Thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients: study protocol for a randomized controlled trial

Yaseen M Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E A Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I Abdukahil, Lara Y Afesh, Maamoun Dbsawy, Musharaf Sadat, Yaseen M Arabi, Sami Alsolamy, Abdulaziz Al-Dawood, Awad Al-Omari, Fahad Al-Hameed, Karen E A Burns, Mohammed Almaani, Hani Lababidi, Ali Al Bshabshe, Sangeeta Mehta, Abdulsalam M Al-Aithan, Yasser Mandourah, Ghaleb Almekhlafi, Simon Finfer, Sheryl Ann I Abdukahil, Lara Y Afesh, Maamoun Dbsawy, Musharaf Sadat

Abstract

Background: Venous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE.

Methods/design: The PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %.

Discussion: The first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018.

Trial registration: Clinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).

Keywords: Adjunct mechanical and pharmacologic DVT prophylaxis; Critically ill patients; Deep vein thrombosis; Intermittent pneumatic compression; Pulmonary embolism.

Figures

Fig. 1
Fig. 1
Schedule of enrollment, intervention and assessment for the thromboprophylaxis using combined intermittent pneumatic compression and pharmacologic prophylaxis versus pharmacologic prophylaxis alone in critically ill patients (PREVENT) trial

References

    1. Cook DJ, Crowther MA. Thromboprophylaxis in the intensive care unit: focus on medical-surgical patients. Crit Care Med. 2010;38:S76–82. doi: 10.1097/CCM.0b013e3181c9e344.
    1. Kahn SR, Lim W, Dunn AS, et al. Prevention of VTE in nonsurgical patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012;141:e195S–226. doi: 10.1378/chest.11-2296.
    1. Ginzburg E, Cohn SM, Lopez J, Jackowski J, Brown M, Hameed SM. Randomized clinical trial of intermittent pneumatic compression and low molecular weight heparin in trauma. Br J Surg. 2003;90:1338–44. doi: 10.1002/bjs.4309.
    1. 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. doi: 10.1007/s00268-004-7295-6.
    1. Limpus A, Chaboyer W, McDonald E, Thalib L. Mechanical thromboprophylaxis in critically ill patients: a systematic review and meta-analysis. Am J Crit Care. 2006;15:402–10. quiz/discussion, 11–2.
    1. Qaseem A, Chou R, Humphrey LL, Starkey M, Shekelle P. Venous thromboembolism prophylaxis in hospitalized patients: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2011;155:625–32. doi: 10.7326/0003-4819-155-9-201111010-00011.
    1. Arabi YM, Khedr M, Dara SI, et al. Use of intermittent pneumatic compression and not graduated compression stockings is associated with lower incident VTE in critically ill patients: a multiple propensity scores adjusted analysis. Chest. 2013;144:152–9. doi: 10.1378/chest.12-2028.
    1. Dennis M, Sandercock P, Reid J, Graham C, Forbes J, Murray G. Effectiveness of intermittent pneumatic compression in reduction of risk of deep vein thrombosis in patients who have had a stroke (CLOTS 3): a multicentre randomised controlled trial. Lancet. 2013;382:516–24. doi: 10.1016/S0140-6736(13)62282-5.
    1. Dennis M, Sandercock PA, Reid J, et al. Effectiveness of thigh-length graduated compression stockings to reduce the risk of deep vein thrombosis after stroke (CLOTS trial 1): a multicentre, randomised controlled trial. Lancet. 2009;373:1958–65. doi: 10.1016/S0140-6736(09)60941-7.
    1. CLOTS (Clots in Legs Or sTockings after Stroke) Trial Collaboration. Thigh-length versus below-knee stockings for deep venous thrombosis prophylaxis after stroke: a randomized trial. Ann Intern Med 2010;153:553–62.
    1. Morris RJ, Giddings JC, Ralis HM, et al. The influence of inflation rate on the hematologic and hemodynamic effects of intermittent pneumatic calf compression for deep vein thrombosis prophylaxis. J Vasc Surg. 2006;44:1039–45. doi: 10.1016/j.jvs.2006.06.016.
    1. Unger RJ, Feiner JR. Hemodynamic effects of intermittent pneumatic compression of the legs. Anesthesiology. 1987;67:266–8. doi: 10.1097/00000542-198708000-00023.
    1. Bickel A, Shturman A, Grevtzev I, Roguin N, Eitan A. The physiological impact of intermittent sequential pneumatic compression (ISPC) leg sleeves on cardiac activity. Am J Surg. 2011;202:16–22. doi: 10.1016/j.amjsurg.2010.04.020.
    1. Cook D, Laporta D, Skrobik Y, et al. Prevention of venous thromboembolism in critically ill surgery patients: a cross-sectional study. J Crit Care. 2001;16:161–6. doi: 10.1053/jcrc.2001.30665.
    1. Lacherade JC, Cook D, Heyland D, Chrusch C, Brochard L, Brun-Buisson C. Prevention of venous thromboembolism in critically ill medical patients: a Franco-Canadian cross-sectional study. J Crit Care. 2003;18:228–37. doi: 10.1016/j.jcrc.2003.10.006.
    1. Mullges W, Steinke E, Moldenhauer G, Berens N. Customary use of compression stockings for prevention of thrombosis in medical intensive care units in Germany. Dtsch Med Wochenschr. 2001;126:867–71. doi: 10.1055/s-2001-16312.
    1. Limpus A, Chaboyer W. The use of graduated compression stockings in Australian intensive care units: a national audit. Aust Crit Care. 2003;16(2)53–8.
    1. Cook D, Meade M, Guyatt G, et al. Dalteparin versus unfractionated heparin in critically ill patients. N Engl J Med. 2011;364:1305–14. doi: 10.1056/NEJMoa1014475.
    1. Uniform requirements for manuscripts submitted to biomedical journals. International Committee of Medical Journal Editors. N Engl J Med 1997;336:309–15
    1. Righini M. Is it worth diagnosing and treating distal deep vein thrombosis? No. J Thromb Haemost. 2007;5(Suppl 1):55–9. doi: 10.1111/j.1538-7836.2007.02468.x.

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