Heparin Study in Internal Medicine (HESIM): design and preliminary results

Abstract

The Heparin Study in Internal Medicine (HESIM) compares the efficacy and safety of an unfractionated (UF) heparin with a low molecular weight (LMW) heparin (CY 216 D) for prevention of proximal deep vein thrombosis (DVT) and pulmonary embolism (PE) in medical inpatients with a high risk for development of thromboembolism. Patients are randomized and receive three times daily 5000 IU UF heparin or once daily 3100 IU LMW heparin and two placebo injections subcutaneously for 10 days. All patients are screened for the presence of proximal DVT at day 1 and 10 by real-time B-mode compression sonography and for PE by repeated clinical examinations. Perfusion scintigraphy is used for confirmation of the clinical diagnosis of PE. The study protocol includes a stratified randomization of patients on admission to the hospital according to one of the following main diagnoses: malignant disease, cardiovascular disease, bronchopulmonary disease, neurologic disease, and other diseases. The present study may serve as a model for further clinical trials in medical inpatients using the biometric approach of statistical analysis for proving equivalence of drug efficacy, and to adopt less sensitive but noninvasive methods for the detection of primary endpoints.