Previous studies have suggested the utility of D-Dimer ELISA assays in eliminating a diagnosis of pulmonary embolism (PE). Our objectives were to evaluate the performance of a new, rapid, quantitative, and automated Liatest D-Dimer Assay in patients with suspected PE. Three hundred eighty-six consecutive patients referred to our institution between March 1992 and December 1996 for clinically suspected PE, with recent clinical signs not exceeding 1 wk, were included in this study. Diagnosis of PE was based on clinical evaluation, radionuclide lung imaging, lower limb examination, and, when required, pulmonary angiography. D-Dimer performances, for both Liatest D-Dimer and standard D-Dimer ELISA (Asserachrom DDi), assays, were assessed at the end of the study. Among the 386 patients tested, 146 (37.8%) were classified as PE-positive. Liatest D-Dimer assay had a 100% sensitivity (95% confidence interval, 97 to 100%) and a negative predictive value of 100% (95% confidence interval, 94 to 100%). A normal result, below the cutoff of 500 ng/ml, occurred in 83 of the 386 (21%) patients. There was a strong agreement between Liatest D-Dimer and Asserachrom DDi analyses. These findings suggest that this rapid, quantitative, and automated D-Dimer assay provides a useful diagnostic tool for the clinician with regard to exclusion of PE.
The benefit/risk ratio of administering heparin during spinal anaesthesia in patients undergoing total hip replacement (THR) has not been studied widely. We conducted a prospective, randomized, double-blind study to compare low molecular weight heparin (LMWH) for 10 days and placebo in patients undergoing THR performed under spinal anaesthesia associated with gradual compression stockings. Efficacy was assessed by systematic bilateral ascending venography on day 10 +/- 2 in a sequential analysis. Among the 170 patients enrolled, data were available in 153 patients. In the LMWH group (n = 78) the total incidence of deep vein thrombosis (DVT) was 14.1% compared with 37.3% in the placebo group (n = 75) (P = 0.0016). No gross neurological sequelae were observed during the study. This study showed that the addition of LMWH in patients undergoing THR under spinal anaesthesia and wearing gradual compression stockings significantly decreased the incidence of venogram-proved DVT.
Several studies have evaluated D-dimer, a fragment that is specific for the degradation of fibrin, 1 in patients with clinically suspected d e e p v e n o u s thrombosis (DVT).2 Because of their long half-lives, D-dimers provide a better choice than markers with shorter half-lives (thrombin-antithrombin complexes and prothrombin fragments 1 + 2) in evaluating the DVTs. Two D-dimer techniques are currently available: an e n z y m e l i n k e d -i m m u n o s o r b e n t assay (ELISA) or a latex agglutination assay. In preliminary studies, the ELISA assay has been reported to have very high sensitivity and moderate specificity. ELISA is the more widely used method. However, because it is time consuming, it is not well adapted for emergency testing; in addition, ELISA formatting is not usually suitable for individual testing. Studies involving latex testing for the measurement of Ddimer have frequently reported insufficient sensitivity for the exclusion of DVT. The purpose of the present study was to determine the performance of a new, quantitative and automated rapid D-dimer assay in the diagnosis of s u s p e c t e d DVT in a cohort of patients in whom symptoms had developed within 7 days before admission to the hospital. METHODS PatientsData for all patients with a possible diagnosis of DVT w h o were a d m i t t e d to the D e p a r t m e n t of Pneumology and Internal Medicine were collected prospectively on a register from March 1992 to June 1995. Recent clinical symptoms of DVT (onset less than 7 days) had to be present. The clinical suspicion of DVT occurred before hospitalization, so patients were referred for diagnosis, or during the first clinical 748
Objective: To compare oral anticoagulant treatment (fluindione) started on either the 1st or the 10th day of a low-molecular-weight heparin (enoxaparin) treatment for deep vein thrombosis confirmed by venography. Design: An open, multicenter, randomized study in two parallel treatment groups. Interventions: All patients received enoxaparin, 1 mg/kg s.c. twice daily, and oral fluindione, 20 mg once daily, either beginning on day 1 or on day 10 of the enoxaparin treatment. Enoxaparin was discontinued once the international normalized ratio under fluindione was stable between 2.0 and 3.0 over 2 days. Fluindione treatment was maintained during a 3-month follow-up period. Outcome Measurements: Specific examinations (venography and/or V/Q lung scanning and/or angiography) were performed only in the event of a clinically suspected recurrence of venous thromboembolism during the 3-month follow-up period. All cases were blindly assessed by an independent Reading Committee. Results: A clinically suspected venous thromboembolism was confirmed by objective tests in 1 of 223 patients (group of delayed introduction of fluindione; n = 111). Equivalence was demonstrated between the two treatment schedules (p < 0.0001) for a maximal difference of 10% (90% confidence interval: –2.42 to 0.58). The mean duration of hospitalization was significantly reduced (p = 0.0001) in the group with early introduction of fluindione. The incidence of hemorrhage was comparable between the two treatment groups. Conclusion: Early and delayed introduction of oral anticoagulant treatment in association with subcutaneous enoxaparin in patients with deep vein thrombosis was shown to be equivalent in preventing the recurrence of venous thromboembolism. In patients with early introduction of oral anticoagulant, hospitalization was significantly reduced.
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