High Bleeding RiskPhase 3CIREA1NCT00740844
Efficacy of Intermittent Pneumatic Compression (IPC) on Venous Thromboembolism Incidence in Intensive Care Unit (ICU) Patients With High Bleeding Risk
A Phase 3 study testing Intermittent pneumatic compression of the lower limbs in people with High Bleeding Risk and Hemorrhage, run by University Hospital, Brest at 10 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Bleeding Risk, Hemorrhage
- What is being tested?
- Intermittent pneumatic compression of the lower limbs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 10 sitesFrance
- Study dates
- Nov 2007to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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.
Who cannot join
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Medical intensive care unit
Angoulême
HIA Clermont-Tonnerre
Brest, 29 000
Medical Intensive Care Unit
Brest
Medical Intensive Care Unit
Lille
Intensive Care Unit
Limoges
Medical Intensive Care Unit
Nantes
Medical intensive care unit
Orléans
Medical Intensive Care Unit
Paris
Medical intensive care unit
Poitiers
Medical intensive care unit
Tours
About this 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
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.
Read the 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:
- Non fatal symptomatic venous thromboembolic event (objectively confirmed) between day 1 and day 6,
- 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.
- Conditions
- High Bleeding Risk, Hemorrhage
- Being tested
- Intermittent pneumatic compression of the lower limbs
- Keywords
- Intermittent pneumatic compression, Hospitalization, Intensive care unit, High bleeding risk, Venous thromboembolism prophylaxis
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent pneumatic compression of the lower limbsDevice
Intermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Intermittent pneumatic compression of the lower limbs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 days (+/- 2 days)
Secondary outcomes (1)
Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality at 1 month and 3 months.
Measured: 6 days to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High Bleeding RiskStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Collaborators
- Tyco Healthcare Group
- Responsible party
- Sponsor
- Investigators
- Karine LACUT, MD, Study director, CHU Brest France, Univ Brest, EA 3878
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00740844
- Sponsor's protocol ID
- CIREA 1
- Acronym
- CIREA1
- Status last verified
- Feb 2012
- First submitted
- 22 Aug 2008
- Last updated
- 3 Dec 2025
- Results posted
- No
Publications
Vignon P, Dequin PF, Renault A, Mathonnet A, Paleiron N, Imbert A, Chatellier D, Gissot V, Lheritier G, Aboyans V, Prat G, Garot D, Boulain T, Diehl JL, Bressollette L, Delluc A, Lacut K; Clinical Research in Intensive Care and Sepsis Group (CRICS Group). Intermittent pneumatic compression to prevent venous thromboembolism in patients with high risk of bleeding hospitalized in intensive care units: the CIREA1 randomized trial. Intensive Care Med. 2013 May;39(5):872-80. doi: 10.1007/s00134-013-2814-2. Epub 2013 Jan 31.
PubMed 23370827
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00740844
- Acronym / sponsor ID
- CIREA1 / CIREA 1
- Conditions
- High Bleeding Risk, Hemorrhage
- Keywords
- Intermittent pneumatic compression, Hospitalization, Intensive care unit, High bleeding risk, Venous thromboembolism prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Tyco Healthcare Group
- Study start
- Nov 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
The primary endpoint is a combined criterion (blindly evaluated) between day 1 and day 6:
- Non fatal symptomatic venous thromboembolic event (objectively confirmed) between day 1 and day 6,
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –No intermittent pneumatic compression of the lower limbs during patient hospitalisation in réanimation unit |
| 2 | Experimental | Device: Intermittent pneumatic compression of the lower limbsIntermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 Years,
- Admission in intensive medical care unit
- High risk for hemorrhage
- Written informed consent given by the patient or relative.
- symptomatic bleeding or organic lesions likely to bleed,
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent pneumatic compression of the lower limbsIntermittent pneumatic compression of the lower limbs during hospitalisation in reanimation unit | Device | 2 |
Primary outcome
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 23370827Vignon P, Dequin PF, Renault A, Mathonnet A, Paleiron N, Imbert A, Chatellier D, Gissot V, Lheritier G, Aboyans V, Prat G, Garot D, Boulain T, Diehl JL, Bressollette L, Delluc A, Lacut K; Clinical Research in Intensive Care and Sepsis Group (CRICS Group). Intermittent pneumatic compression to prevent venous thromboembolism in patients with high risk of bleeding hospitalized in intensive care units: the CIREA1 randomized trial. Intensive Care Med. 2013 May;39(5):872-80. doi: 10.1007/s00134-013-2814-2. Epub 2013 Jan 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karine LACUT, MD study director
CHU Brest France, Univ Brest, EA 3878
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intermittent pneumatic compression of the lower limbs in people with High Bleeding Risk and Hemorrhage, run by University Hospital, Brest at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00740844, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.