Totally implantable subcutaneous port system versus central venous catheter placed before induction chemotherapy in patients with acute leukaemia-a randomized study.

A group of 43 adult patients with acute leukaemia (AL) were randomized to receive a double-lumen totally implantable subcutaneous port system (PORT, n=19) or a double-lumen central venous catheter (CVC, n=24) before induction chemotherapy. Six patients were excluded due to protocol violation ( n=4, CVC) and technical difficulties ( n=2, PORT). A standardized catheter record form was used for recording of catheter function, local infection and bleeding. The study was prematurely closed due to extensive subcutaneous bleeding after placement in five patients with a PORT. Intention to treat ( n=43) or per protocol (PP) analysis ( n=37) did not reveal a significant difference between the two groups with regard to catheter survival time (PP PORT, median 113 days, range 2-634 days; CVC, 55 days, 11-223 days). The number of positive blood cultures per 100 central venous access device days was significantly higher in the CVC group (median 3.6 per 100 days) than in the PORT group (0.9 per 100 days; P=0.02). In addition, the time to the first blood culture positive for coagulase-negative staphylococcus was shorter in the CVC group (median 14 days) than in the PORT group (52 days; P=0.02). Despite fewer infectious complications in the PORT group the use of a double-lumen CVC is advocated in patients with AL undergoing induction treatment due to the risk of extensive local bleeding after placement of the PORT.

RCT Entities:   Population Interventions Outcomes