ScvO2-Centered Optimisation of RED Blood Cell Transfusions (SCORED)

March 28, 2026 updated by: Dr. Kiss Nikolett, Semmelweis University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary, 1082
        • Semmelweis University, Department of Intensive Therapy
        • Contact:
      • Budapest, Hungary, 1134
        • North-Pest Central Hospital- Hungarian Defense Forces Medical Center, Department of Anaesthesiology and Intensive Therapy
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Central venous saturation guided transfusion
Transfusion will be ordered and administered if ScvO2 is below 70%
Diagnostic test: Measurement of central venous saturation

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.
No Intervention: Clinician's decision (without ScvO2)
Transfusion will be ordered and administered based on the treating physician's judgment without the knowledge of ScvO2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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 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
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 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
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
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
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
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
From enrollment to the discharge from the hospital or date of death at the hospital, whichever came first, assessed up to 12 months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semmelweis University

Investigators

  • Study Chair: Marton Papp, Dr, Semmelweis University
  • Study Chair: Caner Turan, Dr, Semmelweis University
  • Study Chair: Dilan Mark Karim, Dr, Semmelweis University
  • Study Chair: Laszlo Zubek, Dr, Semmelweis University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 9, 2026

First Submitted That Met QC Criteria

March 28, 2026

First Posted (Actual)

April 3, 2026

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

March 28, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NNGYK/12276-2/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data underlying the results reported in this study will be made available after de-identification. The data will include demographic characteristics, baseline measures, outcomes, and relevant study variables necessary to reproduce the findings.

IPD Sharing Access Criteria

Data will be shared with qualified researchers who provide a methodologically sound proposal. Access will be granted following review and approval by the study institution, and after signing a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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