End Points in Studies on the Prevention of Deep Vein Thrombosis

Sonaglia, Francesco; Rossi, Romina; Agnelli, Giancarlo

doi:10.1055/s-2001-12850

Cited by 6 publications

(2 citation statements)

References 27 publications

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“…The large disparity between the incidence of venographically detected DVT and clinically overt thromboembolic events shows that many asymptomatic DVT never become clinically apparent 32,33,40 . Dahl and Bergqvist 28 deemed short‐term, in‐hospital venographic endpoint studies aimed at demonstrating the superiority of one prophylactic regimen over another to be of questionable use.…”

Section: Determining the Efficacy Of Venous Thromboembolism Prophylaxismentioning

confidence: 99%

“…Dahl and Bergqvist 28 deemed short‐term, in‐hospital venographic endpoint studies aimed at demonstrating the superiority of one prophylactic regimen over another to be of questionable use. The uncertainty about the clinical relevance of asymptomatic DVT 3,32,33,40 has led numerous authors and expert societies to recommend that clinically relevant endpoints be used in the evaluation and comparison of pharmacological agents 2,8,33,35,40–43 …”

Section: Determining the Efficacy Of Venous Thromboembolism Prophylaxismentioning

confidence: 99%

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The Design of Venous Thromboembolism Prophylaxis Trials: Is Enoxaparin More Effective Than Fondaparinux?

Lalourcey¹

2003

Int J Clinical Practice

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SUMMARYThe aim of thromboprophylaxis is to minimise the incidence of clinically relevant venous thromboembolism (VTE) but in many trials designed to determine the efficacy of thromboprophylactic agents, asymptomatic VTE is included in the primary endpoint. Since asymptomatic events occur much more frequently than symptomatic events, they dominate the results. Data from trials comparing the thromboprophylactic efficacy of enoxaparin and fondaparinux in orthopaedic surgical patients are used to demonstrate that asymptomatic and symptomatic endpoints may yield different conclusions. There was no difference between these agents in the incidence of symptomatic VTE. Efficacy and safety results of thromboprophylactic studies are affected by other aspects of trial design such as the dose of each agent and the timing of treatment initiation and endpoint assessment. Such factors should be considered when designing clinical trials and evaluating their results.

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Section: Determining the Efficacy Of Venous Thromboembolism Prophylaxismentioning

confidence: 99%

Section: Determining the Efficacy Of Venous Thromboembolism Prophylaxismentioning

confidence: 99%

The Design of Venous Thromboembolism Prophylaxis Trials: Is Enoxaparin More Effective Than Fondaparinux?

Lalourcey¹

2003

Int J Clinical Practice

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Prophylaxis Against Thromboembolism in Spinal Surgery

Vieweg

2023

Manual of Spine Surgery

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Clinically important deep vein thrombosis in the intensive care unit: a survey of intensivists

et al. 2004

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IntroductionOutside the intensive care unit (ICU), clinically important deep vein thrombosis (DVT) is usually defined as a symptomatic event that leads to objective radiologic confirmation and subsequent treatment. The objective of the present survey is to identify the patient factors and radiologic features of lower limb DVT that intensivists consider more or less likely to make a DVT clinically important in ICU patients.MethodsOur definition of clinically important DVT was a DVT likely to result in short-term or long-term morbidity or mortality if left untreated, as opposed to a DVT that is unlikely to have important consequences. We asked respondents to indicate the likelihood that patient factors and ultrasonographic features make a DVT clinically important using a five-point scale (from 1 = much less likely to 5 = much more likely).ResultsOf the 71 Canadian intensivists who responded, 70 (99%) rated three patient factors as most likely to make a DVT clinically important: clinical suspicion of pulmonary embolism (mean score 4.6), acute or chronic cardiopulmonary morbidity that might limit a patient's ability to tolerate pulmonary embolism (score 4.5), and leg symptoms (score 4.2). Of the ultrasound features, proximal (score 4.7), large (score 4.2), and totally occlusive (score 3.9) thrombi were considered the three most important.ConclusionWhen labeling a DVT as clinically important, intensivists rely on different patient specific factors and thrombus characteristics than are used to assess the clinical importance of DVT outside the ICU. The clinical importance of DVT is influenced by unique factors such as cardiopulmonary reserve among mechanically ventilated patients.

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End Points in Studies on the Prevention of Deep Vein Thrombosis

Cited by 6 publications

References 27 publications

The Design of Venous Thromboembolism Prophylaxis Trials: Is Enoxaparin More Effective Than Fondaparinux?

The Design of Venous Thromboembolism Prophylaxis Trials: Is Enoxaparin More Effective Than Fondaparinux?

Prophylaxis Against Thromboembolism in Spinal Surgery

Clinically important deep vein thrombosis in the intensive care unit: a survey of intensivists

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