Transfusion-dependent AnemiaPhase 3LIBERALNCT03369210
Liberal Transfusion Strategy in Elderly Patients
A Phase 3 study testing red blood cell transfusion trigger in people with Transfusion-dependent Anemia and Surgery, run by Johann Wolfgang Goethe University Hospital at 17 sites in Germany.
Trial summary
In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Transfusion-dependent Anemia, Surgery, Anemia
- What is being tested?
- red blood cell transfusion trigger
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,456 participants
- Where
- 17 sitesGermany
- Study dates
- 9 Jan 2018to 30 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered
- Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery
Who cannot join
- preoperative Hb level ≤ 9 g/dl
- chronic kidney disease requiring dialysis
- suspected lack of compliance with follow-up procedures
- participation in other interventional trials
- expected death within 3 months
- inability to provide informed consent with absence of a legally authorised representative/ legal guardian
Show all 10Show fewer
- temporary inability to provide informed consent
- previous participation in our trial
- patients who are prevented from having blood and blood products according to a system of beliefs (e.g. Jehovah's Witnesses)
- preoperative autologous blood donation.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Germany17 sites
University Hospital RWTH
Aachen
University Hospital Augsburg
Augsburg
Berlin Charite CCM
Berlin
Charite Berlin CBF
Berlin
University Hospital Bonn
Bonn
Klinikum Dortmund
Dortmund
University Hospital Frankfurt
Frankfurt
University Hospital Giessen
Giessen
University Hospital Greifswald
Greifswald
University Hospital Hamburg
Hamburg
University Hospital Jena
Jena
University Hospital Schleswig-Holstein
Kiel
University Hospital Mainz
Mainz
St. Franziskus Hospital Münster
Münster
University Hospital Münster
Münster
University Hospital Regensburg
Regensburg
University Hospital Würzburg
Würzburg, 97080
About this study
Official title: Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
In this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.
- Conditions
- Transfusion-dependent Anemia, Surgery, Anemia
- Being tested
- red blood cell transfusion trigger
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
red blood cell transfusion triggerDrug
patients receive a RBC unit with different target ranges for the post-transfusion Hb levels
| Study group | Role | What they receive |
|---|---|---|
| Liberal | Experimental | Liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)). Receives: Drug: red blood cell transfusion trigger |
| Restrictive | Active comparator | Restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Receives: Drug: red blood cell transfusion trigger |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of a composite outcome
Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level ≥ 3 times within a time window of 7 days or initiation of renal replacement therapy.
- Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography).
VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery.
Measured: 90 days
Secondary outcomes (10)
Proportion of patients receiving red blood cell transfusion
Measured: hospital discharge (an anticipated average of 10 days)
Number of red blood cell units transfused
Measured: hospital discharge (an anticipated average of 10 days)
Total length of stay in the intensive care unit
Measured: hospital discharge (an anticipated average of 10 days)
Total length of stay in hospital
Measured: hospital discharge (an anticipated average of 10 days)
Number of participants with acute kidney injury stage I-II
The occurrence of acute kidney injury (stage I or II) defined according to the Kidney Disease Improving Global Outcomes criteria (stage I: increase of plasma creatinine level ≥ 1.5-1.9 times baseline or ≥ 0.3mg/dl within 48 hours; stage II: increase of plasma creatinine level ≥ 2-2.9 times baseline within a time window of 7 days) during the initial hospital stay
Measured: hospital discharge (an anticipated average of 10 days)
Time to infection
Time to (first) infection (infection requiring therapeutic intravenous antibiotic treatment (pneumonia, wound infection, sepsis, central line associated blood stream infection)) during the initial hospital stay or leading to hospital re-admission
Measured: 90 days
Time to re-hospitalisation
Time to (first) re-hospitalisation
Measured: 90 days
functional status (Barthel index)
Functional status (assessed by Barthel Index)
Measured: 90 days
Health-related quality of life
Health-related quality of life (assessed by EuroQoL EQ-5D and 12-item World Health Organisation Disability Assessment Schedule WHODAS 2.043) by telephone questionnaire)
Measured: 90 days
Occurrence of any individual component of the composite
composite components (all-cause mortality, acute myocardial infarction, acute stroke, acute kidney injury stage III, acute mesenteric ischaemia, and/or acute peripheral vascular ischaemia)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start9 Jan 2018
- Primary completion30 Jun 2025
- Study completion30 Apr 2026
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 Transfusion-dependent AnemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuerzburg University Hospital
- Responsible party
- Principal investigator, Dr. Patrick Meybohm, M.D., Wuerzburg University Hospital
- Investigators
- Patrick Meybohm, MD, Principal investigator, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03369210
- Sponsor's protocol ID
- 139/17F
- Acronym
- LIBERAL
- Status last verified
- Jul 2026
- First submitted
- 27 Nov 2017
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meybohm P, Lindau S, Treskatsch S, Francis R, Spies C, Velten M, Wittmann M, Gueresir E, Stoppe C, Kowark A, Coburn M, Selleng S, Baschin M, Jenichen G, Meersch M, Ermert T, Zarbock A, Kranke P, Kredel M, Helf A, Laufenberg-Feldmann R, Ferner M, Wittenmeier E, Gurtler KH, Kienbaum P, de Abreu MG, Sander M, Bauer M, Seyfried T, Gruenewald M, Choorapoikayil S, Mueller MM, Seifried E, Brosteanu O, Bogatsch H, Hasenclever D, Zacharowski K; LIBERAL Collaboration Group. Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial. Trials. 2019 Feb 4;20(1):101. doi: 10.1186/s13063-019-3200-3.
PubMed 30717805Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
PubMed 41114449Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
PubMed 38780066Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
PubMed 34932836
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Transfusion Strategy to Prevent Mortality and Anaemia-associated, Ischaemic Events in Elderly Non-cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT03369210
- Acronym / sponsor ID
- LIBERAL / 139/17F
- Conditions
- Transfusion-dependent Anemia, Surgery, Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,456 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Collaborators
- Wuerzburg University Hospital
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 11 Dec 2017 (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 this prospective, multicentre, open, randomised, controlled clinical trial elderly patients (≥ 70 years) undergoing intermediate- or high-risk non-cardiac surgery will be randomised either to a liberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)) or restrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). Primary efficacy endpoint: is a composite of death from any cause and anaemia-associated, ischaemic events (defined as acute myocardial infarction, acute ischaemic stroke, acute kidney injury stage III, acute mesenteric ischaemia, acute peripheral vascular ischaemia) within 90 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal | Experimental | Drug: red blood cell transfusion triggerLiberal group (patients receive a RBC unit each time Hb falls ≤ 9 g/dl (≤ 5.6mmol/l) with a target range for the post-transfusion Hb level of 9-10.5 g/dl (5.6-6.5 mmol/l)). |
| Restrictive | Active comparator | Drug: red blood cell transfusion triggerRestrictive group (patients receive a single RBC unit each time Hb falls ≤ 7.5 g/dl (≤ 4.7 mmol/l) with a target range for the post-transfusion Hb level of 7.5-9 g/dl (4.7-5.6 mmol/l). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients ≥ 70 years of age scheduled for intermediate- or high-risk non-cardiac surgery will be registered
- Registered patients will be randomised only if they indeed develop severe anaemia (if Hb level falls ≤ 9 g/dl) during surgery (=day 0) or day 1, 2, or 3 after surgery
Key exclusion criteria (10 listed)
- preoperative Hb level ≤ 9 g/dl
- chronic kidney disease requiring dialysis
- suspected lack of compliance with follow-up procedures
- participation in other interventional trials
- expected death within 3 months
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 |
|---|---|---|
| red blood cell transfusion triggerpatients receive a RBC unit with different target ranges for the post-transfusion Hb levels | Drug | Liberal, Restrictive |
Primary outcome
Occurrence of a composite outcome
Time frame: 90 days
Composite of death and anaemia-associated events I. All-cause mortality defined as death from any cause. II. Acute myocardial infarction confirmed by a cardiologist III. Acute ischaemic stroke confirmed by a neurologist IV. Acute kidney injury (stage III) defined according to the Kidney Disease Improving Global Outcomes criteria: Increase of plasma creatinine level ≥ 3 times within a time window of 7 days or initiation of renal replacement therapy. V. Acute mesenteric ischaemia defined as ischaemia confirmed by intervention (abdominal surgery or mesenteric angiography). VI. Acute peripheral vascular ischaemia defined as a new non-thrombotic compromised circulation in a limb confirmed by angiography and/or leading to surgery.
10 secondary outcomes
Proportion of patients receiving red blood cell transfusion
Time frame: hospital discharge (an anticipated average of 10 days)
Number of red blood cell units transfused
Time frame: hospital discharge (an anticipated average of 10 days)
Total length of stay in the intensive care unit
Time frame: hospital discharge (an anticipated average of 10 days)
Total length of stay in hospital
Time frame: hospital discharge (an anticipated average of 10 days)
Number of participants with acute kidney injury stage I-II
Time frame: hospital discharge (an anticipated average of 10 days)
Time to infection
Time frame: 90 days
Time to re-hospitalisation
Time frame: 90 days
functional status (Barthel index)
Time frame: 90 days
Health-related quality of life
Time frame: 90 days
Occurrence of any individual component of the composite
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Results publication: PubMed 30717805Meybohm P, Lindau S, Treskatsch S, Francis R, Spies C, Velten M, Wittmann M, Gueresir E, Stoppe C, Kowark A, Coburn M, Selleng S, Baschin M, Jenichen G, Meersch M, Ermert T, Zarbock A, Kranke P, Kredel M, Helf A, Laufenberg-Feldmann R, Ferner M, Wittenmeier E, Gurtler KH, Kienbaum P, de Abreu MG, Sander M, Bauer M, Seyfried T, Gruenewald M, Choorapoikayil S, Mueller MM, Seifried E, Brosteanu O, Bogatsch H, Hasenclever D, Zacharowski K; LIBERAL Collaboration Group. Liberal transfusion strategy to prevent mortality and anaemia-associated, ischaemic events in elderly non-cardiac surgical patients - the study design of the LIBERAL-Trial. Trials. 2019 Feb 4;20(1):101. doi: 10.1186/s13063-019-3200-3.
- Derived from this study: PubMed 41114449Carson JL, Stanworth SJ, Dennis JA, Fergusson DA, Pagano MB, Roubinian NH, Turgeon AF, Valentine S, Trivella M, Doree C, Hebert PC. Transfusion thresholds and other strategies for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2025 Oct 20;10(10):CD002042. doi: 10.1002/14651858.CD002042.pub6.
- Derived from this study: PubMed 38780066Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.
- Derived from this study: PubMed 34932836Carson JL, Stanworth SJ, Dennis JA, Trivella M, Roubinian N, Fergusson DA, Triulzi D, Doree C, Hebert PC. Transfusion thresholds for guiding red blood cell transfusion. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002042. doi: 10.1002/14651858.CD002042.pub5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Patrick Meybohm, MD principal investigator
Wuerzburg University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing red blood cell transfusion trigger in people with Transfusion-dependent Anemia and Surgery, run by Johann Wolfgang Goethe University Hospital at 17 sites in Germany.
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 10 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: finished, as of the sponsor's last update on 21 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 17 sites in Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a composite outcome (time frame: 90 days). 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 NCT03369210, 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 21 Jul 2026.