Table 1.
Study inclusion and exclusion criteria
| Inclusion criteria: |
| • End stage renal disease patients with newly inserted permanent, tunnelled, dual-lumen catheter |
| • Naïve to study but not naïve to catheters (both virgin and non-virgin catheters will be included) |
| • Expected to use catheter, and to dialyze at study centre, for at least six months |
| • Frequency of hemodialysis 3 times per week |
| • If indication for catheter was replacement for catheter related infection patients will be eligible after the infection has been treated and the patient has been off antibiotics for 3 hemodialysis sessions |
| • Patient or legal representative able to provide written consent |
| • Eighteen years of age or older |
| • Baseline INR ≤ 1.3 |
| • Baseline platelet count ≥ 60 × 109/L |
| Exclusion criteria: |
| • Use of systemic anticoagulation (if indication for anticoagulation is catheter patency patients may be eligible if the systemic anticoagulation is discontinued and baseline INR is = 1.3) |
| • Insertion of a new permanent catheter by a guide-wire exchange procedure |
| • Insertion of a new permanent catheter into the femoral vein |
| • Current use of antibiotics for catheter-related bacteremia (see inclusion criteria above) |
| • Major hemorrhage in the prior 4 weeks, defined as bleeding resulting in a drop in hemoglobin of greater than 20 g/L or bleeding requiring transfusion of packed red blood cells with other clinical evidence or suspicion of bleeding |
| • History of intra-cranial bleed in the prior 4 weeks |
| • Intra-cranial or intra-spinal neoplasm (current) |
| • Allergy or intolerance to rt-PA or heparin or its constituents |
| • Active pericarditis – defined by the presence of a pericardial rub |
| • Weight ≤ 30 kg |
| • Patient pregnant or lactating |
| • Child bearing potential (i.e. pre-menopausal woman who is not using a reliable method of contraception) |
| • Major surgery in past 48 hours (CABG, organ biopsy, puncture of non-compressible vessels), or scheduled for major surgery during the study period |
| • Involvement in another randomized drug trial |
| • Presence of a fever as defined by a temperature > 38.2°C |