Actively Recruiting
COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
Led by University Hospital, Bordeaux · Updated on 2025-06-29
570
Participants Needed
10
Research Sites
82 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
COmbined pLaTelet and eRythrocyte AutotransfusioN During Cardiac surgEry (COLTRANE) Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients aged 18 years or older
- Affiliated or beneficiary of a social security scheme
- Undergoing on-pump cardiac surgery at high risk for bleeding with autotransfusion indicated
- Surgery includes 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 involving 3 or more grafts using the internal mammary artery
- Provided free, informed, and written consent signed by participant and investigator
You will not qualify if you...
- Preoperative use of P2Y12 receptor inhibitors within specified time frames before surgery
- Preoperative treatment with active anticoagulant drugs within specified time frames before surgery
- Presence of sepsis
- Malignant tumors
- Immunocompromised patients (on steroids, immunosuppressants, or ongoing cancer treatment)
- Emergency cardiac surgery
- Heart transplantation
- Patients with ventricular assist devices or under implantation
- Patients with two or more previous sternotomies
- Surgery requiring circulatory arrest or profound hypothermia below 326C
- Active infective endocarditis
- Cardiac surgery for benign or malignant cardiac tumors
- Known acquired or constitutional coagulopathy requiring specialist management
- End-stage renal disease
- Preoperative hemoglobin less than 10 g/dL
- Preoperative platelet count less than 100 G/L
- Participation in another ongoing interventional research
- Pregnant or breastfeeding women
- Persons under judicial protection
- Patients deprived of liberty
AI-Screening
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Trial Site Locations
Total: 10 locations
1
CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire
Bordeaux, France, France, 33076
Actively Recruiting
2
HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation
Bron, France, 69677
Not Yet Recruiting
3
CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve
Montpellier, France, 34295
Actively Recruiting
4
CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque
Nantes, France, 44093
Actively Recruiting
5
Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale
Paris, France, 75651
Not Yet Recruiting
6
Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation
Paris, France, 75877
Not Yet Recruiting
7
Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation
Paris, France, 75908
Not Yet Recruiting
8
CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV
Rennes, France, 35033
Actively Recruiting
9
CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale
Strasbourg, France, 67091
Actively Recruiting
10
CHU Toulouse, Hôpital Rangueil, Service Anesthésie
Toulouse, France, 31400
Not Yet Recruiting
Research Team
A
Alexandre Ouattara, MD, PhD
CONTACT
A
Antoine Beurton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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