Efficacy of Intermittent Pneumatic Compression (IPC) on Venous Thromboembolism Incidence in Intensive Care Unit (ICU) Patients With High Bleeding Risk (CIREA1)

This study has been completed.
Sponsor:
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT00740844
First received: August 22, 2008
Last updated: February 13, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
High Bleeding Risk
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 (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

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 ± 2 days. [ Time Frame: 6 days (+/- 2 days) ] [ Designated as safety issue: No ]

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

Enrollment: 408
Study Start Date: November 2007
Study Completion Date: December 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No intermittent pneumatic compression of the lower limbs during patient hospitalisation in réanimation unit
Experimental: 2
Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
Device: Intermittent pneumatic compression of the lower limbs
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 %. 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:

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 (distal or proximal) detected by ultrasonography systematically done at day 6.

Patients number:

CIREA 1 : Assuming a DVT frequency of 15 % in the control group (ES alone) , we calculated that 356 patients will be required for the study to have 80% power to detect a 60% 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 392 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
  • 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.
  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: NCT00740844

Locations
France
Medical intensive care unit
Angouleme, France
Medical Intensive Care Unit
Brest, France
HIA Clermont-Tonnerre
Brest, France, 29 000
Medical Intensive Care Unit
Lille, France
Intensive Care Unit
Limoges, France
Medical Intensive Care Unit
Nantes, France
Medical intensive care unit
Orléans, France
Medical Intensive Care Unit
Paris, France
Medical intensive care unit
Poitiers, France
Medical intensive care unit
Tours, France
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: NCT00740844     History of Changes
Other Study ID Numbers: CIREA 1
Study First Received: August 22, 2008
Last Updated: February 13, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Brest:
Intermittent pneumatic compression
Hospitalization
Intensive care unit
High bleeding risk
Venous thromboembolism prophylaxis

Additional relevant MeSH terms:
Hemorrhage
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on October 02, 2014