Blood TransfusionOXYTRIPNCT06102590
Oxygen Extraction-guided Transfusion
A study testing Individualized red blood cell transfusion strategy and European guidelines red blood cell transfusion strategy in people with Blood Transfusion, run by Università degli Studi di Ferrara at 4 sites in 2 countries.
Trial summary
In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level < 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Transfusion
- What is being tested?
- Individualized red blood cell transfusion strategy and European guidelines red blood cell transfusion strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 4 Nov 2023to 1 Mar 2027
- 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
- Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis)
- Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).
Who cannot join
- Age < 18 years;
- Pregnancy
- Clinical evidence of acute bleeding
- Diagnosis of haematological malignancy
- Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs
- Acquired or congenital disorders of coagulation
- Patients with ongoing AKI of stage 1 or worse and/or known chronic kidney disease (CKD) of stage G3a or worse, defined as glomerular filtration rate below 60 for a minimum of 3 months
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Italy3 sites, 3 recruiting
- Recruiting
Università di Ferrara
Ferrara, Ferrara, 44121
Alberto Fogagnolo, MD, 0532237231, alberto.fogagnolo@gmail.com
Savino Spadaro, PhD, savinospadaro@gmail.com
- Recruiting
Università di Perugia
Perugia, Italy, 06121
Angelo Giacomucci, 00390755783298, angelo.giacomucci@ospedale.perugia.it
- Recruiting
Anestesia e Rianimazione Cardio-Toraco-Vascolare
Siena
Federico Franchi, 0577 586819., federico.franchi@unisi.it
Belgium1 site, 1 recruiting
- Recruiting
Hospital Erasme
Brussels
Fabio Silvio Taccone, +32 (0)2 555 5587, Fabio.Taccone@ulb.be
About this study
Official title: Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.
In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level < 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients [11]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.
- Conditions
- Blood Transfusion
- Being tested
- Individualized red blood cell transfusion strategy, European guidelines red blood cell transfusion strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized red blood cell transfusion strategyOther
Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%.
European guidelines red blood cell transfusion strategyOther
RBCT according to ESICM guidelines
| Study group | Role | What they receive |
|---|---|---|
| Individualized RBCT | Experimental | Requires daily assessment of hemoglobin (Hb) levels. Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. If O2ER < 30%, transfusion will take place only when Hb falls below 7.0 g/dL. Further O2ER measurements during the day in this group are allowed, and the clinician should not be blinded of the results. To tolerate Hb levels below 7.0 g/dL with O2ER < 30% remains a clinical decision, documented in the CRF. Transfusion with Hb below 6.0 g/dL is mandatory Receives: Other: Individualized red blood cell transfusion strategy |
| Control group | Active comparator | Requires daily assessment of hemoglobin levels. Prescription of RCBT is restricted to patients who present Hb ≤ 7.0 g/dL, despite of O2ER values. Indeed, O2ER calculation takes place at least once daily in this group but does not interfere with clinical decision to prescribe RBCT. A liberal transfusion threshold (i.e. 9.0 g/dL) is still possible in critically ill adults with acute coronary syndromes, as indicated by the European current guidelines Receives: Other: European guidelines red blood cell transfusion strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Kidney Injury (AKI)
Primary outcome will be the incidence of AKI, according to KDIGO latest definitions
Measured: 7-day after study inclusion
Secondary outcomes (8)
90-day mortality
Measured: 90-day after study inclusion
proportion of patients undergoing RBCT, despite adequate/low O2ER
Patients receiving RBCT with O2ER<30%
Measured: 28 days
SOFA score variations
SOFA score at study inclusion-SOFA score at day 5
Measured: 5 days
variations in myocardial-specific troponin
variations in myocardial-specific troponin
Measured: 24 hours after study inclusion
days on vasopressors
number of days on vasopressor therapy
Measured: 28 days
Major Adverse Kidney Events by 90 days (MAKE90)
composite of death, new renal replacement therapy, or persistent renal dysfunction
Measured: 90 days
ICU mortality
ICU mortality
Measured: through study completion, an average of 180 days
In-hospital mortality
In-hospital mortality
Measured: through study completion, an average of 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start4 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood TransfusionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università degli Studi di Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alberto Fogagnolo, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06102590
- Sponsor's protocol ID
- OXYTRIP
- Acronym
- OXYTRIP
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2023
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To be shared under reasonable requests.
Publications
Fogagnolo A, Azzolina D, Taccone FS, Pedarzani E, Pasa G, Marianello D, Valpiani G, Marchesini C, Annoni F, Moureau A, Volta CA, Franchi F, Spadaro S. Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial. BMJ Open. 2024 Nov 12;14(11):e089910. doi: 10.1136/bmjopen-2024-089910.
PubMed 39532348
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygen Extraction-guided Transfusion Strategy in Critically Ill Patients. A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06102590
- Acronym / sponsor ID
- OXYTRIP / OXYTRIP
- Conditions
- Blood Transfusion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Università degli Studi di FerraraUniversity, hospital or other
- Study start
- 4 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 26 Oct 2023 (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.
In critically ill patients, optimized strategies for red blood cells transfusion (RBCT) are still controversial. Most recent guidelines suggest that clinical practice in ICU setting should follow a restrictive approach to RBCT (i.e., hemoglonim level < 7.0 g/dL).In our previous study, oxygen extraction ratio (O2ER) has shown good performance as a marker to identify the correct timing for RBCT, potentially affecting 90-day mortality in non-bleeding, critically ill patients [11]. Moreover, our data suggested that an individualized strategy for RBCT may reduce the incidence of acute kidney injury (AKI), which is possibly related to a better delivery of oxygen and organ perfusion.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized RBCT | Experimental | Other: Individualized red blood cell transfusion strategyRequires daily assessment of hemoglobin (Hb) levels. Prescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. If O2ER < 30%, transfusion will take place only when Hb falls below 7.0 g/dL. Further O2ER measurements during the day in this group are allowed, and the clinician should not be blinded of the results. To tolerate Hb levels below 7.0 g/dL with O2ER < 30% remains a clinical decision, documented in the CRF. Transfusion with Hb below 6.0 g/dL is mandatory |
| Control group | Active comparator | Other: European guidelines red blood cell transfusion strategyRequires daily assessment of hemoglobin levels. Prescription of RCBT is restricted to patients who present Hb ≤ 7.0 g/dL, despite of O2ER values. Indeed, O2ER calculation takes place at least once daily in this group but does not interfere with clinical decision to prescribe RBCT. A liberal transfusion threshold (i.e. 9.0 g/dL) is still possible in critically ill adults with acute coronary syndromes, as indicated by the European current guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hb levels ≤ 9.0 g/dL (as confirmed through a blood test and/or through blood gas analysis)
- Presence of an arterial line and a central venous line (either jugular or subclavian), with confirmed correct position of the catheter tip at the atrio-caval junction (allowing correct estimation of central venous saturation, ScvO2).
Key exclusion criteria (7 listed)
- Age < 18 years;
- Pregnancy
- Clinical evidence of acute bleeding
- Diagnosis of haematological malignancy
- Diagnosis of sickle cell disease, or other diseases exposing the patient to chronic RCBTs
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 |
|---|---|---|
| Individualized red blood cell transfusion strategyPrescription of RCBT is restricted to patients who present Hb ≤ 9.0 g/dL and O2ER ≥ 30%. | Other | Individualized RBCT |
| European guidelines red blood cell transfusion strategyRBCT according to ESICM guidelines | Other | Control group |
Primary outcome
Acute Kidney Injury (AKI)
Time frame: 7-day after study inclusion
Primary outcome will be the incidence of AKI, according to KDIGO latest definitions
8 secondary outcomes
90-day mortality
Time frame: 90-day after study inclusion
proportion of patients undergoing RBCT, despite adequate/low O2ER
Time frame: 28 days
SOFA score variations
Time frame: 5 days
variations in myocardial-specific troponin
Time frame: 24 hours after study inclusion
days on vasopressors
Time frame: 28 days
Major Adverse Kidney Events by 90 days (MAKE90)
Time frame: 90 days
ICU mortality
Time frame: through study completion, an average of 180 days
In-hospital mortality
Time frame: through study completion, an average of 180 days
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 31 Jul 2026.
- Derived from this study: PubMed 39532348Fogagnolo A, Azzolina D, Taccone FS, Pedarzani E, Pasa G, Marianello D, Valpiani G, Marchesini C, Annoni F, Moureau A, Volta CA, Franchi F, Spadaro S. Oxygen extraction-guided transfusion strategy in critically ill patients: study protocol for a randomised, open-labelled, controlled trial. BMJ Open. 2024 Nov 12;14(11):e089910. doi: 10.1136/bmjopen-2024-089910.
- Individual participant dataSharing planned: Yes. To be shared under reasonable requests.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized red blood cell transfusion strategy and European guidelines red blood cell transfusion strategy in people with Blood Transfusion, run by Università degli Studi di Ferrara at 4 sites in 2 countries.
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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy, Belgium. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Kidney Injury (AKI) (time frame: 7-day after study inclusion). 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 NCT06102590, which also lists 1 linked publication.
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 31 Jul 2026.