CLINICAL-TRIAL OF PREVENTION OF DEEP-VEIN THROMBOSIS ON IMPLANTABLE INFUSION DEVICES BY A LOW-MOLECULAR-WEIGHT HEPARIN

We studied the effect of a fractionated heparin, Dalteparine Sodium, o n the prevention of thrombosis of Veins of the superior vena cava syst em catheterized by implantable infusion devices. Forty-six patients wi th solid or lympho-proliferative tumors, whose clinical condition requ ired installation of a such device, were successively included into th e study in 1991. The anticoagulant was administered for one month foll owing implantation at the dosage of 2500 anti-Xa units per day. The de velopment of deep vein thrombosis was investigated by systematic Doppl er ultrasound before the first and third months and at 1 year. Three e arly (D9, D12 and D16) and asymptomatic thrombosis were diagnosed (6,5 %). This rate, although clearly more favourable, was not significantly different (p = 0.254) from the rate of 15,2% previously reported in a group of 72 comparable patients, but who did not receive preventive t reatment. These results demonstrate the necessity and feasibility of a randomized study on a larger number of patients testing several proto cols, before concluding on the efficacy of this type of preventive tre atment.