Detailed assessment of benefits and risks of retrievable inferior vena cava filters on patients with complicated injuries: The da Vinci multicentre randomised controlled trial study protocol

BMJ Open

Volumn 7, Issue 7, 2017, Pages

  Ho, Kwok M ^a,b,c   Rao, Sudhakar ^a   Honeybul, Stephen ^d   Zellweger, Rene ^a   Wibrow, Bradley ^d   Lipman, Jeffrey ^e   Holley, Anthony ^e   Kop, Alan ^a   Geelhoed, Elizabeth ^b   Corcoran, Tomas ^f  

^a ROYAL PERTH HOSPITAL   (Australia)

^b UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

^c MURDOCH UNIVERSITY   (Australia)

^d SIR CHARLES GAIRDNER HOSPITAL   (Australia)

^e UNIVERSITY OF QUEENSLAND   (Australia)

^f UNIVERSITY OF WESTERN AUSTRALIA   (Australia)

Author keywords

adult intensive and critical care; thromboembolism; trauma management

Indexed keywords

ANTICOAGULANT AGENT;

ARTICLE; AUTOPSY; CONTROLLED STUDY; COST BENEFIT ANALYSIS; COST EFFECTIVENESS ANALYSIS; HOSPITAL MORTALITY; HOSPITAL PATIENT; HUMAN; INJURY; INJURY SCALE; INTENSIVE CARE UNIT; LENGTH OF STAY; LUNG ANGIOGRAPHY; LUNG EMBOLISM; LUNG VENTILATION PERFUSION RATIO; MULTICENTER STUDY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; THROMBOSIS PREVENTION; TRANSESOPHAGEAL ECHOCARDIOGRAPHY; TREATMENT CONTRAINDICATION; VENA CAVA FILTER; VENOUS THROMBOEMBOLISM; COMPLICATION; METHODOLOGY; MULTICENTER STUDY (TOPIC); RANDOMIZED CONTROLLED TRIAL (TOPIC);

HUMANS; MULTICENTER STUDIES AS TOPIC; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; RISK ASSESSMENT; VENA CAVA FILTERS; VENOUS THROMBOEMBOLISM; WOUNDS AND INJURIES;

EID: 85024406936     PISSN: None     EISSN: 20446055     Source Type: Journal    
DOI: 10.1136/bmjopen-2017-016747     Document Type: Article

References (64)

1. Galson SK. The Surgeon General's Call to Action to Prevent Deep Vein Thrombosis andPulmonary Embolism. https://www. ncbi. nlm. nih. gov/ books/ NBK44178/
2. National Quality Forum. National Voluntary Consensus Standards for Prevention and Care of venous thromboembolism: additional performance measures, 2008. http://www. qualityforum. org/ Publications/ 2008/ 10/ National- Voluntary- Consensus- Standards- for- prevention- and- Care- of- Venous- Thromboembolism-- Additional- Performance- Measures. aspx
3. The burden of venous thromboembolism in Australia. Report by Access Economics Pty Limited for the Australian and New Zealand Working Party on the management andprevention of venous thromboembolism in Australia, 2008. https://www. deloitteaccesseconomics. com. au/ uploads/ File/ The% 20burden% 20of% 20VTE% 20in% 20Australia. pdf
4. Cohen AT, Agnelli G, Anderson FA, et al. Venous thromboembolism (VTE) in Europe. the number of VTE events and associated morbidity and mortality. Thromb Haemost 2007;98:756-64.
5. Cohen AT. The burden of venous thromboembolism in the hospital setting. Pathophysiol Haemost Thromb 2009-2010:102.
6. Cohen AT, Tapson VF, Bergmann JF, et al. Venous thromboembolism risk and prophylaxis in the acute hospital care setting (ENDORSE study): a multinational cross-sectional study. Lancet 2008;371:387-94.
7. Cohen AT. Prevention of postoperative venous thromboembolism. BMJ 2009;339:b4477.
8. Schultz DJ, Brasel KJ, Washington L, et al. Incidence of asymptomatic pulmonary embolism in moderately to severely injured trauma patients. J Trauma 2004;56:727-33.
9. Cook DJ, Crowther MA. Thromboprophylaxis in the intensive care unit: focus on medical-surgical patients. Crit Care Med 2010;38:S76-S82.
10. Geerts WH, Bergqvist D, Pineo GF. Prevention of venous thromboembolism:American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8thEdition)., 2008:133, 381S-453.
11. Joint Commission International. Venous thromboembolism (VTE) measures. https://www. jointcommission. org/ venous- thromboembolism/
12. Kakkar AK, Davidson BL, Haas SK; Investigators Against Thromboembolism (INATE) Core Group. Compliance with recommended prophylaxis for venous thromboembolism: improving the use and rate of uptake of clinical practice guidelines. J Thromb Haemost 2004;2:221-7.
13. Ginzburg E, Dujardin F. Physicians' perceptions of the definition of Major bleeding in Major orthopedic surgery: results of an international survey. J Thromb Thrombolysis 2011;31:188-95.
14. Tapson VF, Decousus H, Pini M, et al. Venous thromboembolism prophylaxis in acutely ill hospitalized medical patients: findings from the International Medical Prevention Registry on venous thromboembolism. Chest 2007;132:936-45.
15. Steele N, Dodenhoff RM, Ward AJ, et al. Thromboprophylaxis in pelvic and acetabular trauma surgery. the role of early treatment with low-molecular-weight heparin. J Bone Joint Surg Br 2005;87:209-12.
16. Nathens AB, McMurray MK, Cuschieri J, et al. The practice of venous thromboembolism prophylaxis in the Major trauma patient. J Trauma 2007;62:557-63.
17. Lilly CM, Liu X, Badawi O, et al. Thrombosis prophylaxis and mortality risk among critically ill adults. Chest 2014;146:51-7.
18. Ho KM, Chavan S, Pilcher D. Omission of early thromboprophylaxis and mortality in critically ill patients: a multicenter registry study. Chest 2011;140:1436-46.
19. Ho KM, Litton E. Venous thromboembolism prophylaxis in hospitalized elderly patients: time to consider a 'MUST' strategy. J Geriatr Cardiol 2011;8:114-20.
20. Kakkos SK, Caprini JA, Geroulakos G, et al. Combined intermittent pneumatic leg compression and pharmacological prophylaxis for prevention of venous thromboembolism. Cochrane Database Syst Rev 2016;9:CD005258.
21. Eldridge D. Injury among young Australians. Bulletin 60: AIHW, 2008. http://www. aihw. gov. au/ WorkArea/ DownloadAsset. aspx? id= 6442452801
22. Guyatt GH, Akl EA, Crowther M, et al. American College of Chest PhysiciansAntithrombotic Therapy and Prevention of Thrombosis Panel. Executive summary:Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College ofChest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141(2 Suppl):7S-47.
23. Paciaroni M, Ageno W, Agnelli G. Prevention of venous thromboembolism after acute spinal cord injury with low-dose heparin or low-molecular-weight heparin. Thromb Haemost 2008;99:978-80.
24. Rosenthal D, McKinsey JF, Levy AM, et al. Use of the Greenfield filter in patients with Major trauma. Cardiovasc Surg 1994;2:52-5.
25. Bandle J, Shackford SR, Sise CB, et al. Variability is the standard: the management of venous thromboembolic disease following trauma. J Trauma Acute Care Surg 2014;76:213-6.
26. Shackford SR, Cook A, Rogers FB, et al. The increasing use of vena cava filters in adult trauma victims: data from the American College of Surgeons National Trauma Data Bank. J Trauma 2007;63:764-9.
27. Kaufman JA, Kinney TB, Streiff MB, et al. Guidelines for the use of retrievable and convertible vena cava filters: report from the Society of Interventional Radiology multidisciplinary consensus conference. Surg Obes Relat Dis 2006;2:200-12.
28. Sing RF, Rogers FB, Novitsky YW, et al. Optional vena cava filters for patients with high thromboembolic risk: questions to be answered. Surg Innov 2005;12:195-202.
29. Rogers FB, Strindberg G, Shackford SR, et al. Five-year follow-up of prophylactic vena cava filters in high-risk trauma patients. Arch Surg 1998;133:406-11.
30. Stawicki SP, Sims CA, Sharma R, et al. Vena cava filters: a synopsis of complications and related topics. J Vasc Access 2008;9:102-10.
31. Cherry RA, Nichols PA, Snavely TM, et al. Prophylactic inferior vena cava filters: do they make a difference in trauma patients? J Trauma 2008;65:544-8.
32. Young T, Tang H, Aukes J, et al. Vena caval filters for the prevention of pulmonary embolism. Cochrane Database Syst Rev 2007;4:CD006212.
33. Chiasson TC, Manns BJ, Stelfox HT. An economic evaluation of venous thromboembolism prophylaxis strategies in critically ill trauma patients at risk of bleeding. PLoS Med 2009;6:e1000098.
34. Rajasekhar A, Lottenberg L, Lottenberg R, et al. A pilot study on the randomization of inferior vena cava filter placement for venous thromboembolism prophylaxis in high-risk trauma patients. J Trauma 2011;71:323-9.
35. Haut ER, Garcia LJ, Shihab HM, et al. The effectiveness of prophylactic inferior vena cava filters in trauma patients: a systematic review and meta-analysis. JAMA Surg 2014;149:194-202.
36. Knudson MM, Ikossi DG, Khaw L, et al. Thromboembolism after trauma: an analysis of 1602 episodes from the American College of Surgeons National Trauma Data Bank. Ann Surg 2004;240:490-6.
37. Smouse B, Johar A. Is market growth of vena cava filters justified? A review of indications, use, and market analysis. Endovascular Today 2010:74-7.
38. Hope WW, Demeter BL, Newcomb WL, et al. Postoperative pulmonary embolism: timing, diagnosis, treatment, and outcomes. Am J Surg 2007;194:814-9.
39. Stefanidis D, Paton BL, Jacobs DG, et al. Extended interval for retrieval of vena cava filters is safe and may maximize protection against pulmonary embolism. Am J Surg 2006;192:789-94.
40. Sing RF, Camp SM, Heniford BT, et al. Timing of pulmonary emboli after trauma: implications for retrievable vena cava filters. J Trauma 2006;60:732-5.
41. Karmy-Jones R, Jurkovich GJ, Velmahos GC, et al. Practice patterns and outcomes of retrievable vena cava filters in trauma patients: an AAST multicenter study. J Trauma 2007;62:17-25.
42. Ho KM, Tan JA, Burrell M, et al. Venous thrombotic, thromboembolic, and mechanical complications after retrievable inferior vena cava filters for Major trauma. Br J Anaesth 2015;114:63-9.
43. Scales DC, Riva-Cambrin J, Wells D, et al. Prophylactic anticoagulation to prevent venous thromboembolism in traumatic intracranial hemorrhage: a decision analysis. Crit Care 2010;14:R72.
44. Arnold JD, Dart BW, Barker DE, et al. Gold medal Forum winner. unfractionated heparin three times a day versus enoxaparin in the prevention of deep vein thrombosis in trauma patients. Am Surg 2010;76:563-70.
45. Kurtoglu M, Yanar H, Bilsel Y, et al. Venous thromboembolism prophylaxis after head and spinal trauma: intermittent pneumatic compression devices versus low molecular weight heparin. World J Surg 2004;28:807-11.
46. Eppsteiner RW, Shin JJ, Johnson J, et al. Mechanical compression versus subcutaneous heparin therapy in postoperative and posttrauma patients: a systematic review and meta-analysis. World J Surg 2010;34:10-19.
47. Latronico N, Berardino M. Thromboembolic prophylaxis in head trauma and multiple-trauma patients. Minerva Anestesiol 2008;74:543-8.
48. Mismetti P, Rivron-Guillot K, Quenet S, et al. A prospective long-term study of 220 patients with a retrievable vena cava filter for secondary prevention of venous thromboembolism. Chest 2007;131:223-9.
49. Berber O, Vasireddy A, Nzeako O, et al. The high-risk polytrauma patient and inferior vena cava filter use. Injury 2017. pii:;48:1400-4.
50. Sarosiek S, Rybin D, Weinberg J, et al. Association between Inferior Vena Cava Filter insertion in Trauma Patients and In-Hospital and overall mortality. JAMA Surg 2017;152:75-81.
51. Rogers FB, Cipolle MD, Velmahos G, et al. Practice management guidelines for the prevention of venous thromboembolism in trauma patients: the EAST practice management guidelines work group. J Trauma 2002;53:142-64.
52. Knudson MM, Lewis FR, Clinton A, et al. Prevention of venous thromboembolism in trauma patients. J Trauma 1994;37:480-7.
53. Khansarinia S, Dennis JW, Veldenz HC, et al. Prophylactic Greenfield filter placement in selected high-risk trauma patients. J Vasc Surg 1995;22:231-6.
54. Ho KM, Burrell M, Rao S, et al. Incidence and risk factors for fatal pulmonary embolism after Major trauma: a nested cohort study. Br J Anaesth 2010;105:596-602.
55. Ho KM, Burrell M, Rao S. Extracranial injuries are important in determining mortality of neurotrauma. Crit Care Med 2010;38:1562-8.
56. Ho KM, Chavan S. Prevalence of thrombocytosis in critically ill patients and its association with symptomatic acute pulmonary embolism. A multicentre registry study. Thromb Haemost 2013;109:272-9.
57. Rogers FB, Shackford SR, Horst MA, et al. Determining venous thromboembolic risk assessment for patients with trauma: the Trauma Embolic Scoring System. J Trauma Acute Care Surg 2012;73:511-5.
58. Ho KM, Rao S, Rittenhouse KJ, et al. Use of the Trauma Embolic Scoring System (TESS) to predict symptomatic deep vein thrombosis and fatal and non-fatal pulmonary embolism in severely injured patients. Anaesth Intensive Care 2014;42:709-14.
59. Ho KM, Pavey W. Applying the cell-based coagulation model in the management of critical bleeding. Anaesth Intensive Care 2017;45:166-76.
60. Ho KM, Duff OC. Predictors of an increased in vitro thrombotic and bleeding tendency in critically ill trauma and non-trauma patients. Anaesth Intensive Care 2015;43:317-22.
61. Ho KM, Tan JA. Can the presence of significant coagulopathy be useful to exclude symptomatic acute pulmonary embolism? Anaesth Intensive Care 2013;41:322-7.
62. Allen CJ, Murray CR, Meizoso JP, et al. Surveillance and early management of Deep Vein Thrombosis decreases rate of pulmonary embolism in High-Risk Trauma Patients. J Am Coll Surg 2016;222:65-72.
63. Sud S, Mittmann N, Cook DJ, et al. Screening and prevention of venous thromboembolism in critically ill patients: a decision analysis and economic evaluation. Am J Respir Crit Care Med 2011;184:1289-98.
64. Spangler EL, Dillavou ED, Smith KJ. Cost-effectiveness of guidelines for insertion of inferior vena cava filters in high-risk trauma patients. J Vasc Surg 2010;52:1537-45.