NCT00740987

Brief Summary

This multicentre open-label randomized parallel-group trial aims to compare the association of intermittent pneumatic compression of the lower limbs + elastic stockings + anticoagulant prophylaxis to anticoagulant prophylaxis alone on the incidence of venous thromboembolism systematically evaluated at day 6, in patients hospitalized in intensive care units and without high bleeding risk.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
621

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2007

Longer than P75 for phase_3

Geographic Reach
2 countries

15 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
11 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
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

February 11, 2015

Status Verified

December 1, 2014

Enrollment Period

7.3 years

First QC Date

August 22, 2008

Last Update Submit

February 10, 2015

Conditions

No High Risk of Hemorrhage

Keywords

Mechanical deviceIntermittent pneumatic compressionVenous thromboembolism prophylaxisIntensive care unitHospitalizationIntensiveCareUnit

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.

    6 +/- 2 days

Secondary Outcomes (1)

  • Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality evaluated 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 hospitalisation in reanimation 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

No 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
  • No high risk for hemorrhage in CIREA 2
  • 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,
  • 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.
  • High risk for hemorrhage
  • Patient who needs a curative anticoagulant treatment (DVT, PE, PE suspicion, atrial fibrillation, myocardial infarction, acute coronary syndrome…).
  • Patients with anticoagulant prophylaxis contra-indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

CHU d'Angers

Angers, 49000, France

Location

CH d'Angoulême

Angoulême, 16000, France

Location

HIA Clermont-Tonnerre

Brest, 29 200, France

Location

Medical Intensive Care Unit

Brest, France

Location

CH de Corbeil Essonne

Corbeil Essonne, 91100, France

Location

CHU de Dijon

Dijon, 21000, France

Location

Medical Intensive Care Unit

Lille, France

Location

CH Montauban

Montauban, 82013, France

Location

CH de Morlaix

Morlaix, 29672, France

Location

Medical Intensive Care Unit

Paris, France

Location

CHU de Poitiers

Poitiers, 86000, France

Location

CH de Quimper

Quimper, 29000, France

Location

CH de St Malo

St-Malo, 35403, France

Location

CHU de Tours

Tours, 37000, France

Location

CH Monaco

Monaco, Monaco

Location

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

October 1, 2007

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

February 11, 2015

Record last verified: 2014-12

Locations

FR(14)MO(1)