Development of a clinical decision support tool to identify patients at high risk of early or late bleeding complications from anticoagulation

Development of a clinical decision support tool to identify patients at high risk of early or late bleeding complications from anticoagulation

None

Potential conflicts of interest will be disclosed when the research is presented and published.

The most important complication of anticoagulation is an increased risk of bleeding complications. These complications are most likely to occur early in the course of treatment, especially in the first 3 months. However, this risk persists, and varies from patient to patient. Previous studies have examined the accuracy of simple point scores such as the Outpatient Bleeding Risk Index (1), ATRIA score (2), HAS-BLED score (3), and HEMORRHAGES score (4). However, they were largely developed in patients taking warfarin, and used standard multivariate techniques. Some have also not been found to be as accurate in subsequent studies.

Dabigatran is a new, widely used oral anticoagulant. It has the important advantages of a similar safety profile, better efficacy than warfarin for some conditions, and much greater ease of use by patients. We propose to evaluate the existing clinical decision rules for their ability to identify patients at increased risk of bleeding when placed on dabigatran. These patients could potentially benefit from closer monitoring, especially during the first 3 months of therapy.

We will also investigate novel approaches to developing clinical decision support tools such as classification and regression trees (CART) and artificial neural networks (ANN). These have the potential to more clearly identify patients at risk for bleeding complications. Thus our specific aims are:

1. Evaluate the accuracy of existing clinical decision rules for the prediction of bleeding complications in patients taking dabigatran or warfarin.
2. Develop new decision support tools using regression, CART and/or ANN methodologies.

We will summarize the findings in published research studies in peer reviewed medical journals. Each article will include the decision support tool in full, which will be available for use by clinicians and their patients. The results will help patients and their doctors identify who needs special monitoring to avoid bleeding complications.

1. Pisters R, Lane DA Nieuwlaat, et al. A novel user-friendly score (HAS-BLED) to assess 1 year risk of major bleeding in patients with atrial fibrillation: The Euro Heart Survey. Chest 2010; 138(5): 1093-1100. Also: J Am Coll Cardiol 2011; 57: 173-80.
2. Fang MC, et al. A new risk scheme to predict warfarin-associated hemorrhage: The ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) Study. J Am Coll Cardiol 2011; 58: 395-401
3. Wells PS, Forgie MA, Simms M, et al. The outpatient bleeding risk index: validation of a tool for predicting bleeding rates in patients treated for DVT and PE. Arch Intern Med 2003; 163: 917-20.
4. Gage BF, et al. Clinical classification schemes for predicting hemorrhage: Results from the National Registry of Atrial Fibrillation (NRAF). Am Heart J 2006; 151: 713-9

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Medicine: dabigatran etexilate, Condition: Venous Thromboembolism, Phase: 3, Clinical Study ID: 1160.63, Sponsor: Boehringer Ingelheim" },{ "PostingID": 2596, "Title": "BI-1160.47", "Description": "Secondary Prevention of Venous Thrombo Embolism (VTE).

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Medicine: dabigatran etexilate, Condition: Thromboembolism, Phase: 3, Clinical Study ID: 1160.46, Sponsor: Boehringer Ingelheim" },{ "PostingID": 2598, "Title": "BI-1160.53", "Description": "Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

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The publication citation will be added after the research is published.