On-pump Cardiac SurgeryCOLTRANENCT06425614
COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
A study testing Autotransfusion in people with On-pump Cardiac Surgery and High Risk for Bleeding, run by University Hospital, Bordeaux at 10 sites in France.
Trial summary
Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- On-pump Cardiac Surgery, High Risk for Bleeding, Autotransfusion
- What is being tested?
- Autotransfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 10 sitesFrance
- Study dates
- 15 Jul 2024to 15 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as:
- Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s))
- Primary or redo ascending aorta surgery
- Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery
- Free, informed and written consent signed by the participant and the investigator
Who cannot join
- Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor)
- Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis
- Malignant tumor
- Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS)
- Emergency cardiac surgery
- Heart transplantation
Show all 19Show fewer
- Implantation or patients under ventricular assist device (VAD)
- Patients with two or more previous sternotomy
- Surgery procedure requiring circulatory arrest and/or profound hypothermia (<32°C)
- Active infective endocarditis
- Cardiac surgical procedure for benign or malignant cardiac tumors
- Patients with known acquired or constitutional coagulopathy requiring specialist management
- End stage renal disease
- Preoperative haemoglobin level less than 10 g/dL
- Preoperative platelet count < 100 G/L
- Persons participating in another interventional research including a period of exclusion that is still ongoing
- Pregnant or breastfeeding women
- Persons placed under judicial protection
- Patients deprived of liberty
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire
Bordeaux, France, 33076
Alexandre Ouattara, MD, PhD, 0557656866 ext. +33, alexandre.ouattara@chu-bordeaux.fr
Antoine BEURTON, 0557656866 ext. +33, antoine.beurton@chu-bordeaux.fr
- Not yet recruiting
HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation
Bron, 69677
Jean-Luc FELLAHI, MD, PhD, 0472118933, jean-luc.fellahi@chu-lyon.fr
- Recruiting
CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve
Montpellier, 34295
Philippe GAUDARD, MD, 0467336733, p-gaudard@chu-montpellier.fr
- Recruiting
CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque
Nantes, 44093
Bertrand ROZEC, MD, PhD, 0240165304, bertrand.rozec@chu-nantes.fr
- Not yet recruiting
Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale
Paris, 75651
Aude Carillion, MD, 0184827387, aude.carillion@aphp.fr
- Not yet recruiting
Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation
Paris, 75877
Sophie Provenchere, MD, 0140258355, sophie.provenchere@aphp.fr
- Not yet recruiting
Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation
Paris, 75908
Bernard Cholley, MD, PhD, 0156092515, bernard.cholley@aphp.fr
- Recruiting
CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV
Rennes, 35033
Alexandre Mansour, MD, 0299289153, alexandre.mansour@chu-rennes.fr
- Recruiting
CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale
Strasbourg, 67091
Paul-Michel MERTES, MD, PhD, 0369550444, paul-michel.mertes@chru-strasbourg.fr
- Not yet recruiting
CHU Toulouse, Hôpital Rangueil, Service Anesthésie
Toulouse, 31400
François Labaste, MD, 0561322822, labaste.f@chu-toulouse.fr
About this study
Official title: Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial
Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device.
Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection.
Read the detailed description
The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected.
The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification).
- Being tested
- Autotransfusion
- Keywords
- cardiac surgery, bleeding, autotransfusion, cardiopulmonary bypass, perioperative haemostasis, Universal Definition of Perioperative Bleeding, filtration-based autotransfusion, centrifugation-based autotransfusion
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutotransfusionProcedure or surgery
ANTIFIBRINOLYTIC THERAPY :
tranexamic acid as antifibrinolytic therapy : dose after anaesthesia induction followed by continuous intravenous infusion until end
INTRAOPERATIVE MANAGEMENT :
- Routine monitoring : five lead-ECG, pulse oximeter, non-invasive arterial pressure will be instituted. A peripheral venous catheter and an arterial catheter
- The general anaesthesia :
- propofol and Remifentanil or sufentanil both simultaneously administered .
- monitoring of the bispectral index
- Triple lumen central venous catheter
- Heparinization (300 UI/kg)
- Aortic and right auricular cannulations
TRANSFUSION PROTOCOL :
- During CPB, PRBC transfusion if necessary
- In the postoperative period if necessary
In bleeding patients:
The perioperative use of blood products will be managed according to results of conventional haemostasis tests or viscoelastic point of care tests when available in the center.
| Study group | Role | What they receive |
|---|---|---|
| Autotransfusion by filtration | Experimental | new filtration-based autotransfusion (SAME I-SEP device) Receives: Procedure: Autotransfusion |
| Autotransfusion by centrifugation | Other | centrifugation-based autotransfusion (routinely used in cardiac surgery centers) Receives: Procedure: Autotransfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative bleeding
The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding.
Measured: At the end of Day 1
Secondary outcomes (8)
total blood loss
Total blood loss from chest tubes within 12 and 24 postoperative hours and up to chest tubes removal (maximum 5 postoperative days)
Measured: Hours 12, Hours 24, up to 5 after operatives days
surgical re-exploration
Surgical re-exploration for excessive bleeding within 5 postoperative days
Measured: Day 0-Day 5,
Sternal closure
Delayed sternal closure
Measured: Hours 12
Overall quality of perioperative haemostasis : Use of blood
Perioperative use of blood products and/or plasma derivatives within 2 postoperative days including PRBC, PLT, FFP, fibrinogen concentrate, PCCs, rFVIIa
Measured: Day 0-Day 2,
Perioperative biological hemostasis
Coagulation tests (PT, aPTT, fibrinogen level) preoperatively, at the end of the surgery (+ thrombin time or ACT ), at arrival in ICU and at POD1, 3 and 5
Measured: Pre-inclusion - Day 5
Complete blood count
Complete blood count preoperatively, at the end of the surgery, at arrival in ICU and at POD1, 3 and 5.
Measured: Pre-inclusion - Day 5
ICU and hospital length of stay
calculated ICU and hospital free days
Measured: End of study or early termination- Day 30
Early postoperative morbidity within 30 postoperative days
Cardiovascular: need for inotropes and/or vasopressors intravenous infusion >24 hours, need for short-term mechanical circulatory support, occurrence of atrial fibrillation and/or ventricular fibrillation/tachycardia, high grade atrioventricular bloc, myocardial infarction, tamponade, symptomatic thromboembolic events.
Respiratory: duration of mechanical ventilation, re-intubation, ARDS according the Berlin criteria, need for VV ECMO Renal: Kidney Disease Improving Global Outcomes stage (KDIGO) ≥2; need for renal replacement therapy. Serum electrolytes and renal function preoperatively, at arrival in ICU and at POD1, 3 and 5.
Neurology: transient and permanent stroke, epilepsy, confusion Infectious: mediastinitis, septic shock, pneumopathy and bacteremia Abdominal: mesenteric ischemia, upper and/or lower gastrointestinal bleeding. Liver function tests preoperatively, at arrival in ICU and at POD1, 3 and 5.
30-day all-cause mortality
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start15 Jul 2024
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Feb 2027 (estimated)
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 On-pump Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre clinical trial, Randomized, Comparative, controlled, single blinded, superiority design, two groups.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 570 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandre Ouattara, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06425614
- Sponsor's protocol ID
- CHUBX 2022/22
- Other IDs
- 2022-A02566-39
- Acronym
- COLTRANE
- Status last verified
- Jun 2025
- First submitted
- 12 Jan 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be made available upon reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.
Publications
Beurton A, Mansour A, Benard A, Pernot M, Brett VE, Batsale C, Aitgougam A, Cordon A, Mouton C, Fresselinat A, Robert G, Imbault J, Nesseler N, Ouattara A. Centrifugation versus filtration-based cell salvage: impact on perioperative bleeding in cardiac surgery-the COLTRANE randomised clinical trial - study protocol. BMJ Open. 2025 Jul 16;15(7):e099423. doi: 10.1136/bmjopen-2025-099423.
PubMed 40669902
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06425614
- Acronym / sponsor ID
- COLTRANE / CHUBX 2022/22
- Keywords
- cardiac surgery, bleeding, autotransfusion, cardiopulmonary bypass, perioperative haemostasis, Universal Definition of Perioperative Bleeding, filtration-based autotransfusion, centrifugation-based autotransfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 22 May 2024 (actual)
- 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.
Despite significant advances in patient blood management, cardiac surgery remains a surgical procedure at high risk for bleeding. Numerous perioperative blood conservation strategies have been developed for limiting the use of blood products. Among them, the processing of shed blood and residual cardiopulmonary bypass circuit volume with autotransfusion device is routinely used. Conventional centrifugation-based autotransfusion devices actually available only recover red blood cells while platelets and coagulation factors are almost totally lost. Consequently, large amounts of intraoperative cell salvage could significantly alter perioperative haemostasis. The SAME autotransfusion device (i-SEP, France) is a new and innovative filtration-based autotransfusion device able to recover erythrocytes, leukocytes but also platelets. By offering the opportunity to re-infuse to patients their own platelets in addition red blood cells, significantly improve perioperative haemostasis with this new device is expected. The purpose of the COLTRANE trial is to compare the quality of the perioperative haemostasis in cardiac surgical patients for whom intraoperative cell salvage will be performed using either the SAME autotransfusion device or conventional centrifugation-based device.
Because allogenic transfusion of blood products as well as surgical re-exploration for excessive bleeding are associated with poor outcomes and prolonged length of stay, the use of filtration-based SAME device by maintaining perioperative haemostasis could improve outcomes and reduce length of stay of high risk patients. The fact that patients receive their own platelets should also limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection.
Detailed description
The SAME device is a new and innovative filtration-based autotransfusion device able to recover both erythrocytes and platelets. A multicentre single-arm clinical feasibility and safety trial conducted by our group, using SAME device on 50 cardiac surgical patients reported erythrocyte yield per cycle of 89%, post-treatment hematocrit of 43% with an excellent washing performance. In addition, the device recovered 52% of platelets, that were found unaltered by the device as demonstrated by a limited platelet activation and a strong response to thrombin-pathway stimulation assessed by flow cytometry. By offering the opportunity to re-infuse to the patients their own platelets in addition to their RBC, this new device might significantly improve perioperative haemostasis and thus decrease the need for blood products. It is well established that severe postoperative bleeding and blood products transfusion lead to increase morbidity and mortality. Consequently, an improvement of postoperative outcomes and a decrease in intensive care unit (ICU) and hospital length of stay may be expected. The fact that patients receive their own platelets should limit the risk of allo-immunization and immunomodulation which is recognized as one of the underlying mechanisms of perioperative increased risk of infection. Consequently, a reduction of infectious complication may be also expected.
The purpose of COLTRANE trial is to test the hypothesis that the intraoperative use of the filtration-based SAME autotransfusion device could improve perioperative haemostasis thereby reducing the proportion of patients exhibiting clinically significant perioperative bleeding (moderate to massive bleeding according the Universal Definition of Perioperative Bleeding (UDPB) classification).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentre clinical trial, Randomized, Comparative, controlled, single blinded, superiority design, two groups.
| Arm | Type | Receives |
|---|---|---|
| Autotransfusion by filtration | Experimental | Procedure: Autotransfusionnew filtration-based autotransfusion (SAME I-SEP device) |
| Autotransfusion by centrifugation | Other | Procedure: Autotransfusioncentrifugation-based autotransfusion (routinely used in cardiac surgery centers) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (≥18 yr) affiliated or beneficiary of a social security scheme and undergoing on-pump cardiac surgery at high risk for bleeding with autotranfusion indication defined as:
- Primary or redo combined cardiac procedures (2 valves or more, valve(s) and coronary artery bypass grafting(s))
- Primary or redo ascending aorta surgery
- Primary or redo isolated coronary artery bypass grafting (iCABG) involving 3 or more grafts using the internal mammary artery
- Free, informed and written consent signed by the participant and the investigator
Key exclusion criteria (19 listed)
- Preoperative therapy by P2Y12 receptor inhibitors (within 5 preoperative days for clopidogrel, ticagrelor or ticlopidine, within 7 preoperative days for prasugrel, and within one preoperative hour for cangrelor)
- Preoperative treatment by active anticoagulant drug (within 5 preoperative days for VKA, 4 days for dabigatran, 3 days for rivaroxaban and apixaban, 24 hours for therapeutic LMWH, 36 hours for therapeutic fondaparinux, 12 hours for prophylactic LMWH, 24 hours for prophylactic fondaparinux, 4 hours for unfractionated heparin Sepsis
- Malignant tumor
- Immunocompromised patients (steroids, immunosuppressive drugs, ongoing treatment for solid tumor or hematologic malignancy, primary immunodeficiency disorders, AIDS)
- Emergency cardiac surgery
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 |
|---|---|---|
| AutotransfusionANTIFIBRINOLYTIC THERAPY : tranexamic acid as antifibrinolytic therapy : dose after anaesthesia induction followed by continuous intravenous infusion until end INTRAOPERATIVE MANAGEMENT : * Routine monitoring : five lead-ECG, pulse oximeter, non-invasive arterial pressure will be instituted. A peripheral venous catheter and an arterial catheter * The general anaesthesia : * propofol and Remifentanil or sufentanil both simultaneously administered . * monitoring of the bispectral index * Triple lumen central venous catheter * Heparinization (300 UI/kg) * Aortic and right auricular cannulations TRANSFUSION PROTOCOL : * During CPB, PRBC transfusion if necessary * In the postoperative period if necessary In bleeding patients: The perioperative use of blood products will be managed according to results of conventional haemostasis tests or viscoelastic point of care tests when available in the center. | Procedure or surgery | Autotransfusion by centrifugation, Autotransfusion by filtration |
Primary outcome
Perioperative bleeding
Time frame: At the end of Day 1
The proportion of patients with clinically significant (moderate to massive) perioperative bleeding according to the Universal Definition for Perioperative Bleeding.
8 secondary outcomes
total blood loss
Time frame: Hours 12, Hours 24, up to 5 after operatives days
surgical re-exploration
Time frame: Day 0-Day 5,
Sternal closure
Time frame: Hours 12
Overall quality of perioperative haemostasis : Use of blood
Time frame: Day 0-Day 2,
Perioperative biological hemostasis
Time frame: Pre-inclusion - Day 5
Complete blood count
Time frame: Pre-inclusion - Day 5
ICU and hospital length of stay
Time frame: End of study or early termination- Day 30
Early postoperative morbidity within 30 postoperative days
Time frame: Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 40669902Beurton A, Mansour A, Benard A, Pernot M, Brett VE, Batsale C, Aitgougam A, Cordon A, Mouton C, Fresselinat A, Robert G, Imbault J, Nesseler N, Ouattara A. Centrifugation versus filtration-based cell salvage: impact on perioperative bleeding in cardiac surgery-the COLTRANE randomised clinical trial - study protocol. BMJ Open. 2025 Jul 16;15(7):e099423. doi: 10.1136/bmjopen-2025-099423.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be made available upon reasonable request to qualified researchers, following review and approval by the study sponsor and ethics committee.
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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.
Alexandre Ouattara, MD, PhD principal investigator
University Hospital, Bordeaux
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autotransfusion in people with On-pump Cardiac Surgery and High Risk for Bleeding, run by University Hospital, Bordeaux 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 5 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandre Ouattara, MD, PhD (0557656866 ext. +33, alexandre.ouattara@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative bleeding (time frame: At the end of Day 1). 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 NCT06425614, 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 11 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.