C.Surgical Procedure; CardiacIMOTECNCT02972684
Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery With Cardiopulmonary Bypass
A study testing Thrombo-elastometry POC testing in people with C.Surgical Procedure; Cardiac and Blood Transfusion, run by Nantes University Hospital at 15 sites in France.
Trial summary
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions. Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Cardiac, Blood Transfusion, Blood Coagulation Disorders
- What is being tested?
- Thrombo-elastometry POC testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,098 participants
- Where
- 15 sitesFrance
- Study dates
- 3 Jan 2017to Feb 2020
- Phase
- Interventional
- 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
- Blood Coagulation test sampling indication for intra or post-operative bleeding defined as follow:
- intra-operative post CPB bleeding; evaluation more than 10min after heparin reversal by protamin.
- Clinically significant bleeding judged on surgeon and anesthesiologist consensual point of view
- Sternal closure delay
- Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min (2ml/kg/h)
- Postoperative period , evaluation in post operative care environment after 30min stabilization period
- Chest tube bleeding exceeding 50ml in 10min or more than 1ml/kg in 30min (2ml/kg/h)
- Patient requiring surgical re-exploration for diagnosed or suspected pericardial effusion or surgical site bleeding requiring surgical hemostatic intervention
Who cannot join
- Known congenital bleeding disorder
- Redo surgery for patient previously included in the study
- Implantation of Cardiac support device, Extra Corporeal Membrane Oxygenation (ECMO) Extra Corporeal Life support (ECLS), uni or bi-ventricular artificial hearts.
- Indication for post-CPB ECMO or ECLS
- blood transfusion refusal
- pregnant women
- patients under 18 years old
- Adult patient under guardianship, trusteeship or safeguard justice
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
France15 sites
Angers University Hospital
Angers
Bordeaux University hospital
Bordeaux
Caen University Hospital
Caen
Clermont-Ferrand University Hospital
Clermont-Ferrand
Dijon University Hospital
Dijon
Lille University hospital
Lille
Marseille AP-HM La Timone
Marseille
Nancy University Hospital
Nancy
APHP, La Pitié Salpétrière
Paris
HEGP, Hôpital Européen Georges Pompidou
Paris
Rouen University Hospital
Rouen
Saint-Etienne University Hospital
Saint-Etienne
Strasbourg Universtiy Hospital
Strasbourg
Toulouse University Hospital
Toulouse
Tours University Hospital
Tours
About this study
Official title: Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions.
Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. All are expensive treatment and decision making is guided by patient clinical status and biological tests of the haemostatic function.
Read more
A key point is the time frame of the clinical process. Therapeutic choices have to be done as fast as possible to minimize bleeding consequences on patient haemodynamic and physiological status. Conventional coagulation test results availability time usually exceed 45' after blood drawing. In such situation, the results may not reflect precisely the coagulation system current state. This downside is often counterbalanced by clinicians empirical choices preceding lab test results knowledge that may conduct to inappropriate treatment, blood product overuse and undue expense.
Viscoelastic point of care test may compensate for the limitations of conventional coagulation tests. In perioperative haemorrhage, faster and more precise information about haemostatic function may help for more accurate therapeutic choices.
The IMOTEC study aims to compare haemorrhage management following cardiac surgery using conventional blood coagulation tests or thrombo-elastogaphic point of care test.
Primary endpoint is a cost utility analysis of the technology and secondary endpoints include blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative infection (any cause), organ failure, in hospital length of stay and death.
Read the detailed description
The research is a real life, prospective, single blinded stepped wedge randomized study.
Inclusion after informed consent of adult patient having cardio-vascular surgical procedure using cardiopulmonary bypass and meeting inclusion criterion "bleeding".
After meeting inclusion criterion patients are managed either using conventional blood coagulation tests or using thrombo-elastometry POC test and predefined therapeutic interventions described in a specific algorithm.
Other elements of patient clinical management follow usual center standard care .
Follow up of EQ-5D and clinical evaluations are performed at one , 6 and 12 months after inclusion.
- Conditions
- C.Surgical Procedure; Cardiac, Blood Transfusion, Blood Coagulation Disorders, Bypass, Cardiopulmonary, Hemostatic
- Being tested
- Thrombo-elastometry POC testing
- Keywords
- Cardiopulmonary Bypass, Hemorrhage, blood transfusion, Point-of-care test, health economics
- Medical subject headings
- Blood Coagulation Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thrombo-elastometry POC testingDevice
Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage
| Study group | Role | What they receive |
|---|---|---|
| Conventional coagulation management | No intervention | management of perioperative haemorrhage following cardiac surgery using conventional blood coagulation tests. |
| Thrombo-elastometry POC testing | Experimental | management of perioperative haemorrhage following cardiac surgery using the thrombo-elastometry point of care test. Receives: Device: Thrombo-elastometry POC testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-utility ratio
incremental cost per incremental life year and incremental costs per incremental QALY
Measured: one year
Secondary outcomes (5)
incremental cost effectiveness ratio
incremental cost effectiveness ratio : difference in costs divided by the difference in mortality and serious adverse events
Measured: one year
Complication rates
Parameters followed during hospitalization are: volume of postoperative bleeding, allogeneic blood product transfusion, blood cell count, postoperative complications: surgical reexploration, acute kidney injury, need for renal replacement therapy, organ failure, acquired infections, mechanical ventilation duration, intensive care, and in hospital length of stay, death.
Measured: one year
Complication rates
The major complications that can occur within 12 months are: death, cardio-thoracic surgical intervention, acute kidney injury, need for renal replacement therapy, any serious illness diagnosis.
Measured: one year
Evaluation survey
Evaluation survey regarding the context and the parameters that impacted the physician's decision, which will be used a sub-group of 100 patients.
Measured: Day 1
The location of the Thrombo-elastometry POC testing
The location of the Thrombo-elastometry POC testing (operative room or laboratory)
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start3 Jan 2017
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,098 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Bertrand Rozec, PUPH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02972684
- Sponsor's protocol ID
- RC16_0009
- Acronym
- IMOTEC
- Status last verified
- Feb 2020
- First submitted
- 2 Nov 2016
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751.
PubMed 31694845Vourc'h M, Boissier E, Lakhal K, Grosjean S, Labaste F, Robin E, Bougle A, Mattei M, Morel J, Wurtz V, Mertes PM, Zlotnik D, Lagier D, Beurton A, Rineau E, Fischer MO, May MA, Medard A, Guimbretiere G, Durand-Zaleski I, Pere M, Rozec B, Rigal JC. Cost-utility of point-of-care viscoelastic hemostatic assays in the management of bleeding during cardiac surgery: A single-blinded prospective multicenter stepped wedge cluster randomized trial in French context. Anaesth Crit Care Pain Med. 2026 May;45(3):101704. doi: 10.1016/j.accpm.2025.101704. Epub 2025 Nov 20.
PubMed 41274376
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-Utility Analysis of Management of Peri Operative Haemorrhage Following Cardiac Surgery Using Conventional Blood Coagulation Tests or Thrombo-elastographic Point of Care Test - IMOTEC
- ClinicalTrials.gov ID
- NCT02972684
- Acronym / sponsor ID
- IMOTEC / RC16_0009
- Conditions
- C.Surgical Procedure; Cardiac, Blood Transfusion, Blood Coagulation Disorders, Bypass, Cardiopulmonary, Hemostatic
- Keywords
- Cardiopulmonary Bypass, Hemorrhage, blood transfusion, Point-of-care test, health economics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,098 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 23 Nov 2016 (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.
Peri operative haemorrhage following cardio Pulmonary Bypass may occur in 5 to 10% of cardiac surgical interventions.
Treatment of such complication often necessitates various combinations therapeutic intervention including allogenic blood products administration, drug use and/or surgical intervention. All are expensive treatment and decision making is guided by patient clinical status and biological tests of the haemostatic function.
A key point is the time frame of the clinical process. Therapeutic choices have to be done as fast as possible to minimize bleeding consequences on patient haemodynamic and physiological status. Conventional coagulation test results availability time usually exceed 45' after blood drawing. In such situation, the results may not reflect precisely the coagulation system current state. This downside is often counterbalanced by clinicians empirical choices preceding lab test results knowledge that may conduct to inappropriate treatment, blood product overuse and undue expense.
Viscoelastic point of care test may compensate for the limitations of conventional coagulation tests. In perioperative haemorrhage, faster and more precise information about haemostatic function may help for more accurate therapeutic choices.
The IMOTEC study aims to compare haemorrhage management following cardiac surgery using conventional blood coagulation tests or thrombo-elastogaphic point of care test.
Primary endpoint is a cost utility analysis of the technology and secondary endpoints include blood component transfusion, postoperative bleeding , thoracic re-intervention, postoperative infection (any cause), organ failure, in hospital length of stay and death.
Detailed description
The research is a real life, prospective, single blinded stepped wedge randomized study.
Inclusion after informed consent of adult patient having cardio-vascular surgical procedure using cardiopulmonary bypass and meeting inclusion criterion "bleeding".
After meeting inclusion criterion patients are managed either using conventional blood coagulation tests or using thrombo-elastometry POC test and predefined therapeutic interventions described in a specific algorithm.
Other elements of patient clinical management follow usual center standard care .
Follow up of EQ-5D and clinical evaluations are performed at one , 6 and 12 months after inclusion.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional coagulation management | No intervention | –management of perioperative haemorrhage following cardiac surgery using conventional blood coagulation tests. |
| Thrombo-elastometry POC testing | Experimental | Device: Thrombo-elastometry POC testingmanagement of perioperative haemorrhage following cardiac surgery using the thrombo-elastometry point of care test. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Blood Coagulation test sampling indication for intra or post-operative bleeding defined as follow:
- intra-operative post CPB bleeding; evaluation more than 10min after heparin reversal by protamin.
- Postoperative period , evaluation in post operative care environment after 30min stabilization period
Key exclusion criteria (8 listed)
- Known congenital bleeding disorder
- Redo surgery for patient previously included in the study
- Implantation of Cardiac support device, Extra Corporeal Membrane Oxygenation (ECMO) Extra Corporeal Life support (ECLS), uni or bi-ventricular artificial hearts.
- Indication for post-CPB ECMO or ECLS
- blood transfusion refusal
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 |
|---|---|---|
| Thrombo-elastometry POC testingUse of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage | Device | Thrombo-elastometry POC testing |
Primary outcome
Cost-utility ratio
Time frame: one year
incremental cost per incremental life year and incremental costs per incremental QALY
5 secondary outcomes
incremental cost effectiveness ratio
Time frame: one year
Complication rates
Time frame: one year
Complication rates
Time frame: one year
Evaluation survey
Time frame: Day 1
The location of the Thrombo-elastometry POC testing
Time frame: three years
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 13 Feb 2020.
- Background: PubMed 31694845Rigal JC, Boissier E, Lakhal K, Riche VP, Durand-Zaleski I, Rozec B. Cost-effectiveness of point-of-care viscoelastic haemostatic assays in the management of bleeding during cardiac surgery: protocol for a prospective multicentre pragmatic study with stepped-wedge cluster randomised controlled design and 1-year follow-up (the IMOTEC study). BMJ Open. 2019 Nov 5;9(11):e029751. doi: 10.1136/bmjopen-2019-029751.
- Derived from this study: PubMed 41274376Vourc'h M, Boissier E, Lakhal K, Grosjean S, Labaste F, Robin E, Bougle A, Mattei M, Morel J, Wurtz V, Mertes PM, Zlotnik D, Lagier D, Beurton A, Rineau E, Fischer MO, May MA, Medard A, Guimbretiere G, Durand-Zaleski I, Pere M, Rozec B, Rigal JC. Cost-utility of point-of-care viscoelastic hemostatic assays in the management of bleeding during cardiac surgery: A single-blinded prospective multicenter stepped wedge cluster randomized trial in French context. Anaesth Crit Care Pain Med. 2026 May;45(3):101704. doi: 10.1016/j.accpm.2025.101704. Epub 2025 Nov 20.
- Individual participant dataSharing planned: No
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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.
Bertrand Rozec, PUPH principal investigator
Nantes University Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrombo-elastometry POC testing in people with C.Surgical Procedure; Cardiac and Blood Transfusion, run by Nantes University Hospital at 15 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 8 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 13 Feb 2020. 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. 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.
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?
Cost-utility ratio (time frame: one year). 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 NCT02972684, which also lists 2 linked publications.
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 13 Feb 2020.