Intermittent pneumatic compression to prevent venous thromboembolism in patients with high risk of bleeding hospitalized in intensive care units: the CIREA1 randomized trial.
OBJECTIVE
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.
Réanimation Polyvalente, CHU Dupuytren, Limoges, France.
Philippe
P
Vignon
Pierre-François
PF
Dequin
Anne
A
Renault
Armelle
A
Mathonnet
Nicolas
N
Paleiron
Audrey
A
Imbert
Delphine
D
Chatellier
Valérie
V
Gissot
Gwenaelle
G
Lhéritier
Victor
V
Aboyans
Gwenael
G
Prat
Denis
D
Garot
Thierry
T
Boulain
Jean-Luc
JL
Diehl
Luc
L
Bressollette
Aurélien
A
Delluc
Karine
K
Lacut
D005260:Female; D006470:Hemorrhage / Q000150:complications; D006801:Humans; D007362:Intensive Care Units; D048228:Intermittent Pneumatic Compression Devices; D008297:Male; D008875:Middle Aged; D012307:Risk Factors; D053828:Stockings, Compression; D016896:Treatment Outcome; D014463:Ultrasonography; D054556:Venous Thromboembolism / Q000000981:diagnostic imaging / Q000517:prevention & control*