Normal saline versus heparin solution to lock totally implanted venous access devices: Results from a multicenter randomized trial

PURPOSE: Our aim was to determine the non-inferiority of normal saline flushing compared to heparin flushing in maintaining the patency of totally implanted venous access devices (TIVADs). METHOD: Four hundred and thirty patients were recruited from 14 Italian centres. Patients were randomized to heparin group or to normal saline group. The primary outcome of the study was TIVAD occlusion. RESULTS: After randomisation, 203 patients were assigned to normal saline group and 212 to heparin group. Median follow up time was 204 days in normal saline group and 294 in the heparin group. We observed 24 withdrawal occlusions (5.78%): 10 in the heparin group and 14 in the normal saline group. One total occlusion was observed in the normal saline group. Taking as reference the arm treated with heparin, the absolute risk difference was 2.67 with the 90% CI including the non - inferiority margin of 4%. No significant difference between hazards of occlusion was found. CONCLUSIONS: This study failed to demonstrate that normal saline flushing is not inferior to heparin flushing, even if a significant difference between the two treatments was not found. The use of heparin is controversial and other prospective trials are necessary in this field. TRIAL REGISTRATION: EudraCT number: 2009-013620-22.