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Table 1 Study inclusion and exclusion criteria

From: Prevention of catheter lumen occlusion with rT-PA versus heparin (Pre-CLOT): study protocol of a randomized trial [ISRCTN35253449]

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