NCT00740844

Brief Summary

This multicentre open-label randomized parallel-group trial aims to evaluate the association intermittent pneumatic compression + elastick stockings versus elasting stockings alone on symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day 6 (+/-2days), in patients hospitalized in intensive care units and with high bleeding risk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 3, 2025

Status Verified

February 1, 2012

Enrollment Period

3.2 years

First QC Date

August 22, 2008

Last Update Submit

November 26, 2025

Conditions

HemorrhageHigh Bleeding Risk

Keywords

Intermittent pneumatic compressionHospitalizationIntensive care unitHigh bleeding riskVenous thromboembolism prophylaxis

Outcome Measures

Primary Outcomes (1)

  • Combined criterion evaluated at day 6 ± 2 days after randomization:symptomatic venous thromboembolic event, non fatal, objectively confirmed,Death related to PE,Asymptomatic DVT of the lower limbs detected by CUS on day 6 ± 2 days.

    6 days (+/- 2 days)

Secondary Outcomes (1)

  • Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality at 1 month and 3 months.

    6 days to 3 months

Study Arms (2)

1

NO INTERVENTION

No intermittent pneumatic compression of the lower limbs during patient hospitalisation in réanimation unit

2

EXPERIMENTAL

Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit

Device: Intermittent pneumatic compression of the lower limbs

Interventions

Intermittent pneumatic compression of the lower limbsDEVICE

Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18 Years,
  • Admission in intensive medical care unit
  • High risk for hemorrhage
  • Written informed consent given by the patient or relative.
  • High risk for hemorrhage is defined by:
  • symptomatic bleeding or organic lesions likely to bleed,
  • hemophilic diseases,
  • haemostatic abnormalities: platelet count \< 50 000/mm 3, APTT \> 2 N, prothrombin time \< 40%,
  • recent intra-cerebral hemorrhage,
  • severe anemia (Hemoglobin \< 7 g/dl) due to a bleeding or unexplained.

You may not qualify if:

  • Age \< 18 years,
  • Patient refusal,
  • No high risk for hemorrhage
  • Admission in intensive care unit ≥ 36 hours
  • Admission in intensive care unit likely for \< 72 hours
  • A "do not resuscitate" order
  • IPC contra-indication: Recent DVT (\< 3 month), severe lower limbs arteriopathy (III and IV), any arterial graft of the legs, a wound in the lower limb related either to a vascular disease (ulcer) or a trauma.
  • Patient with mechanical prosthetic heart valve.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Medical intensive care unit

Angoulême, France

Location

HIA Clermont-Tonnerre

Brest, 29 000, France

Location

Medical Intensive Care Unit

Brest, France

Location

Medical Intensive Care Unit

Lille, France

Location

Intensive Care Unit

Limoges, France

Location

Medical Intensive Care Unit

Nantes, France

Location

Medical intensive care unit

Orléans, France

Location

Medical Intensive Care Unit

Paris, France

Location

Medical intensive care unit

Poitiers, France

Location

Medical intensive care unit

Tours, France

Location

Related Publications (1)

  • Vignon P, Dequin PF, Renault A, Mathonnet A, Paleiron N, Imbert A, Chatellier D, Gissot V, Lheritier G, Aboyans V, Prat G, Garot D, Boulain T, Diehl JL, Bressollette L, Delluc A, Lacut K; Clinical Research in Intensive Care and Sepsis Group (CRICS Group). 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. 2013 May;39(5):872-80. doi: 10.1007/s00134-013-2814-2. Epub 2013 Jan 31.

    PMID: 23370827RESULT

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Karine LACUT, MD

    CHU Brest France, Univ Brest, EA 3878

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2008

First Posted

August 25, 2008

Study Start

November 1, 2007

Primary Completion

January 1, 2011

Study Completion

December 1, 2011

Last Updated

December 3, 2025

Record last verified: 2012-02

Locations

FR(10)