BACKGROUND: Although well-established for suspected lower limb deep venous thrombosis, an algorithm combining a clinical decision score, d-dimer testing, and ultrasonography has not been evaluated for suspected upper extremity deep venous 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 clinical decision score, d-dimer testing, and ultrasonography. Patients were first categorized 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 of symptomatic UEDVT and pulmonary embolism in patients with a normal diagnostic work-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-dimer levels excluded UEDVT. Superficial venous thrombosis and UEDVT were diagnosed in 54 (13%) and 103 (25%) patients, respectively. All 249 patients with a normal diagnostic work-up, including those with protocol violations (n = 16), were followed for 3 months. One patient developed UEDVT during follow-up, for an overall 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, and ultrasonography can safely and effectively exclude UEDVT. If confirmed by other studies, 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 / Kleinjan, A; Di Nisio, M; Beyer-Westendorf, J; Camporese, G; Cosmi, B; Ghirarduzzi, A; Kamphuisen, Pw; Otten, Hm; Porreca, E; Aggarwal, A; Brodmann, M; Guglielmi, Md; Iotti, M; Kaasjager, K; Kamvissi, V; Lerede, T; Marschang, P; Meijer, K; Palareti, G; Rickles, Fr; Righini, M; Rutjes, A; Tonello, C; Verhamme, P; Werth, S; van Wissen, S; Büller, Hr. - In: ANNALS OF INTERNAL MEDICINE. - ISSN 0003-4819. - 160:7(2014), pp. 451-457. [10.7326/M13-2056]

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

Abstract

BACKGROUND: Although well-established for suspected lower limb deep venous thrombosis, an algorithm combining a clinical decision score, d-dimer testing, and ultrasonography has not been evaluated for suspected upper extremity deep venous 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 clinical decision score, d-dimer testing, and ultrasonography. Patients were first categorized 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 of symptomatic UEDVT and pulmonary embolism in patients with a normal diagnostic work-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-dimer levels excluded UEDVT. Superficial venous thrombosis and UEDVT were diagnosed in 54 (13%) and 103 (25%) patients, respectively. All 249 patients with a normal diagnostic work-up, including those with protocol violations (n = 16), were followed for 3 months. One patient developed UEDVT during follow-up, for an overall 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, and ultrasonography can safely and effectively exclude UEDVT. If confirmed by other studies, this algorithm has potential as a standard approach to suspected UEDVT. PRIMARY FUNDING SOURCE: None.
160
7
451
457
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 / Kleinjan, A; Di Nisio, M; Beyer-Westendorf, J; Camporese, G; Cosmi, B; Ghirarduzzi, A; Kamphuisen, Pw; Otten, Hm; Porreca, E; Aggarwal, A; Brodmann, M; Guglielmi, Md; Iotti, M; Kaasjager, K; Kamvissi, V; Lerede, T; Marschang, P; Meijer, K; Palareti, G; Rickles, Fr; Righini, M; Rutjes, A; Tonello, C; Verhamme, P; Werth, S; van Wissen, S; Büller, Hr. - In: ANNALS OF INTERNAL MEDICINE. - ISSN 0003-4819. - 160:7(2014), pp. 451-457. [10.7326/M13-2056]
Kleinjan, A; Di Nisio, M; Beyer-Westendorf, J; Camporese, G; Cosmi, B; Ghirarduzzi, A; Kamphuisen, Pw; Otten, Hm; Porreca, E; Aggarwal, A; Brodmann, M; Guglielmi, Md; Iotti, M; Kaasjager, K; Kamvissi, V; Lerede, T; Marschang, P; Meijer, K; Palareti, G; Rickles, Fr; Righini, M; Rutjes, A; Tonello, C; Verhamme, P; Werth, S; van Wissen, S; Büller, Hr
File in questo prodotto:
File Dimensione Formato  
2014_Kleinjan-Rutjes_AnnInternMed.pdf

Riservato

Dimensione 138.91 kB
Formato Adobe PDF
138.91 kB Adobe PDF   Visualizza/Apri   Richiedi una copia
Pubblicazioni consigliate

Caricamento pubblicazioni consigliate

Licenza Creative Commons
I metadati presenti in IRIS UNIMORE sono rilasciati con licenza Creative Commons CC0 1.0 Universal, mentre i file delle pubblicazioni sono rilasciati con licenza Attribuzione 4.0 Internazionale (CC BY 4.0), salvo diversa indicazione.
In caso di violazione di copyright, contattare Supporto Iris

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11380/1286623
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 60
  • ???jsp.display-item.citation.isi??? ND
social impact