Efficacy of the Association Mechanical Prophylaxis + Anticoagulant Prophylaxis on Venous Thromboembolism Incidence in Intensive Care Unit (ICU)

NCT ID: NCT00740987

Last Updated: 2015-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 621 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2015-01-31

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.

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 %. Mechanical devices such as elastic stockings (ES) or intermittent pneumatic compression (IPC), devoid of bleeding risk, can be associated with heparins, with good efficacy in some specific clinical settings. The effect of combined treatment use has never been evaluated rigorously in intensive medical care units.

Objective:

To compare the association IPC+ ES + anticoagulant prophylaxis to anticoagulant prophylaxis alone in patients without high bleeding risk and hospitalized in medical intensive 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:

The primary endpoint is a combined criterion (blindly evaluated) between day 1 and day 6:

1) Non fatal symptomatic venous thromboembolic event (objectively confirmed) between day 1 and day 6, 2) death due to a pulmonary embolism between day 1 and day 6, and 3) asymptomatic DVT detected by ultrasonography systematically done at day 6.

Patients number:

Assuming a DVT frequency of 10 % in the control group (anticoagulant prophylaxis alone), we calculated that 1436 patients will be required for the study to have 80% power to detect a 40 % reduction in the relative risk with a two-sided alpha level of 5%. Because of about 20 % deaths in the first days, we decide to increase the number at 1580 subjects.

Statistical analysis:

Efficacy analysis is performed on an 'intention-to-treat' basis. The frequencies of the combined primary outcome at day 6 are compared between groups using an exact one-sided Fischer test. Adjustment for stratification variables used Cochran-Mantel-Haenszel test. Relative risk and absolute risk reduction are computed with their 95% CIs. A logistic regression model is used to take into account potential imbalance in baseline characteristics.

Conditions

No High Risk of Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

No Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

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

Group Type: EXPERIMENTAL

Intermittent pneumatic compression of the lower limbs

Intervention Type: DEVICE

No Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit

Interventions

Intermittent pneumatic compression of the lower limbs

No Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tyco Healthcare Group

INDUSTRY

Sponsor Role: collaborator

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karine LACUT, MD

Role: STUDY_DIRECTOR

CHU Brest France, Univ Brest, EA 3878

Locations

CHU d'Angers

Angers, , France

CH d'Angoulême

Angoulême, , France

HIA Clermont-Tonnerre

Brest, , France

Medical Intensive Care Unit

Brest, , France

CH de Corbeil Essonne

Corbeil Essonne, , France

CHU de Dijon

Dijon, , France

Medical Intensive Care Unit

Lille, , France

CH Montauban

Montauban, , France

CH de Morlaix

Morlaix, , France

Medical Intensive Care Unit

Paris, , France

CHU de Poitiers

Poitiers, , France

CH de Quimper

Quimper, , France

CH de St Malo

St-Malo, , France

CHU de Tours

Tours, , France

CH Monaco

Monaco, , Monaco

Countries

France; Monaco

Other Identifiers

CIREA2

Identifier Type: -

Identifier Source: org_study_id