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SvO2 Trigger in Transfusion Strategy After Cardiac Surgery

Restrictive Transfusion Strategy Early After Cardiac Surgery

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02761564
Acronym
ReTSEACS
Enrollment
100
Registered
2016-05-04
Start date
2016-10-06
Completion date
2018-10-17
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia (<9g/dL) Requiring Blood Transfusion, Bleeding Graded as Insignificant, Mild, Moderate of Universal Definition of Perioperative Bleeding, Central Venous Catheter on the Superior Vena Cava (to Perform ScVO2 Measure), Hemodynamic and Respiratory Stability, Undergoing Nonemergent Cardiac Surgery

Keywords

Cardiac surgery, Blood transfusion, ScvO2

Brief summary

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.

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.

Interventions

OTHERRed blood cell tranfusion

Red blood cell transfusion according to transfusion guidelines.

OTHERScvO2 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%.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients transfusedBetween 1 and 28 days (ICU stay)Number of patients transfused during ICU stay

Secondary

MeasureTime frameDescription
Number of patients transfusedDay 28Number of patients transfused on day 28
Number of blood units transfused in ICUBetween 1 and 28 days (ICU stay)Number of blood units transfused during ICU stay
Number of blood units transfused on day 28Day 28Number of blood units transfused

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNorddine ZEOURAL, MD

University Hospital, Montpellier

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026