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NCT Number: NCT02963883

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

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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Key information

Conditions

Cardiac Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens Picardie, Amiens, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient ≥ 18 years
  • programmed cardiac surgery
  • Central venous catheter placed in territory SVC
  • Affiliation to a social security system
  • Hemoglobin <9 g / dL (transfusion threshold retained by the recommendations the HAS in November 2014 for perioperative patients with cardiovascular antecedents)

Exclusion criteria

  • Patient minor or under court protection
  • Pregnant or lactating women
  • 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)
  • Installation of an external or internal circulatory support
  • emergency surgery (<24 hours from admission)
  • Complex Aortic Surgery
  • Sepsis
  • Patient Refusal of transfusion (religious belief)
  • Patient under guardianship
  • Renal failure with dialysis treatment

Treatment and study plan

SVO2 group / control group

Other

Primary outcomes

  1. Number of patients transfused

    Time frame: 15 dys

    Number of patients transfused at least one red blood cell concentrate in postoperative cardiac surgery for the ScvO2 group compared to the control group

Secondary outcomes

  1. acute pulmonary edema due to the overload

    Time frame: 15 days

    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

  2. lesional pulmonary edema or TRALI,

    Time frame: 6 h

    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

  3. myocardial infarction

    Time frame: 15 days

    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,

  4. stroke

    Time frame: 15 days

    stroke, defined by a computed tomography documentation

  5. acute renal failure,

    Time frame: 15 days

    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)

  6. immunological complications including allo-immunization

    Time frame: 15 days

    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,

  7. allergic complications including anaphylactic shock

    Time frame: 15 days

    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

  8. infectious complications

    Time frame: 15 days

    infectious complications, including bacterial infections, viral, parasitic, including by poorly known or emerging agents

  9. metabolic complications including febrile non-haemolytic reactions

    Time frame: 15 days

    metabolic complications including febrile non-haemolytic reactions, haemosiderosis and massive transfusion syndrome with hypocalcemia, acid-base imbalance, hyperkalemia, hemostasis disorders and hypothermia

  10. lactate Rate

    Time frame: 15 days

  11. central venous O2 saturation (SVO2)

    Time frame: 15 days

  12. SOFA score (sepsis organ failure assessment)

    Time frame: 15 days

  13. BNP Rate

    Time frame: 15 days

  14. Death

    Time frame: 15 days

  15. Cost reduction of transfusion

    Time frame: 15 days

    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.

  16. Rate of lactate

    Time frame: 15 days

    Rate of lactate

  17. central venous O2 saturation (SVO2)

    Time frame: 15 days

    central venous O2 saturation (SVO2)

  18. SOFA score (sepsis organ failure assessment)

    Time frame: 15 days

    SOFA score (sepsis organ failure assessment)

  19. Rate BNP

    Time frame: 15 days

    Rate BNP

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: PITT

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 15, 2016
Registry last updated
Sep 22, 2025

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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