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NCT Number: NCT02761564

SvO2 Trigger in Transfusion Strategy 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.

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Key information

Conditions

Undergoing Nonemergent Cardiac Surgery Anemia 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) Hematologic Diseases Hemic and Lymphatic Diseases Hemodynamic and Respiratory Stability Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHMontpellier

Montpellier, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Red blood cell tranfusion

Other

Red blood cell transfusion according to transfusion guidelines.

ScvO2 measure

Other

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%.

Primary outcomes

  1. Number of patients transfused

    Time frame: Between 1 and 28 days (ICU stay)

    Number of patients transfused during ICU stay

Secondary outcomes

  1. Number of patients transfused

    Time frame: Day 28

    Number of patients transfused on day 28

  2. Number of blood units transfused in ICU

    Time frame: Between 1 and 28 days (ICU stay)

    Number of blood units transfused during ICU stay

  3. Number of blood units transfused on day 28

    Time frame: Day 28

    Number of blood units transfused

Other outcomes

  1. Incidence of mortality

    Time frame: Day 28

    Incidence of 28-day mortality

  2. total duration of mechanical ventilation

    Time frame: Day 1 to 28

    total duration of mechanical ventilation on D28

  3. length of stay in ICU

    Time frame: Day 1 to 28

    The length of stay in ICU

  4. length of hospital stay

    Time frame: Between 1 and 28 days

    The length of stay during hospitalization (Between 1 and 28 days)

  5. Organ failure incidence

    Time frame: Day 1 to 28

    incidence of organ failure at day 28

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Restrictive Transfusion Strategy Early After Cardiac Surgery

Acronym: ReTSEACS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 4, 2016
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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