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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-05-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

SVO2 group / control group

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

SVO2 group / control group

Intervention Type OTHER

Interventions

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SVO2 group / control group

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No