Efficacy of alteplase 1 versus 2 mg dose in restoring haemodialysis catheter function (Alte-dose 2): A randomized double-blind controlled study.

Aim: Data about the optimal alteplase dose required to treat haemodialysis catheter occlusion (HDC) are scarce. The purpose of the clinical trial was to examine the effectiveness of alteplase 2 mg as compared with 1 mg in restoring HDC function.

Methods: A double-blind, randomized, controlled clinical trial was conducted in a single-centre in southwestern Ontario, Canada. Rate of clot resolution, catheter replacements, catheter stripping, and mean catheter survival time were assessed using Kaplan-Meier, Cox-proportional hazard and clustered logic regression analyses.

Results: On a sample of 48 haemodialysis patients who provided 252 catheter occlusion events, the rate of clot resolution at the catheter site in the 2 mg group was 85.7% as opposed to 84.9% in the 1 mg group. There were only six catheter removals and 10 catheter stripping events. Cox regression analysis revealed no difference between the two groups in the hazard of occlusion on the primary 48 observations after the initial alteplase management (P = 0.267; hazard ratio = 0.72; 95% confidence interval 0.40-1.3). Correlated logistic regression on all 252 observations indicated no difference in the rate of post alteplase clot resolution (P = 0.336; odds ratio = 2.4, 95% confidence interval 0.399-14.6) between the two groups.

Conclusion: Alteplase 1 mg is as effective as 2 mg in restoring HDC malfunction and may result in cost reduction in haemodialysis units.