Evaluating a blood transfusion strategy during cardiac surgery
Restrictive Transfusion StratEgy Adjusted by SvO2 During Cardiac Surgery: Multicenter, Single-blinded, Randomised Controlled Trial.
NA · University Hospital, Montpellier · NCT05740059
This study is testing if using a specific blood measurement during heart surgery can help reduce the number of blood transfusions needed for patients.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 676 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier (other) |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT05740059 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess whether a restrictive blood transfusion strategy, guided by central venous oxygen saturation (SvO2), can reduce the need for red blood cell transfusions in patients undergoing cardiac surgery. Adult participants will be randomly assigned to either a standard restrictive transfusion group or an SvO2-adjusted group. The study will compare the proportion of patients receiving transfusions between the two groups, focusing on the perioperative period. The hypothesis is that using SvO2 as a criterion for transfusion may lead to fewer unnecessary transfusions without increasing the risks associated with anemia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 who are undergoing elective or urgent on-pump cardiac surgery and are anemic.
Not a fit: Patients who are not anemic or those undergoing non-cardiac surgical procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of red blood cell transfusions during cardiac surgery, minimizing associated risks.
How similar studies have performed: Previous studies have shown success with similar restrictive transfusion strategies in cardiac surgery, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Montpellier
- Departement d'anesthésie et réanimation D - Arnaud de Villeneuve — Montpellier, France (RECRUITING)
Study contacts
- Study coordinator: Pascal COLSON, MD
- Email: p-colson@chu-montpellier.fr
- Phone: +33467335957
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.
Conditions: Cardiac Surgery, Cardiopulmonary Bypass, Blood transfusion, Cardiac surgery