Efficacy of the Association Mechanical Prophylaxis + Anticoagulant Prophylaxis on Venous Thromboembolism Incidence in Intensive Care Unit (ICU) (CIREA2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University Hospital, Brest
Sponsor:
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740987
First received: August 22, 2008
Last updated: January 4, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
No High Risk of Hemorrhage
Device: Intermittent pneumatic compression of the lower limbs
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Intermittent Pneumatic Compression Associated With Elastic Stockings and Anticoagulant Prophylaxis Versus Anticoagulant Prophylaxis Alone on Venous Thromboembolism Incidence in ICU Patients Without High Risk of Bleeding

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

Primary Outcome Measures:
  • 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. [ Time Frame: 6 +/- 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality evaluated at 1 month and 3 months. [ Time Frame: 6 days to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 1580
Study Start Date: March 2007
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
Experimental: 2
Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
Device: Intermittent pneumatic compression of the lower limbs
No Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740987

Contacts
Contact: Karine LACUT, MD +33298347336 karine.lacut@chu-brest.fr

Locations
France
CHU d'Angers Recruiting
Angers, France, 49000
Contact: Nicolas LEROLLE, Dr         
Principal Investigator: Nicolas LEROLLE, Dr         
CH d'Angoulême Recruiting
Angoulême, France, 16000
Contact: Charles LAFON, Dr         
Principal Investigator: Charles LAFON, Dr         
Medical Intensive Care Unit Recruiting
Brest, France
Contact: Anne RENAULT, MD         
HIA Clermont-Tonnerre Recruiting
Brest, France, 29 200
Contact: Nicolas Paleiron, Dr         
Principal Investigator: Nicolas Paleiron, Dr         
CH de Corbeil Essonne Recruiting
Corbeil Essonne, France, 91100
Contact: Guillaume CHEVREL, Dr         
Principal Investigator: Guillaume CHEVREL, Dr         
CHU de Dijon Recruiting
Dijon, France, 21000
Contact: Jean-Pierre Quenot, Dr         
Principal Investigator: Jean-Pierre Quenot, Dr         
Medical Intensive Care Unit Terminated
Lille, France
CH Montauban Recruiting
Montauban, France, 82013
Contact: Frédéric Bellec, Dr         
Principal Investigator: Frédéric Bellec, Dr         
CH de Morlaix Recruiting
Morlaix, France, 29672
Contact: Montaine Lefevre, Dr         
Principal Investigator: Montaine Lefevre, Dr         
Medical Intensive Care Unit Recruiting
Paris, France
Contact: Jean-Luc DIEHL, PhD         
CHU de Poitiers Recruiting
Poitiers, France, 86000
Contact: Delphine Chatelier         
Principal Investigator: Delphine Chatelier, Dr         
CH de St Malo Recruiting
Saint Malo, France, 35403
Contact: François Collet, Dr         
Principal Investigator: François Collet, Dr         
CHU de Tours Recruiting
Tours, France, 37000
Contact: Pierre-François Dequin, Pr         
Principal Investigator: Pierre-François Dequin, Pr         
Sponsors and Collaborators
University Hospital, Brest
Tyco Healthcare Group
Investigators
Study Director: Karine LACUT, MD CHU Brest France, Univ Brest, EA 3878
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT00740987     History of Changes
Other Study ID Numbers: CIREA2
Study First Received: August 22, 2008
Last Updated: January 4, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Mechanical device
Intermittent pneumatic compression
Venous thromboembolism prophylaxis
Intensive care unit
Hospitalization
Intensive
Care
Unit

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014