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

Cardiac Surgery Clinical Trial

— PITT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02963883
• Other study ID #: PI2016_843_0015
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 28, 2020

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 28, 2020
• Est. primary completion date: May 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• SVO2 group / control group

Locations

Country	Name	City	State
France	CHU Amiens Picardie	Amiens
France	Caen	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	stroke	stroke, defined by a computed tomography documentation	15 days
Secondary	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
Secondary	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
Secondary	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
Secondary	infectious complications	infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents	15 days
Secondary	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
Secondary	lactate Rate		15 days
Secondary	central venous O2 saturation (SVO2)		15 days
Secondary	SOFA score (sepsis organ failure assessment)		15 days
Secondary	BNP Rate		15 days
Secondary	Death		15 days
Secondary	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
Secondary	Rate of lactate	Rate of lactate	15 days
Secondary	central venous O2 saturation (SVO2)	central venous O2 saturation (SVO2)	15 days
Secondary	SOFA score (sepsis organ failure assessment)	SOFA score (sepsis organ failure assessment)	15 days
Secondary	Rate BNP	Rate BNP	15 days