Ionic implantation of silicone chronic venous access devices does not alter thrombotic complications: A double-blinded, randomized clinical trial

Background, ion implantation of silicone vascular catheters has been shown in preclinical and pilot studies to alter the thrombogenicity of silicone s urfaces through the reduced adherence of thrombin. This prospective, random ized double-blinded study was designed to detect differences in function re lated to thrombotic events between ion-implanted and standard silicone chro nic ve nous access devices (CVAD) placed in patients with cancer who are re ceiving chemotherapy. Methods. Patients with nonleukemic malignancies who required venous access for chemotherapy and who were not receiving anticoagulants were randomized to receive standard or ion-implanted CVAD. Postoperative functional assessm ents of the ease of infusion or aspiration were performed by oncology nurse s caring for the patients. Results. Follow-up, available for 100 of 106 randomized patients, showed mo re episodes of occlusion to aspiration in the ion implantation group (47%) than in the control group (39%) but this difference was not significant. Th ere were no significant differences between the 2 groups in the number occl usions when anticoagulation or local thrombolytic therapy was required nor were there differences in the numbers of infection or deep venous thrombose s. Conclusions, Ion implantation of silicone catheter material does not alter the incidence of local thrombotic complications of CVAD. Although there wer e no serious complications resulting from this treatment, the use of ion-im planted catheters cannot be recommended on the basis of this trial.