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 |