No High Risk of HemorrhagePhase 3CIREA2NCT00740987
Efficacy of the Association Mechanical Prophylaxis + Anticoagulant Prophylaxis on Venous Thromboembolism Incidence in Intensive Care Unit (ICU)
A Phase 3 study testing Intermittent pneumatic compression of the lower limbs in people with No High Risk of Hemorrhage, run by University Hospital, Brest at 15 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- No High Risk of 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
- 621 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Oct 2007to Jan 2015
- 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
- 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,
Show all 10Show fewer
- 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,
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France14 sites
CHU d'Angers
Angers, 49000
CH d'Angoulême
Angoulême, 16000
HIA Clermont-Tonnerre
Brest, 29 200
Medical Intensive Care Unit
Brest
CH de Corbeil Essonne
Corbeil Essonne, 91100
CHU de Dijon
Dijon, 21000
Medical Intensive Care Unit
Lille
CH Montauban
Montauban, 82013
CH de Morlaix
Morlaix, 29672
Medical Intensive Care Unit
Paris
CHU de Poitiers
Poitiers, 86000
CH de Quimper
Quimper, 29000
CH de St Malo
St-Malo, 35403
CHU de Tours
Tours, 37000
About this study
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
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.
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 %. 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:
- 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
- Being tested
- Intermittent pneumatic compression of the lower limbs
- Keywords
- Mechanical device, Intermittent pneumatic compression, Venous thromboembolism prophylaxis, Intensive care unit, Hospitalization, Intensive, Care, Unit
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
No 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 hospitalisation in reanimation 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.
Measured: 6 +/- 2 days
Secondary outcomes (1)
Symptomatic thromboembolic events occurred between day 6 and day 90, and total mortality evaluated 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 startOct 2007
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No High Risk of HemorrhageStudies 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
- 621 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
- NCT00740987
- Sponsor's protocol ID
- CIREA2
- Acronym
- CIREA2
- Status last verified
- Dec 2014
- First submitted
- 22 Aug 2008
- Last updated
- 11 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00740987
- Acronym / sponsor ID
- CIREA2 / CIREA2
- Conditions
- No High Risk of Hemorrhage
- Keywords
- Mechanical device, Intermittent pneumatic compression, Venous thromboembolism prophylaxis, Intensive care unit, Hospitalization, Intensive, Care, Unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 621 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Collaborators
- Tyco Healthcare Group
- Study start
- Oct 2007
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (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 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:
- 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.
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 hospitalisation in reanimation 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
- No high risk for hemorrhage in CIREA 2
- Written informed consent given by the patient or relative.
- symptomatic bleeding or organic lesions likely to bleed,
Key exclusion criteria (9 listed)
- 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
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 limbsNo Intermittent 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.
Time frame: 6 +/- 2 days
1 secondary outcome
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
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 11 Feb 2015.
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
15 sites in 2 countries: 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 No High Risk of Hemorrhage, run by University Hospital, Brest at 15 sites in 2 countries.
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 9 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 11 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Monaco. 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. (time frame: 6 +/- 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Feb 2015.