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

Sponsors and Collaborators:	University Hospital, Brest Tyco Healthcare
Information provided by:	University Hospital, Brest
ClinicalTrials.gov Identifier:	NCT00740844

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 III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

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 ]

Estimated Enrollment:	392
Study Start Date:	March 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention No intermittent pneumatic compression of the lower limbs during patient hospitalisation in réanimation unit
2: Experimental 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

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00740844

Contacts

Contact: Karine LACUT, MD

+33298347336

karine.lacut@chu-brest.fr

Locations

France
Medical Intensive Care Unit	Recruiting
Brest, France
Contact: Anne RENAULT, MD anne.renault@chu-brest.fr
Intensive Care Unit	Recruiting
Limoges, France
Contact: Philippe VIGNON, PhD
Medical Intensive Care Unit	Recruiting
Paris, France
Contact: Jean-Luc DIEHL, PhD
Medical Intensive Care Unit	Not yet recruiting
Nantes, France
Contact: Olivier ZAMBON, MD
Medical Intensive Care Unit	Recruiting
Lille, France
Contact: Fabienne SAULNIER, PhD

Sponsors and Collaborators

University Hospital, Brest

Tyco Healthcare

Investigators

Study Director:

Karine LACUT, MD

CHU Brest France, Univ Brest, EA 3878

More Information

Responsible Party:	DMIP - CHU de Brest ( Doctor Karine LACUT )
Study ID Numbers:	CIREA 1
Study First Received:	August 22, 2008
Last Updated:	August 22, 2008
ClinicalTrials.gov Identifier:	NCT00740844
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Brest:

Intermittent pneumatic compression
Hospitalization
Intensive care unit
High bleeding risk
Venous thromboembolism prophylaxis

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases
Hemorrhage

Venous Thromboembolism
Thrombosis
Thromboembolism

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009