Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Feb 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to blood transfusions for patients undergoing heart surgery. The goal is to see if a method that adjusts transfusion needs based on a specific measurement (called SvO2) can help reduce the number of patients who need red blood cell transfusions during and after surgery. Participants will be randomly divided into two groups: one will receive standard transfusion care, while the other will have their transfusions guided by the SvO2 measurement. Researchers will compare how many people in each group end up needing a transfusion.

To join the study, participants must be between 18 and 85 years old, be anemic (with low hemoglobin levels), and be scheduled for certain types of heart surgeries. They also need to have public health insurance. Before enrolling, patients or their close relatives must sign a consent form. Those who take part can expect to receive care as usual, with some additional monitoring related to this trial. It’s important to note that pregnant or breastfeeding individuals, as well as those with certain medical conditions, cannot participate. This trial aims to improve patient care by potentially reducing the need for blood transfusions during heart surgery.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged above 18 years and under 85 years
• • Signed informed consent form from the patient or his/her close relative or surrogate (if present) before inclusion or when possible when the patient has been included in an emergency setting
• • Anaemic (Haemoglobin at inclusion ≤ 13 g/dL)
• • Operated on elective, on-pump cardiac surgery for : Coronary artery bypass graft (CABG); Aortic, mitral or tricuspid valve (replacement or repair); Ascending aorta;Left ventricle assistance device (LVAD)
• • Operated on urgent on-pump cardiac surgery for : CABG;Endocarditis;Aortic dissection; Heart transplantation
• • Subjects must be covered by public health insurance
• Exclusion Criteria:
• • Patient with no central venous catheter inserted in the superior vena cava
• • Pregnant or breast feeding patient
• • Subject unable to read or/and write
• • Participation in another interventional clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
• • Medical history of heparin-induced thrombocytopenia contraindicating heparin use during surgery
• • Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric care and persons admitted to a health or social establishment for purposes other than research