Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery (PITT)

Erythrocyte Transfusion Based on the Measurement of Central Venous Oxygen Saturation in Postoperative Cardiac Surgery: a Bicentric, Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Surgery
• Intervention / Treatment: Other: SVO2 group / control group

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.

• Study Type: Interventional
• Enrollment (Actual): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens Picardie
  • Caen, France
    • Caen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SVO2 group; After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells by the individual value of ScvO2, whose value must be greater than 70% after elimination of hypovolemia, hypotension or hypoxemia.	Other: SVO2 group / control group
Active Comparator: control group; After optimization of oxygenation and blood volume, concentrate transfusion (s) of red blood cells based on the hemoglobin values, as recommended by the National Health Authority for Anesthesiology, Surgery, Emergency (November 2014 ): transfusion threshold of <9 g / dl for patients with cardiovascular antecedents.	Other: SVO2 group / control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients transfused	Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group	15 dys

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute pulmonary edema due to the overload	acute pulmonary edema due to overload or TACO, defined as acute pulmonary edema overload confirmed by clinical examination and echocardiography and leading to medical treatment	15 days
lesional pulmonary edema or TRALI,	lesional pulmonary edema or TRALIassociating acute respiratory distress within 6 hours of transfusion, bilateral infiltrates on chest radiograph, but without respiratory or elevated left ventricular load conditions precedent to echocardiography, and possibly confirmed by tests biological HLA	6 h
myocardial infarction	myocardial infarction, defined by elevated serum troponin dosing greater than 10 times the 99th percentile associated with electrocardioscopic changes (appearance of new Q waves or left bundle branch block), ultrasound (appearance of segmental disorder myocardial kinetics) or angiographic (occlusion of a coronary artery or bypass surgery), as defined by the European society of cardiology in 2012,	15 days
stroke	stroke, defined by a computed tomography documentation	15 days
acute renal failure,	acute renal failure, defined as an increase of at least 50% and / or 26.5 micromol / l of postoperative serum creatinine with respect to the preoperative baseline value and / or urine output less than 0.5 mL / kg / hr about 6 hours (definition of the international society of nephrology KDIGO)	15 days
immunological complications including allo-immunization	immunological complications including allo-immunization, immunological incompatibility and hemolytic accidents involving clinical symptoms (chills, fever, back pain), increased serum bilirubin, decreased the haptoglobinemy the positivization direct antiglobulin test ( DAT), or even looking for irregular antibodies as well as disseminated intravascular coagulation, renal failure, anuria or death in case of conflict in the ABO system,	15 days
allergic complications including anaphylactic shock	allergic complications including anaphylactic shock involving care in intensive care with intravenous injection of adrenaline, vis-à-vis precautions subsequent transfusions and biological investigations and immediate allergy and distance	15 days
infectious complications	infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents	15 days
metabolic complications including febrile non-haemolytic reactions	metabolic complications including febrile non-haemolytic reactions, haemosiderosis and massive transfusion syndrome with hypocalcemia, acid-base imbalance, hyperkalemia, hemostasis disorders and hypothermia	15 days
lactate Rate		15 days
central venous O2 saturation (SVO2)		15 days
SOFA score (sepsis organ failure assessment)		15 days
BNP Rate		15 days
Death		15 days
Cost reduction of transfusion	Cost reduction of transfusion support by reducing the number of PRBC transfusions, including costs related to medical and nursing time, biological examinations pre and post-transfusion, and packed red blood cells.	15 days
Rate of lactate	Rate of lactate	15 days
central venous O2 saturation (SVO2)	central venous O2 saturation (SVO2)	15 days
SOFA score (sepsis organ failure assessment)	SOFA score (sepsis organ failure assessment)	15 days
Rate BNP	Rate BNP	15 days

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Osama Abou Arab, Doctor, CHU Amiens-Picardie

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): May 28, 2020
• Study Completion (Actual): May 28, 2020

Study Registration Dates

• First Submitted: November 10, 2016
• First Submitted That Met QC Criteria: November 10, 2016
• First Posted (Estimate): November 15, 2016

Study Record Updates

• Last Update Posted (Actual): May 29, 2020
• Last Update Submitted That Met QC Criteria: May 28, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: ScVO2; Post operative red cell transfusion
• Other Study ID Numbers: PI2016_843_0015