BACKGROUND: Although well-established for suspected lower limb deep venousthrombosis, an algorithm combining a clinical decision score, d-dimer testing,and ultrasonography has not been evaluated for suspected upper extremity deepvenous thrombosis (UEDVT).OBJECTIVE: To assess the safety and feasibility of a new diagnostic algorithm in patients with clinically suspected UEDVT.DESIGN: Diagnostic management study. (ClinicalTrials.gov: NCT01324037) SETTING:16 hospitals in Europe and the United States.PATIENTS: 406 inpatients and outpatients with suspected UEDVT.MEASUREMENTS: The algorithm consisted of the sequential application of a clinicaldecision score, d-dimer testing, and ultrasonography. Patients were firstcategorized as likely or unlikely to have UEDVT; in those with an unlikely score and normal d-dimer levels, UEDVT was excluded. All other patients had (repeated) compression ultrasonography. The primary outcome was the 3-month incidence ofsymptomatic UEDVT and pulmonary embolism in patients with a normal diagnosticwork-up.RESULTS: The algorithm was feasible and completed in 390 of the 406 patients(96%). In 87 patients (21%), an unlikely score combined with normal d-dimerlevels excluded UEDVT. Superficial venous thrombosis and UEDVT were diagnosed in 54 (13%) and 103 (25%) patients, respectively. All 249 patients with a normaldiagnostic work-up, including those with protocol violations (n = 16), werefollowed for 3 months. One patient developed UEDVT during follow-up, for anoverall failure rate of 0.4% (95% CI, 0.0% to 2.2%).LIMITATIONS: This study was not powered to show the safety of the substrategies. d-Dimer testing was done locally.CONCLUSION: The combination of a clinical decision score, d-dimer testing, andultrasonography can safely and effectively exclude UEDVT. If confirmed by otherstudies, this algorithm has potential as a standard approach to suspected UEDVT.PRIMARY FUNDING SOURCE: None.
Safety and feasibility of a diagnostic algorithm combining clinical probability, d-dimer testing, and ultrasonography for suspected upper extremity deep venous thrombosis: a prospective management study
Rutjes A;
2014-01-01
Abstract
BACKGROUND: Although well-established for suspected lower limb deep venousthrombosis, an algorithm combining a clinical decision score, d-dimer testing,and ultrasonography has not been evaluated for suspected upper extremity deepvenous thrombosis (UEDVT).OBJECTIVE: To assess the safety and feasibility of a new diagnostic algorithm in patients with clinically suspected UEDVT.DESIGN: Diagnostic management study. (ClinicalTrials.gov: NCT01324037) SETTING:16 hospitals in Europe and the United States.PATIENTS: 406 inpatients and outpatients with suspected UEDVT.MEASUREMENTS: The algorithm consisted of the sequential application of a clinicaldecision score, d-dimer testing, and ultrasonography. Patients were firstcategorized as likely or unlikely to have UEDVT; in those with an unlikely score and normal d-dimer levels, UEDVT was excluded. All other patients had (repeated) compression ultrasonography. The primary outcome was the 3-month incidence ofsymptomatic UEDVT and pulmonary embolism in patients with a normal diagnosticwork-up.RESULTS: The algorithm was feasible and completed in 390 of the 406 patients(96%). In 87 patients (21%), an unlikely score combined with normal d-dimerlevels excluded UEDVT. Superficial venous thrombosis and UEDVT were diagnosed in 54 (13%) and 103 (25%) patients, respectively. All 249 patients with a normaldiagnostic work-up, including those with protocol violations (n = 16), werefollowed for 3 months. One patient developed UEDVT during follow-up, for anoverall failure rate of 0.4% (95% CI, 0.0% to 2.2%).LIMITATIONS: This study was not powered to show the safety of the substrategies. d-Dimer testing was done locally.CONCLUSION: The combination of a clinical decision score, d-dimer testing, andultrasonography can safely and effectively exclude UEDVT. If confirmed by otherstudies, this algorithm has potential as a standard approach to suspected UEDVT.PRIMARY FUNDING SOURCE: None.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
