SvO2 Trigger in Transfusion Strategy After Cardiac Surgery (ReTSEACS)

Restrictive Transfusion Strategy Early After Cardiac Surgery

Current international guidelines suggest a restrictive transfusion strategy, setting that Hb level at 7 g/dl is a reasonable threshold. However, the idea of having only one threshold for all the patients has been challenged by authors, suggesting a more liberal strategy for certain cases. At the moment, there is no other parameter considered accurate enough to be taken into consideration for transfusion strategy management.

This study is to use ScVO2, a current, easily accessible parameter, before blood transfusion in order to stratify its indication after cardiac surgery.

Monocentric, randomised, single blind study (patient not aware of the group assignments) Patient inclusion will be made in ICU if the physician decides to perform blood transfusion according to standard transfusion strategy to treat a postoperative anemia (Hb<9g/dL).

Every patient will go through randomization to be placed in one of the two groups of the study: either the one whose transfusion strategy is adjusted by the pretransfusion ScvO2 (group ScvO2), or the control group.

Our main objective is to evaluate the impact of a new transfusion strategy founded on guidelines, but provided ScvO2 is less than 65%, on the incidence of red blood cells transfusion for anemia early after cardiac surgery.

Study Overview

• Status: Completed
• Conditions: Undergoing Nonemergent Cardiac Surgery; Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure); Anemia (<9g/dL) Requiring Blood Transfusion; Hemodynamic and Respiratory Stability; Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding
• Intervention / Treatment: Other: ScvO2 measure; Other: Red blood cell tranfusion

Detailed Description

Currently, the rate of transfusion of cardiac surgery patients is approximately 50%. The decision to transfuse is based on the hemoglobin (Hb), the transfusion threshold from 7 to 9 g / dL seems to be reasonable, based on clinical parameters, as well as patient history, as the degree of coronary stenosis . Several randomized studies have shown that a restrictive transfusion strategy was superior to a liberal strategy.

ScvO2 is a parameter reflecting the balance between transport O2 and O2 in tissue consumption, which Hb is one of the determinants. It requires that a levy on central venous used frequently for such patients. ScvO2 could make better account of the actual tolerance of anemia that the only value of Hb and the patient's clinical characteristics.

We therefore hypothesize that ScvO2 can help with the decision of RBC transfusions after heart surgery.

Primary and secondary endpoints Principal: To assess the value of ScvO2 threshold (65%) in the restrictive transfusion strategy on the incidence of transfusion after cardiac surgery.

secondary:

• Assess the impact of transfusion strategy based on ScvO2 on the number of transfused patients at D28
• Assess the impact of transfusion strategy based on ScvO2 on the number of cells transfused concentrates.
• Assess the impact of transfusion strategy based on ScvO2 on mortality or incidence of disease events such as cardiac complications, renal, respiratory or neurological dysfunction in the immediate aftermath of surgery.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 18 years
• Patients admitted to intensive care after heart surgery
• Anemic patient (Hb < 9 g/dL)
• Patient with a central venous catheter in the territory SVC

Exclusion Criteria:

• Patient with acute bleeding defined as a postoperative bleeding over 1000 ml in 12 hours or the need for a recovery operation for hemostasis or the transfusion of blood units over 4
• Patient with severe sepsis or septic shock criteria defined by the Surviving Sepsis compaign

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ScVO2 group; Anemia (<9g/dL) requiring blood transfusion Measure of ScvO2 : ScVO2 is measured using the central venous catheter placed in the superior vena cava. Transfusion is performed if the ScVO2 is inferior or equal to 65%.	Other: ScvO2 measure; ScvO2 (oximetry) is measured at the distal lumen of the central venous catheter placed in the superior vena cava. Transfusion is performed if ScvO2 is inferior or equal to 65%.
OTHER: Control group; Anemia (<9g/dL) requiring blood transfusion : Transfusion is performed following national guidelines for red blood cell transfusion	Other: Red blood cell tranfusion; Red blood cell transfusion according to transfusion guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients transfused	Number of patients transfused during ICU stay	Between 1 and 28 days (ICU stay)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients transfused	Number of patients transfused on day 28	Day 28
Number of blood units transfused in ICU	Number of blood units transfused during ICU stay	Between 1 and 28 days (ICU stay)
Number of blood units transfused on day 28	Number of blood units transfused	Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of mortality	Incidence of 28-day mortality	Day 28
total duration of mechanical ventilation	total duration of mechanical ventilation on D28	Day 1 to 28
length of stay in ICU	The length of stay in ICU	Day 1 to 28
length of hospital stay	The length of stay during hospitalization (Between 1 and 28 days)	Between 1 and 28 days
Organ failure incidence	incidence of organ failure at day 28	Day 1 to 28

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Norddine ZEOURAL, MD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 6, 2016
• Primary Completion (ACTUAL): September 17, 2018
• Study Completion (ACTUAL): October 17, 2018

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 2, 2016
• First Posted (ESTIMATE): May 4, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac surgery; Blood transfusion; ScvO2
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 9655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED