AnaemiaSCOREDNCT07509203
ScvO2-Centered Optimisation of RED Blood Cell Transfusions
A study testing Measurement of central venous saturation in people with Anaemia, run by Semmelweis University at 2 sites in Hungary.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anaemia
- What is being tested?
- Measurement of central venous saturation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 2 sitesHungary
- Study dates
- 15 Apr 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Neurotrauma requiring intracranial pressure monitoring
- Morbid obesity BMI >40
- Horowitz Quotient (paO2/FiO2) < 200
- Acute and chronic liver failure (Child-Pugh B,C)
- Fever
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites
Semmelweis University, Department of Intensive Therapy
Budapest, 1082
Nikolett Kiss, Dr, +36204866809, kiss.nikolett@semmelweis.hu
North-Pest Central Hospital- Hungarian Defense Forces Medical Center, Department of Anaesthesiology and Intensive Therapy
Budapest, 1134
Peter Adam, Dr, +36302734033, peter.adam@epc-honvedkorhaz.hu
About this study
Official 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
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).
Read the 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.
- Conditions
- Anaemia
- Being tested
- Measurement of central venous saturation
- Keywords
- central venous saturation, transfusion, critically ill, ICU, red blood cell
- Medical subject headings
- Anemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of central venous saturationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Central venous saturation guided transfusion | Experimental | Transfusion will be ordered and administered if ScvO2 is below 70% Receives: Diagnostic Test: Measurement of central venous saturation |
| Clinician's decision (without ScvO2) | No intervention | Transfusion will be ordered and administered based on the treating physician's judgment without the knowledge of ScvO2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of units of red blood cells transfused per patient
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start15 Apr 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnaemiaStudies of the same condition, open and under way.
- More trials run by Semmelweis UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Semmelweis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kiss Nikolett, Semmelweis University
- Investigators
- Marton Papp, Dr, Study chair, Semmelweis UniversityCaner Turan, Dr, Study chair, Semmelweis UniversityDilan Mark Karim, Dr, Study chair, Semmelweis UniversityLaszlo Zubek, Dr, Study chair, Semmelweis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07509203
- Sponsor's protocol ID
- NNGYK/12276-2/2026
- Acronym
- SCORED
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Vallet B, Adamczyk S, Barreau O, Lebuffe G. Physiologic transfusion triggers. Best Pract Res Clin Anaesthesiol. 2007 Jun;21(2):173-81. doi: 10.1016/j.bpa.2007.02.003.
PubMed 17650770Lu K, Huang Z, Liang S, Pan F, Zhang C, Wei J, Wei H, Wang Y, Liao R, Huang A, Huang Y. A physiology-based trigger score to guide perioperative transfusion of allogeneic red blood cells: A multicentre randomised controlled trial. Transfus Med. 2022 Oct;32(5):375-382. doi: 10.1111/tme.12883. Epub 2022 May 24.
PubMed 35610743Carson JL, Stanworth SJ, Guyatt G, Valentine S, Dennis J, Bakhtary S, Cohn CS, Dubon A, Grossman BJ, Gupta GK, Hess AS, Jacobson JL, Kaplan LJ, Lin Y, Metcalf RA, Murphy CH, Pavenski K, Prochaska MT, Raval JS, Salazar E, Saifee NH, Tobian AAR, So-Osman C, Waters J, Wood EM, Zantek ND, Pagano MB. Red Blood Cell Transfusion: 2023 AABB International Guidelines. JAMA. 2023 Nov 21;330(19):1892-1902. doi: 10.1001/jama.2023.12914.
PubMed 37824153Raasveld SJ, de Bruin S, Reuland MC, van den Oord C, Schenk J, Aubron C, Bakker J, Cecconi M, Feldheiser A, Meier J, Muller MCA, Scheeren TWL, McQuilten Z, Flint A, Hamid T, Piagnerelli M, Tomic Mahecic T, Benes J, Russell L, Aguirre-Bermeo H, Triantafyllopoulou K, Chantziara V, Gurjar M, Myatra SN, Pota V, Elhadi M, Gawda R, Mourisco M, Lance M, Neskovic V, Podbregar M, Llau JV, Quintana-Diaz M, Cronhjort M, Pfortmueller CA, Yapici N, Nielsen ND, Shah A, de Grooth HJ, Vlaar APJ; InPUT Study Group. Red Blood Cell Transfusion in the Intensive Care Unit. JAMA. 2023 Nov 21;330(19):1852-1861. doi: 10.1001/jama.2023.20737.
PubMed 37824112
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07509203
- Acronym / sponsor ID
- SCORED / NNGYK/12276-2/2026
- Conditions
- Anaemia
- Keywords
- central venous saturation, transfusion, critically ill, ICU, red blood cell
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Semmelweis UniversityUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 3 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central venous saturation guided transfusion | Experimental | Diagnostic Test: Measurement of central venous saturationTransfusion will be ordered and administered if ScvO2 is below 70% |
| Clinician's decision (without ScvO2) | No intervention | –Transfusion will be ordered and administered based on the treating physician's judgment without the knowledge of ScvO2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- Monitored with CVC, arterial catheter, hourly urine output
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of central venous saturationAfter 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. | Diagnostic test | Central venous saturation guided transfusion |
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Background: PubMed 17650770Vallet B, Adamczyk S, Barreau O, Lebuffe G. Physiologic transfusion triggers. Best Pract Res Clin Anaesthesiol. 2007 Jun;21(2):173-81. doi: 10.1016/j.bpa.2007.02.003.
- Background: PubMed 35610743Lu K, Huang Z, Liang S, Pan F, Zhang C, Wei J, Wei H, Wang Y, Liao R, Huang A, Huang Y. A physiology-based trigger score to guide perioperative transfusion of allogeneic red blood cells: A multicentre randomised controlled trial. Transfus Med. 2022 Oct;32(5):375-382. doi: 10.1111/tme.12883. Epub 2022 May 24.
- Background: PubMed 37824153Carson JL, Stanworth SJ, Guyatt G, Valentine S, Dennis J, Bakhtary S, Cohn CS, Dubon A, Grossman BJ, Gupta GK, Hess AS, Jacobson JL, Kaplan LJ, Lin Y, Metcalf RA, Murphy CH, Pavenski K, Prochaska MT, Raval JS, Salazar E, Saifee NH, Tobian AAR, So-Osman C, Waters J, Wood EM, Zantek ND, Pagano MB. Red Blood Cell Transfusion: 2023 AABB International Guidelines. JAMA. 2023 Nov 21;330(19):1892-1902. doi: 10.1001/jama.2023.12914.
- Background: PubMed 37824112Raasveld SJ, de Bruin S, Reuland MC, van den Oord C, Schenk J, Aubron C, Bakker J, Cecconi M, Feldheiser A, Meier J, Muller MCA, Scheeren TWL, McQuilten Z, Flint A, Hamid T, Piagnerelli M, Tomic Mahecic T, Benes J, Russell L, Aguirre-Bermeo H, Triantafyllopoulou K, Chantziara V, Gurjar M, Myatra SN, Pota V, Elhadi M, Gawda R, Mourisco M, Lance M, Neskovic V, Podbregar M, Llau JV, Quintana-Diaz M, Cronhjort M, Pfortmueller CA, Yapici N, Nielsen ND, Shah A, de Grooth HJ, Vlaar APJ; InPUT Study Group. Red Blood Cell Transfusion in the Intensive Care Unit. JAMA. 2023 Nov 21;330(19):1852-1861. doi: 10.1001/jama.2023.20737.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marton Papp, Dr study chair
Semmelweis University
Caner Turan, Dr study chair
Semmelweis University
Dilan Mark Karim, Dr study chair
Semmelweis University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of central venous saturation in people with Anaemia, run by Semmelweis University at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolett Kiss, Dr (+36204866809, kiss.nikolett@semmelweis.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07509203, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.