Status:
COMPLETED
Efficacy of Intermittent Pneumatic Compression (IPC) on Venous Thromboembolism Incidence in Intensive Care Unit (ICU) Patients With High Bleeding Risk
Lead Sponsor:
University Hospital, Brest
Collaborating Sponsors:
Tyco Healthcare Group
Conditions:
High Bleeding Risk
Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 a...
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
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00740844
Start Date
November 1 2007
End Date
December 1 2011
Last Update
December 3 2025
Active Locations (10)
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1
Medical intensive care unit
Angoulême, France
2
HIA Clermont-Tonnerre
Brest, France, 29 000
3
Medical Intensive Care Unit
Brest, France
4
Medical Intensive Care Unit
Lille, France