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Negative d-dimer Result To Exclude Recurrent Deep Venous Thrombosis: A Management Trial

Suman W. Rathbun, MD, MS; Thomas L. Whitsett, MD; and Gary E. Raskob, PhD
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From University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.

Acknowledgments: The authors thank Kevin Dahlin, Kyle Enfield, Janette Epperly, Jay Heath, Brenda Holliefield, Cindy Jones, Peggy Powell, and Penny Razo-Mosier for their assistance with this project.

Grant Support: By an Oklahoma Center for the Advancement of Science and Technology (OCAST) Health Research Grant (HR0-052) and in part by a National Institutes of Health, National Heart, Lung, and Blood Institute Research Career Training Award (K23) (HL04200-03). STA-Liatest d-dimer reagents were provided by Diagnostica Stago.

Potential Financial Conflicts of Interest:Grants received: S.W. Rathbun (Diagnostica Stago); Other: S.W. Rathbun (reagents for d-dimer were provided by Diagnostica Stago).

Requests for Single Reprints: Suman W. Rathbun, MD, Department of Medicine, WP 3120, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, Oklahoma City, OK 73104; e-mail, suman-rathbun@ouhsc.edu.

Current Author Addresses: Drs. Rathbun and Whitsett: Department of Medicine, WP 3120, University of Oklahoma Health Sciences Center, 920 Stanton L. Young Boulevard, Oklahoma City, OK 73104.

Dr. Raskob: University of Oklahoma Health Sciences Center, College of Public Health, 801 Northeast 13th Street, Room 139, Oklahoma City, OK 73104.

Author Contributions: Conception and design: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Analysis and interpretation of the data: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Drafting of the article: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Critical revision of the article for important intellectual content: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Final approval of the article: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Provision of study materials or patients: S.W. Rathbun, T.L. Whitsett.

Statistical expertise: G.E. Raskob.

Obtaining of funding: S.W. Rathbun.

Administrative, technical, or logistic support: S.W. Rathbun.

Collection and assembly of data: S.W. Rathbun, T.L. Whitsett, G.E. Raskob.

Ann Intern Med. 2004;141(11):839-845. doi:10.7326/0003-4819-141-11-200412070-00007
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In patients with suspected recurrent DVT, an automated assay for d-dimer, the STA-Liatest d-di, when used alone, may provide a simple method for excluding acute recurrent DVT. There was a low incidence (0.75% [CI, 0.02% to 4.09%]) of confirmed symptomatic venous thromboembolism after 3 months of follow-up in patients with a negative d-dimer result at presentation. The STA-Liatest d-di assay result was negative at presentation in 45% of patients (CI, 39.0% to 50.5%), providing a high clinical utility in avoiding the need for additional diagnostic testing and heparin treatment. The cost to the third-party payer for the STA-Liatest d-di assay is approximately $20; ultrasonography usually costs more than $200.

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Grahic Jump Location
Study protocol for patients with suspected recurrent deep venous thrombosis (DVT).

LMWH = low-molecular-weight heparin; PE = pulmonary embolism.

Grahic Jump Location




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Diagnosing a first venous thrombosis or a recurrent event: discrepancies in the role of D-dimer. Sho
Posted on January 18, 2005
José R Paño-Pardo
Internal Medicine Department. Hospital Universtario La Paz
Conflict of Interest: None Declared

Diagnosing recurrent deep vein thrombosis (DVT) is challenging for the clinician due to the absence of accurate tests. Rathbun et al1 (December 7th issue) propose a sole negative D-dimer (DD) test as a safe tool to rule out diagnosis of recurrent DVT. This conclusion apparently opposes the principles used to diagnose a suspected first episode of DVT. In this case, it is widely believed that a negative DD test may safely exclude the diagnosis just when the clinical pretest probability of DVT, as assessed by validated clinical models, is low2,3. Over 5% of patients with clinically estimated moderate probability and a negative DD test have DVT2. In this case a sole negative DD testing is not sufficient to rule out the diagnosis. On the other hand, in the cohort of patients described by Rathbun, in which the prevalence of DVT in patients with a negative DD test is probably up to 6%, DD testing is recommended as an isolated tool to exclude the diagnosis when negative.

Two different attitudes when facing the same disease with the same diagnostic tool (same false negative ratio). Is there any reason for these discordant messages? The absence of adequate tools for diagnosis of acute thrombosis when there is prior history of DVT may be an important factor to be considered. Nevertheless we believe that, considering the potential outcome of non diagnosed acute DVT, a more thorough diagnostic approach with compression ultrasonography is needed routinely in these patients. The issue is probably to improve its performance. Perphaps routine compression ultrasonography several months after a first episode of DVT would contribute to solve this problem, at least in patients in which rethrombosis is suspected not immediately after the initial episode.

1. Rathbun SW, Whitsett TL, Raskob GE. Negative D-dimer result to exclude recurrent deep venous thrombosis: a management trial. Ann Intern Med. 2004;141(11):839-45.

2. Kearon C, Ginsberg JS, Douketis J, et al. Management of suspected deep venous thrombosis in outpatients by using clinical assessment and D- dimer testing. Ann Intern Med 2001;135:108-11.

3. Wells PS, Anderson DR, Rodger M, et al. Evaluation of-Dimer in the Diagnosis of Suspected Deep-Vein Thrombosis. N Engl J Med 2003;349:1227- 35.

Conflict of Interest:

None declared

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Summary for Patients

Diagnosis of Suspected Recurrent Deep Venous Thrombosis Using d-Dimer and Compression Ultrasonography

The summary below is from the full report titled “Negative d-Dimer Result To Exclude Recurrent Deep Venous Thrombosis: A Management Trial.” It is in the 7 December 2004 issue of Annals of Internal Medicine (volume 141, pages 839-845). The authors are S.W. Rathbun, T.L. Whitsett, and G.E. Raskob.


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