Clinical trial NCT02963883: Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery
Official title: Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: ScVO2
Post operative red cell transfusion
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-11-15
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

Detailed description: Postoperative erythrocytes transfusion is associated with morbidity and excess mortality, which should lead to ask the indication for RBC transfusions only on metabolic needs. Currently, the majority of studies used to put hemoglobin values indicating red cell transfusions. Two observational studies have confirmed that a transfusion strategy based on a metabolic index (ScvO2) individual was accompanied by a different transfusion strategy than using the hemoglobin threshold values. We propose to conduct the first randomized multicenter study to evaluate erythrocyte transfusion strategy in postoperative cardiac surgery using the ScvO2 each patient versus a threshold value usually recommended for all patients.

Eligibility criteria: Inclusion Criteria:

1. Patient ≥ 18 years
2. programmed cardiac surgery
3. Central venous catheter placed in territory SVC
4. Affiliation to a social security system
5. Hemoglobin \<9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)

Exclusion Criteria:

1. Patient minor or under court protection
2. Pregnant or lactating women
3. severe acute hemorrhagic syndrome (defined by bleeding rate greater than 1.5 ml / kg / hour for 6 consecutive hours and / or surgical revision within the first 24 postoperative hours)
4. Installation of an external or internal circulatory support
5. emergency surgery (\<24 hours from admission)
6. Complex Aortic Surgery
7. Sepsis
8. Patient Refusal of transfusion (religious belief)
9. Patient under guardianship
10. Renal failure with dialysis treatment

Primary outcomes:
measure: Number of patients transfused
timeFrame: 15 dys
Secondary outcomes:
measure: acute pulmonary edema due to the overload
timeFrame: 15 days
measure: lesional pulmonary edema or TRALI,
timeFrame: 6 h
measure: myocardial infarction
timeFrame: 15 days
measure: stroke
timeFrame: 15 days
measure: acute renal failure,
timeFrame: 15 days
measure: immunological complications including allo-immunization
timeFrame: 15 days
measure: allergic complications including anaphylactic shock
timeFrame: 15 days
measure: infectious complications
timeFrame: 15 days
measure: metabolic complications including febrile non-haemolytic reactions
timeFrame: 15 days
measure: lactate Rate
timeFrame: 15 days
measure: central venous O2 saturation (SVO2)
timeFrame: 15 days
measure: SOFA score (sepsis organ failure assessment)
timeFrame: 15 days
measure: BNP Rate
timeFrame: 15 days
measure: Death
timeFrame: 15 days
measure: Cost reduction of transfusion
timeFrame: 15 days
measure: Rate of lactate
timeFrame: 15 days
measure: central venous O2 saturation (SVO2)
timeFrame: 15 days
measure: SOFA score (sepsis organ failure assessment)
timeFrame: 15 days
measure: Rate BNP
timeFrame: 15 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Caen
country: France
facility: Caen
Study officials:
affiliation: CHU Amiens-Picardie
name: Osama Abou Arab, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, Dupont H, Hanouz JL, Diouf M, Abou-Arab O. Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial. Br J Anaesth. 2022 Jan;128(1):37-44. doi: 10.1016/j.bja.2021.09.037. Epub 2021 Nov 30.