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NCT Number: NCT07509203

ScvO2-Centered Optimisation of RED Blood Cell Transfusions

This clinical trial aims to personalise red blood cell transfusion strategies in the crtitically ill patients. The amount of transfusions needs to be minimised in order to prevent adverse events and organ dysfunctions linked to high amounts of red blood cell transfusions.

The researchers aim to investigate the efficacy and safety of measuring the central venous oxygen saturation (ScvO2) (oxygen content in a venous blood sample taken from a central line) to guide clinicians if transfusion is necessary.

The researchers aim to compare the ScvO2 guided transfusion strategy with transfusion based on the clinician's judgment (taking into consideration the patients' comorbidities and actual vital parameters).

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Key information

Conditions

Anaemia Anemia Critical Illness Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North-Pest Central Hospital- Hungarian Defense Forces Medical Center, Department of Anaesthesiology and Intensive Therapy, Budapest, Hungary

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About this study

Red blood cell transfusions are routine practice in the management of critically ill patients; 25% of patients treated in the intensive care unit receive a transfusion. Its aim is to restore adequate oxygen delivery to peripheral tissues. Transfusion has numerous potentially harmful effects and significantly increases healthcare costs. International guidelines recommend a restrictive transfusion policy. These recommendations are based on studies that use the hemoglobin level as a transfusion trigger. Hemoglobin level does not provide sufficient information about the balance between oxygen delivery and oxygen consumption, which determines tissue oxygenation. Incorporating a physiological parameter into the transfusion decision-making algorithm may ensure a personalized transfusion strategy. Clear evidence is lacking regarding the usefulness of physiological transfusion triggers in the treatment of anemia in critically ill patients. Case reports and retrospective studies have been published, but no randomized trials have been conducted. Central venous oxygen saturation (ScvO₂) reflects the balance between oxygen delivery and consumption; its normal physiological range is 70-75%, and a decrease indicates inadequate oxygen delivery and oxygen supply/demand imbalance. Thus, it may serve as a potential physiological trigger for clinicians in personalized transfusion management of hemodynamically stable intensive care patients.

Therefore our aim is to examine the efficacy and safety of an ScvO₂-guided transfusion trigger compared with clinician decision-based transfusion in critically ill patients.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient in medical/surgical/trauma ICU
  • Hemoglobin level between 7g/dl and 9g/dl
  • Written informed consent by patient or next of kin
  • Hemodynamically stable:
  • CRT normal
  • Serum lactate <2 mmol/l
  • MAP >65 mmHg
  • noradrenalin < 0,2 mcg/kg/min and no increase in 6 hours
  • No new ischemic change on ECG
  • Monitored with CVC, arterial catheter, hourly urine output
  • Respiratorily stable
  • No support or
  • Nasal canula/face mask O2 supplementation or
  • NIV or
  • Invasive mechanical ventillation: PC/VC/PS, PEEP< 15 cmH2O FiO2 < 50% and no increase in 6 hours
  • PiCCO or expert ECHO available within 48hours

Exclusion criteria

  • ScvO2>80%
  • Acid-base imbalance (pH<7.3 or pH>7.5)
  • Chronic kidney disease (KDIGO Stage 3-4-5)
  • Acute heart failure (ESC 2021 definition)
  • Pregnancy
  • Active bleeding
  • Neurotrauma requiring intracranial pressure monitoring
  • Morbid obesity BMI >40
  • Horowitz Quotient (paO2/FiO2) < 200
  • Acute and chronic liver failure (Child-Pugh B,C)
  • Fever

Treatment and study plan

Measurement of central venous saturation

Diagnostic Test

After randomisation central venous saturation will be measured. If the central venous saturation is below 70%, 1 unit of red blood cells will be transfused. The central venous saturation will be measured post transfusion, and if it is still below 70%, further 1 unit of RBCs will be transfused. Measurements and transfusions continue until ScvO2 reaches 70% or hemoglobin level increases above 9g/dl.

If ScvO2 is above 70%, no transfusion will be administered. ScvO2 will be measured again between 4-12 hours after the initial measurement. If it is still above 70%, no transfusion will be administered, and no further measurement will be performed on the given day.

Primary outcomes

  1. Number of units of red blood cells transfused per patient

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

Secondary outcomes

  1. Change in central venous saturation (ScvO2) posttransfusion

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

Other outcomes

  1. Length of vasopressor requirement

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

  2. Length of meachanical ventilation

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

  3. Incidence of end-organ failure

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

    Newly developed end-organ dysfunction and failure i.e: bowel ischaemia, acute kindney injury, stroke, AMI

  4. Incidence of infective complications

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

    Incidence of VAP, CLABSI, UTI, wound infection

  5. Length of intensive care unit stay

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

  6. Length of hospital stay

    Time frame: From enrollment to the discharge from the hospital or date of death at the hospital, whichever came first, assessed up to 12 months

  7. Change in CO2-gap post transfusion

    Time frame: From enrollment to the discharge from the intensive care unit or date of death on the intensive care unit, whichever came first, assessed up to 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Nikolett Kiss, Dr

CONTACT

[email protected]

+36204866809

Zsolt Molnar, Professor

CONTACT

[email protected]

+36303026668

Sponsors and collaborators

Lead sponsor

Semmelweis University

Other

Registry information

Official study title

ScvO2-Centered Optimisation of RED Blood Cell Transfusions (SCORED) - Protocol for a Multicenter, Randomised, Controlled Clinical Trial to Compare the Central Venous Saturation (ScvO2) Guided Transfusion Trigger Versus Transfusion Based on Clinician's Decision in the Critically Ill

Acronym: SCORED

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Apr 3, 2026
Registry last updated
Apr 3, 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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