Status:
COMPLETED
Efficacy of the Association Mechanical Prophylaxis + Anticoagulant Prophylaxis on Venous Thromboembolism Incidence in Intensive Care Unit (ICU)
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Tyco Healthcare Group
Conditions:
No High Risk of Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
Background: Venous thromboembolism is a leading cause of morbi-mortality for patients hospitalized in intensive medical care units. Nevertheless, few studies evaluating prophylactic methods exist. Dat...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
621 Patients enrolled
Trial Details
Trial ID
NCT00740987
Start Date
October 1 2007
End Date
January 1 2015
Last Update
February 11 2015
Active Locations (15)
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1
CHU d'Angers
Angers, France, 49000
2
CH d'Angoulême
Angoulême, France, 16000
3
HIA Clermont-Tonnerre
Brest, France, 29 200
4
Medical Intensive Care Unit
Brest, France