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Pharmacologic and Mechanical Prophylaxis of Venous Thromboembolism Among Special Populations
Comparative Effectiveness Reviews, No. 116
Investigators: Sonal Singh, MD, MPH, Elliott R Haut, MD, FACS, Daniel J Brotman, MD, Ritu Sharma, BSc, Yohalakshmi Chelladurai, MBBS, MPH, Kenneth M Shermock, PharmD, PhD, Sosena Kebede, MD, MPH, Kent A Stevens, MD, MPH, Kalpana Rao Prakasa, MBBS, MS, Hasan M Shihab, MBChB, MPH, Tokunbo O Akande, MBBS, MPH, Amer M Zeidan, MBBS, Luis J Garcia, MD, and Jodi B Segal, MD, MPH.
Author Information and AffiliationsStructured Abstract
Background:
Venous thromboembolism (VTE) is a prevalent and avoidable complication of hospitalization. Patients hospitalized with trauma, traumatic brain injury, burns, or liver disease; patients on antiplatelet therapy; obese or underweight patients; those having obesity surgery; or with acute or chronic renal failure have unequal risks for bleeding and thrombosis and may benefit differently from prophylactic therapy medication.
Objectives:
To systematically review the comparative effectiveness and safety of pharmacological and mechanical methods of prophylaxis of VTE in these special populations.
Data sources:
We searched MEDLINE®, Embase®, SCOPUS, CINAHL®, www.clinicaltrials.gov, International Pharmaceutical Abstracts (IPA), and the Cochrane Library in July 2012. This was complemented by hand searches from the reference lists and unpublished studies provided by sponsors.
Review methods:
We included randomized controlled trials on these special populations. Since these populations may be excluded from trials, we also included controlled observational studies of pharmacologic agents, and uncontrolled observational studies and case series of inferior vena cava (IVC) filter use. Two reviewers evaluated studies for eligibility, serially abstracted data using standardized forms, and independently evaluated the risk of bias in the studies and strength of evidence for major outcomes and comparisons. We qualitatively synthesized the evidence and also pooled the relative risks from the controlled studies.
Results:
After a review of 30,902 unique citations, we included 101 studies of which just 6 were trials. The majority of observational studies had a high risk of bias. The strength of evidence is low that IVC filter placement is associated with a lower incidence of pulmonary embolism and fatal pulmonary embolism in hospitalized patients with trauma compared with no IVC filter placement. The strength of evidence is low that enoxaparin reduces deep vein thrombosis and that unfractionated heparin reduces mortality in patients with traumatic brain injury when compared with patients without anticoagulation. Low-grade evidence supports the idea that IVC filters with usual care are associated with increased mortality and do not decrease the risk of pulmonary embolism in patients undergoing bariatric surgery compared with usual care alone. All other comparisons, for all of the Key Questions, had insufficient evidence to permit conclusions.
Conclusions:
Our systematic review demonstrates that there is a paucity of high-quality evidence to inform treatment of these special populations. Future research using robust observational studies that control for confounding by indication and disease severity are needed as randomized controlled trials typically exclude or do not report on these populations.
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Results of the Search
- Description of Types of Studies Retrieved
- Key Question 1 What are the comparative effectiveness and safety of inferior vena cava filters to prevent pulmonary embolisms in hospitalized patients with trauma?
- Key Question 2a What are the comparative effectiveness and safety of pharmacological and mechanical strategies to prevent venous thromboembolism in hospitalized patients with traumatic brain injury?
- Key Question 2b What is the optimal timing of initiation and duration of pharmacologic prophylaxis to prevent venous thromboembolism in hospitalized patients with traumatic brain injury?
- Key Question 3 What are the comparative effectiveness and safety of pharmacologic and mechanical strategies to prevent venous thromboembolism in hospitalized patients with burns?
- Key Question 4 What are the comparative effectiveness and safety of pharmacologic and mechanical strategies to prevent VTE in hospitalized patients with liver disease?
- Key Question 5 What are the comparative effectiveness and safety of pharmacologic and mechanical strategies to prevent VTE in hospitalized patients receiving antiplatelet therapy?
- Key Question 6 What are the comparative effectiveness and safety of pharmacologic and mechanical strategies to prevent venous thromboembolism in hospitalized patients undergoing bariatric surgery?
- Key Question 7 What are the comparative effectiveness and safety of pharmacologic prophylaxis for prevention of venous thromboembolism during hospitalization of obese and underweight patients?
- Key Question 8 What are the comparative effectiveness and safety of pharmacologic prophylaxis for prevention of venous thromboembolism during hospitalization of patients with acute kidney injury, moderate renal impairment, or severe renal impairment not undergoing dialysis and patients receiving dialysis?
- Discussion
- References
- Appendix A Acronyms and Abbreviations
- Appendix B Detailed Search Strategies
- Appendix C Screening and Data Abstraction Forms
- Appendix D Excluded Studies
- Appendix E Evidence Tables
- Appendix F Scientific Information Packet Tables
- Appendix G Sensitivity Analysis for IVC Filters in Trauma on PE, Fatal PE, and Mortality in Controlled Studies
- Appendix H Sensitivity Analysis for KQ 1 and KQ 6
- Appendix I Clinical Trials
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2007-10061-I. Prepared by: Johns Hopkins University Evidence-based Practice Center, Baltimore, MD
Suggested citation:
Singh S, Haut ER, Brotman DJ, Sharma R, Chelladurai Y, Shermock KM, Kebede S, Stevens KA, Prakasa KR, Shihab HM, Akande TO, Zeidan AM, Garcia LJ, Segal JB. Pharmacologic and Mechanical Prophylaxis of Venous Thromboembolism Among Special Populations. Comparative Effectiveness Review No. 116. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-2007-10061-I.) AHRQ Publication No. 13-EHC082-1. Rockville, MD: Agency for Healthcare Research and Quality. May 2013. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
This report is based on research conducted by the Johns Hopkins University Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2007-10061-I). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services.
The information in this report is intended to help health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
- 1
540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
- Review The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis.[JAMA Surg. 2014]Review The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis.Haut ER, Garcia LJ, Shihab HM, Brotman DJ, Stevens KA, Sharma R, Chelladurai Y, Akande TO, Shermock KM, Kebede S, et al. JAMA Surg. 2014 Feb; 149(2):194-202.
- Review Venous Thromboembolism Prophylaxis in Orthopedic Surgery[ 2012]Review Venous Thromboembolism Prophylaxis in Orthopedic SurgerySobieraj DM, Coleman CI, Tongbram V, Lee S, Colby J, Chen WT, Makanji SS, Ashaye A, Kluger J, White CM. 2012 Mar
- Review A systematic review of venous thromboembolism prophylaxis strategies in patients with renal insufficiency, obesity, or on antiplatelet agents.[J Hosp Med. 2013]Review A systematic review of venous thromboembolism prophylaxis strategies in patients with renal insufficiency, obesity, or on antiplatelet agents.Kebede S, Prakasa KR, Shermock K, Shihab HM, Brotman DJ, Sharma R, Chelladurai Y, Haut ER, Singh S, Segal JB. J Hosp Med. 2013 Jul; 8(7):394-401. Epub 2013 Jun 12.
- Venous thromboembolism prophylaxis in patients with traumatic brain injury: a systematic review.[F1000Res. 2013]Venous thromboembolism prophylaxis in patients with traumatic brain injury: a systematic review.Chelladurai Y, Stevens KA, Haut ER, Brotman DJ, Sharma R, Shermock KM, Kebede S, Singh S, Segal JB. F1000Res. 2013; 2:132. Epub 2013 May 29.
- Role of prophylactic temporary inferior vena cava filters placed at the ICU bedside under intravascular ultrasound guidance in patients with multiple trauma.[J Vasc Surg. 2004]Role of prophylactic temporary inferior vena cava filters placed at the ICU bedside under intravascular ultrasound guidance in patients with multiple trauma.Rosenthal D, Wellons ED, Levitt AB, Shuler FW, O'Conner RE, Henderson VJ. J Vasc Surg. 2004 Nov; 40(5):958-64.
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