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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

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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.

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Acknowledgments

This study was supported by a grant from the French Ministry of Health (PHRCN 2005 no. 08-13). COVIDIEN supplied the GCS (T.E.D.™ anti-embolism stockings) and the IPC (SCD EXPRESS™ compression systems with tubing sets and sleeves). The sponsor had no role in the study. We thank the research coordinator I. Pichon, the members of the CIC-P 0502 and the CIC-P 0801, the study nurses of the Clinical Research in Intensive Care and Sepsis Group (CRICS group), the Direction de la Recherche Clinique et Innovation (DRCI) of Brest University Hospital for their invaluable work, as well as Z. Alavi for her pertinent advice.

Conflicts of interest

The authors state that they have no conflict of interest.

Author information

Authors and Affiliations

  1. Réanimation Polyvalente, CHU Dupuytren, 87042, Limoges, France

    Philippe Vignon & Gwenaelle Lhéritier

  2. INSERM, CIC-P 0801, CHU Dupuytren, 87042, Limoges, France

    Philippe Vignon & Gwenaelle Lhéritier

  3. Université de Limoges, 87000, Limoges, France

    Philippe Vignon & Gwenaelle Lhéritier

  4. Université François Rabelais et service de Réanimation Médicale, CHU de Tours–Hôpital Bretonneau, Tours, France

    Pierre-François Dequin & Denis Garot

  5. Service de Réanimation Médicale, CHU de la Cavale Blanche, Brest, France

    Anne Renault & Gwenael Prat

  6. Réanimation, CHR–Hôpital de la Source, Orléans, France

    Armelle Mathonnet & Thierry Boulain

  7. Service des maladies respiratoires, HIA Clermont-Tonnerre, Brest, France

    Nicolas Paleiron

  8. Réanimation Médicale, HEGP AP-HP, Paris, France

    Audrey Imbert & Jean-Luc Diehl

  9. Service de Réanimation Médicale, CHU de Poitiers, Poitiers, France

    Delphine Chatellier

  10. Service de Réanimation Polyvalente, CH D’Angoulême, Saint-Michel, France

    Valérie Gissot

  11. Service de Cardiologie, CHU de Limoges, Limoges, France

    Victor Aboyans

  12. INSERM U765, Université Paris Descartes, Sorbonne Paris Cité, France

    Jean-Luc Diehl

  13. EA3878, Université de Bretagne Occidentale, 29200, Brest, France

    Luc Bressollette, Aurélien Delluc & Karine Lacut

  14. Unité de Médecine Vasculaire, CHU Brest, 29609, Brest, France

    Luc Bressollette

  15. Département de Médecine Interne et Pneumologie, CHU Brest, 29609, Brest, France

    Aurélien Delluc

  16. INSERM, CIC 0502, Brest, France

    Karine Lacut

  17. CIC 0502, Hôpital de la Cavale Blanche, Bd Tanguy Prigent, F-29609, Brest Cedex, France

    Karine Lacut

Authors
  1. Philippe Vignon
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  2. Pierre-François Dequin
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  3. Anne Renault
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  4. Armelle Mathonnet
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  5. Nicolas Paleiron
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  6. Audrey Imbert
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  7. Delphine Chatellier
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  8. Valérie Gissot
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  9. Gwenaelle Lhéritier
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  10. Victor Aboyans
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  11. Gwenael Prat
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  12. Denis Garot
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  13. Thierry Boulain
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  14. Jean-Luc Diehl
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  15. Luc Bressollette
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  16. Aurélien Delluc
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  17. Karine Lacut
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Consortia

The Clinical Research in Intensive Care and Sepsis Group (CRICS Group)

Corresponding author

Correspondence to Karine Lacut.

Appendix

Appendix

CIREA1 collaborators:

Steering Committee: Pr Jean-Luc Diehl, Pr Philippe Vignon, Dr Anne Renault, Pr Karine Lacut

Adjudication Committee: Pr L. Bressollette (expert ultrasonographer), Pr Erwan L’Her

Data manager and Biostatistician: Elise Poulhazan, Emmanuel Nowak

Investigators:

Service de Réanimation Polyvalente, CH d’Angoulême, Saint-Michel: Dr Thierry Baudin-Jacquemin, Dr Sylvie Nicole Calvat, Dr Arnaud Desachy, Dr Florence Hospital

Service de Réanimation Médicale, CHU de la Cavale Blanche, Brest: Dr Montaine Lefèvre, Dr Jean-Marie Tonnelier, Dr Alexandre Tonnelier

Fédération d’Anesthésie, Réanimation Urgences, HIA Clermont-Tonnerre, Brest : Dr Christophe Giarcardi, Dr Bruno Ralec, Dr Mehdi Ould-Ahmed, Dr Didier Fourel, Dr Ba Vinh N Guyen, Dr Diane Commandeur.

Réanimation Polyvalente, CHU de Limoges, Limoges: Dr Jean-Bernard Amiel, Dr Marc Clavel, Dr Anthony Dugard, Dr Caroline Etchecopar-Chevreuil, Dr Bruno François, Dr Nicolas Pichon, Dr Jean-Claude Voultoury.

Service de Réanimation Médicale, CHU Hôtel Dieu, Nantes: Dr Olivier Zambon

Réanimation, CHR—Hôpital de la Source, Orléans: Dr Isabelle Runge, Dr Christian Fleury, Dr Marie Skarzynski, Dr Dalila Benzekri-Lefevre, Dr Anne Bretagnol, Dr Nicolas Bercault

Réanimation Médicale, HEGP, AP-HP Paris: Dr Emmanuel Guerot, Dr Ana Novara, Dr Christophe Faisy, Dr Iris Pelieu, Pr Nicolas Lerolle

Service de Réanimation Médicale, CHU de Poitiers, Poitiers: Pr Olivier Pourrat, Dr Julien Voultoury, Dr Michel Pinsard, Dr Anne Veinstein, Dr Jean-Pierre Frat, Dr Julie Badin, Pr René Robert

Service de Réanimation Médicale, CHU de Tours—Hôpital Bretonneau, Tours: Dr Annick Legras, Dr Emmanuelle Mercier, Dr Laure Batias-Moreau, Dr Stéphane Ehrmann, Dr Stéphanie Benardeau, Dr Maud Jonas, Dr Antoine Guillon, Dr Jennifer Buret, Dr Elodie Masseret

Vascular Ultrasonography Collaborators:

Imagerie Médicale, CH d’Angoulême, Saint-Michel: Dr Florence Hospital, Dr Danièle Colin, Dr Thierry Landois

Radiologie, HIA, Clermont-Tonnerre, Brest : Dr Jean Rousset, Dr Marc Garetier, Dr Diouf, Dr Sandra Chinellato, Dr Valentin Tissot

Unité Vasculaire du service de Chirurgie Thoracique et Cardiovasculaire, CHU de Limoges, Limoges: Pr Philippe Lacroix, Dr Tiphaine Bonnafy

Service d’explorations vasculaires, CHU Hôtel Dieu, Nantes: Dr Jérôme Connault

Angiologie, CHR—Hôpital de la Source, Orléans: Dr Carole Bazzi

Médecine vasculaire et hypertension artérielle, HEGP, AP-HP Paris: Pr Joseph Emmerich, Dr Emmanuel Messas

Radiologie, Echographie-Doppler, CHU de Poitiers, Poitiers: Dr Elisabeth Escure, Dr Cécile Thollot, Dr Jérôme Roumy

Pôle imagerie médicale, CHU de Tours—Hôpital Bretonneau, Tours: Dr Nicole Ferreira, Pr Frédéric Patat

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Vignon, P., Dequin, PF., Renault, A. et al. Intermittent pneumatic compression to prevent venous thromboembolism in patients with high risk of bleeding hospitalized in intensive care units: the CIREA1 randomized trial. Intensive Care Med 39, 872–880 (2013). https://doi.org/10.1007/s00134-013-2814-2

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