Evaluation of Intermittent Pneumatic Compression (IPC) of the Lower Limbs Associated With Elastic Stockings (ES) Compared to ES Alone on Venous Thromboembolism Incidence in Patients With High Bleeding Risk Hospitalized in Intensive Medical Care Units
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- University Hospital, Brest
- Enrollment
- 408
- Locations
- 13
- Primary Endpoint
- 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.
Study Overview
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.
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. Data from these studies demonstrate however that unfractionated heparin and low molecular weight heparin are effective to reduce the incident rate of asymptomatic deep venous thrombosis (DVT) of the lower limbs by 50 % compared to the absence of prophylaxis. Rate of asymptomatic DVT remains about 15 %. When the bleeding risk is high, drug prophylaxis with anticoagulants is contra-indicated, and mechanical devices are recommended: elastic stockings (ES) alone or associated with intermittent pneumatic compression (IPC). However, mechanical devices have not been systematically evaluated in intensive medical care units.
Objective:
To compare the association IPC + ES to ES alone in patients with high bleeding risk and hospitalized in intensive medical care units, on symptomatic or asymptomatic venous thromboembolism incidence, evaluated systematically at day 6.
Design: Multicentre open-label randomized parallel-group trial with blinded evaluation of outcomes, and an inclusion period of 24 month. Brest CIC (Centre d'Investigations Cliniques, research center) coordinates this multicentre trial.
Outcomes:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Arms & Interventions
1
No intermittent pneumatic compression of the lower limbs during patient hospitalisation in réanimation unit
2
Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
Intervention: Intermittent pneumatic compression of the lower limbs (Device)
Outcomes
Primary Outcomes
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.
Time Frame: 6 days (+/- 2 days)
Secondary Outcomes
- Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality at 1 month and 3 months.(6 days to 3 months)