Using a new device to recover blood components during cardiac surgery
Centrifugation-based Versus Filtration-based Intraoperative Cell Salvage on Quality of Perioperative Haemostasis in Cardiac Surgery: A Randomized Clinical Trial
This study is testing a new device that collects and recycles blood components during heart surgery to see if it can help patients recover better and need fewer blood transfusions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 570 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 10 sites (Bordeaux, France and 9 other locations) |
| Trial ID | NCT06425614 on ClinicalTrials.gov |
What this trial studies
The COLTRANE trial investigates the use of a novel filtration-based autotransfusion device, known as SAME, during on-pump cardiac surgeries that are at high risk for bleeding. This device aims to recover not only red blood cells but also platelets and leukocytes from shed blood, potentially improving perioperative haemostasis. By re-infusing patients with their own platelets, the study seeks to reduce the need for blood product transfusions and minimize postoperative complications. The trial will assess the safety and feasibility of this approach in a multicenter setting involving several hospitals in France.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients undergoing high-risk on-pump cardiac surgeries with indications for autotransfusion.
Not a fit: Patients who have recently taken anticoagulant medications or P2Y12 receptor inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve patient outcomes by reducing postoperative bleeding and the need for blood transfusions.
How similar studies have performed: Other studies have shown promising results with similar autotransfusion approaches, but the use of the SAME device represents a novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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 * 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
Where this trial is running
Bordeaux, France and 9 other locations
- CHU de Bordeaux, Hôpital cardiologique Haut Lévêque - GH Sud, Service Anesthésie Réanimation Cardiovasculaire — Bordeaux, France, France (Recruiting)
- HOSPICES CIVILS DE LYON, Hôpital Louis Pradel, Service Anesthésie Réanimation — Bron, France (Not_yet_recruiting)
- CHU MONTPELLIER, Hôpital Arnaud de Villeneuve, Service Anesthésie Réanimation Arnaud de Villeneuve — Montpellier, France (Recruiting)
- CHU Nantes, Service Anesthésie Réanimation de chirurgie cardiaque — Nantes, France (Recruiting)
- Groupe Hospitalier Pitié Salpêtrière, APHP, Service Anesthésie Réanimation chirurgicale — Paris, France (Not_yet_recruiting)
- Hôpital Bichat-Claude Bernard, APHP, Service Anesthésie Réanimation — Paris, France (Not_yet_recruiting)
- Hôpital Européen Georges Pompidou, AP-HP, Service Anesthésie Réanimation — Paris, France (Not_yet_recruiting)
- CHU Rennes, Hôpital Pontchaillou, Service Anesthésie Réanimation 3-Réanimation CTCV — Rennes, France (Recruiting)
- CHRU STRASBOURG, Nouvel Hôpital Civil, Service Anesthésie Réanimation chirurgicale — Strasbourg, France (Recruiting)
- CHU Toulouse, Hôpital Rangueil, Service Anesthésie — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexandre Ouattara, MD, PhD — University Hospital, Bordeaux
- Study coordinator: Alexandre Ouattara, MD, PhD
- Email: alexandre.ouattara@chu-bordeaux.fr
- Phone: 0557656866
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.