the study is ongoing.
- The study aims to provide definitive data on catheter malfunction rates.
- Analysis will include blood flow parameters and bacteremia rates.
Conclusions:
- Study results will clarify if weekly rt-PA is superior to heparin for preventing hemodialysis catheter malfunction.
- Findings will inform clinical practice regarding catheter locking solutions.
- Cost-effectiveness of rt-PA will be evaluated alongside clinical outcomes.
Background:
Many patients with end-stage renal disease use a central venous catheter for hemodialysis access. A large majority of these catheters malfunction within one year of insertion, with up to two-thirds due to thrombosis. The optimal solution for locking the catheter between hemodialysis sessions, to decrease the risk of thrombosis and catheter malfunction, is unknown. The Prevention of Catheter Lumen Occlusion with rt-PA versus Heparin (PreCLOT) study will determine if use of weekly rt-PA, compared to regular heparin, as a catheter locking solution, will decrease the risk of catheter malfunction.
Methods/Design:
The study population will consist of patients requiring chronic hemodialysis thrice weekly who are dialyzed with a newly inserted permanent dual-lumen central venous catheter. Patients randomized to the treatment arm will receive rt-PA 1 mg per lumen once per week, with heparin 5,000 units per ml as a catheter locking solution for the remaining two sessions. Patients randomized to the control arm will receive heparin 5,000 units per ml as a catheter locking solution after each dialysis session. The study treatment period will be six months, with 340 patients to be recruited from 14 sites across Canada. The primary outcome will be catheter malfunction, based on mean blood flow parameters while on hemodialysis, with a secondary outcome of catheter-related bacteremia. A cost-effectiveness analysis will be undertaken to assess the cost of maintaining a catheter using rt-PA as a locking solution, compared to the use of heparin.
Discussion:
Results from this study will determine if use of weekly rt-PA, compared to heparin, will decrease catheter malfunction, as well as assess the cost-effectiveness of these locking solutions.
