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Intermittent pneumatic compression to prevent venous thromboembolism in patients with high risk of bleeding hospitalized in intensive care units: the CIREA1 randomized trial

Philippe Vignon| Pierre-François Dequin| Anne Renault| Armelle Mathonnet| Nicolas Paleiron| Audrey Imbert| Delphine Chatellier| Valérie Gissot| Gwenaelle Lhéritier| Victor Aboyans| Gwenael Prat| Denis Garot| Thierry Boulain| Jean-Luc Diehl| Luc Bressollette| Aurélien Delluc| Karine Lacut
Original
Volume 39, Issue 5 / May , 2013

Pages 872 - 880

Abstract

Purpose

Venous thromboembolism (VTE) is a frequent and serious problem in intensive care units (ICU). Anticoagulant treatments have demonstrated their efficacy in preventing VTE. However, when the bleeding risk is high, they are contraindicated, and mechanical devices are recommended. To date, mechanical prophylaxis has not been rigorously evaluated in any trials in ICU patients.

Methods

In this multicenter, open-label, randomized trial with blinded evaluation of endpoints, we randomly assigned 407 patients with a high risk of bleeding to receive intermittent pneumatic compression (IPC) associated with graduated compression stockings (GCS) or GCS alone for 6 days during their ICU stay. The primary endpoint was the occurrence of a VTE between days 1 and 6, including nonfatal symptomatic documented VTE, or death due to a pulmonary embolism, or asymptomatic deep vein thrombosis detected by ultrasonography systematically performed on day 6.

Results

The primary outcome was assessed in 363 patients (89.2 %). By day 6, the incidence of the primary outcome was 5.6 % (10 of 179 patients) in the IPC + GCS group and 9.2 % (17 of 184 patients) in the GCS group (relative risk 0.60; 95 % confidence interval 0.28–1.28; p = 0.19). Tolerance of IPC was poor in only 12 patients (6.0 %). No intergroup difference in mortality rate was observed.

Conclusions

With the limitation of a low statistical power, our results do not support the superiority of the combination of IPC + GCS compared to GCS alone to prevent VTE in ICU patients at high risk of bleeding.

Keywords

References

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