Oncologic ComplicationsLIBERTY1NCT04506125
Liberal Versus Restrictive Transfusion Threshold in Oncologic surgerY
A study testing Haemoglobin 9.5 g/dL and Haemoglobine 7.5g/dL in people with Oncologic Complications and Anemia, run by University Hospital, Brest at 2 sites in France.
Trial summary
Anemia is common in oncology. Up to three-quarters of cancer patients are exposed to an episode of anemia. In oncology surgery, perioperative bleeding is a major risk factor for anemia. Indeed, 13 to 40% of patients are transfused in perioperative oncologic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oncologic Complications, Anemia
- What is being tested?
- Haemoglobin 9.5 g/dL and Haemoglobine 7.5g/dL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Mar 2021to 29 Aug 2022
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Anticipated or proven admission to immediate postoperative resuscitation after scheduled or emergency oncology surgery, for the removal of a neoplastic lesion among the following surgical procedures:
- Visceral surgery: Hepatectomy, duodenopancreatectomy, gastrectomy, esophagectomy, colectomy
- Urological surgery: Radical prostatectomy, cystectomy, nephrectomy.
- Gynaecological surgery: Ovariectomy, hysterectomy, mastectomy, pelvectomy
- Thoracic surgery: Pneumonectomy, lobectomy
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- ENT Surgery: Total laryngectomy, pharyngectomy, glossectomy
- Spinal surgery: corporectomy wherever it is performed.
- Hemoglobin level < 9.5 g/dl between the day before surgery (D-1) and discharge from resuscitation at no more than 30 days postoperatively
Who cannot join
- - Myocardial infarction and/or unstable angina in the 4 weeks prior to surgery
- Refusal to participate in the study
- Minor patient (age < 18 years)
- Refusal to transfuse red blood cell concentrates (Jehovah's Witness)
- Pregnant or breastfeeding women
- Patients under guardianship or curatorship
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Liberal Versus Restrictive Transfusion Threshold in High-risk Oncologic surgerY: a Multicenter, Randomized, Controlled, Pilot Study
Anemia is common in oncology. Up to three-quarters of cancer patients are exposed to an episode of anemia. In oncology surgery, perioperative bleeding is a major risk factor for anemia. Indeed, 13 to 40% of patients are transfused in perioperative oncologic surgery.
There is an association between anemia and prognosis. Several epidemiological studies have shown a strong association between anemia and altered quality of life. In oncology cohort studies, anemic patients had a significantly lower quality of life compared to patients without anemia. In non-cardiac surgery, preoperative anaemia was significantly associated with post-operative mortality. There is also an association between preoperative anaemia and the occurrence of post-operative complications. In oncology surgery, cohort studies conducted in colorectal surgery and neurosurgery found an association between the occurrence of perioperative anemia and post-operative morbidity and mortality.
Read more
The optimal transfusion strategy is unknown in oncology patients. Several multicentre randomised trials, conducted in resuscitation patients or in perioperative settings, have compared a "restrictive" to a "liberal" transfusion strategy. These studies did not show a superiority of one strategy over another on patient outcomes but a lower exposure to red blood cell concentrates in patients transfused with the restrictive transfusion strategy. Thus, the French High Authority for Health (HAS) has adopted a haemoglobin level of 7 g/dl as the transfusion threshold for any transfusion of red blood cell concentrate carried out in the operating theatre and in intensive care in the absence of special cases such as the presence of acute coronary syndrome. For oncology patients, no recommendation could be made due to the lack of evidence-based literature and the optimal transfusion strategy for these patients remains unknown. Only 2 monocentric trials performed in oncology (critical care and perioperative) suggest a benefit of a liberal strategy (transfusion for a haemoglobin level < 9 g/dl) on the short-term vital prognosis, but these studies suffer from numerous limitations leaving the question unresolved.
Before conducting a large phase III trial, a pilot study is needed to validate the methodology of this multicentre clinical trial and to assess its feasibility.
- Conditions
- Oncologic Complications, Anemia
- Being tested
- Haemoglobin 9.5 g/dL, Haemoglobine 7.5g/dL
- Keywords
- Transfusion, Pilot study, critically ill patients, oncologic surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemoglobin 9.5 g/dLOther
transfusion of red blood cell concentrate if the haemoglobin level is less than 9,5 g/dL
Haemoglobine 7.5g/dLOther
transfusion of red blood cell concentrate if the haemoglobin level is less than 7,5 g/dL
| Study group | Role | What they receive |
|---|---|---|
| Liberal Group | Experimental | transfusion of an erythrocyte concentrate in case of haemoglobin below 9.5 g/dL Receives: Other: Haemoglobin 9.5 g/dL |
| Restrictive group | Active comparator | transfusion of an erythrocyte concentrate in case of haemoglobin below 7.5 g/dL Receives: Other: Haemoglobine 7.5g/dL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methodology of the pilot study
The difference in mean hemoglobin levels during the perioperative period up to 30 days postoperatively between the two groups will be assessed
Measured: up to 30 days
Secondary outcomes (10)
Epidemiological data of the pilot study
The percentage of patients with oncologic surgery admitted to intensive care unit requiring transfusion of red blood cell concentrates eerioperatively among aatients with oncologic surgery admitted to intensive care unit will be assessed
Measured: up to 90 days
Epidemiological data of the pilot study
Percentage of eligible patients included in the study will be assessed
Measured: up to 90 days
Epidemiological data of the pilot study
Delay between surgery and randomization will be assessed
Measured: up to 90 days
Epidemiological data of the pilot study
Percentage of protocol violations in each group will be assessed
Measured: up to 90 days
Epidemiological data of the pilot study
Average number of erythrocyte concentrates delivered to each group intraoperatively, in intensive care and during hospitalization will be assessed
Measured: up to 90 days
Epidemiological data of the pilot study
Post-operative complications, occurring between surgery and the 30th day after surgery or before discharge from hospital will be assessed
Measured: up to 90 days
Adverse Reaction Monitoring
To compare the occurrence of transfusion-related adverse events in each group
Measured: up to 30 days
Evaluation of the functional status
Test functional status assessment at 30 days postoperatively using the World Health Organization Disability Assessment Schedule (WHODAS) questionnaire.
This questionnaire asks about difficulties due to health/mental health conditions. Health conditions include diseases or illnesses, other health problems that may be short or long lasting, injuries, mental or emotional problems, and problems with alcohol or drugs. The patient must think back over the past 30 days and answer the questions thinking about how much difficulty you had doing the following activities.
Measured: up to 30 days
Evaluation of the functional status after surgery ans anesthesia
Test functional status assessment at 30 days postoperatively using the Quality of recovery questionnaire.
The Quality of Recovery-15 (QoR-15) is a psychometrically tested and validated questionnaire.
The QoR-15 was psychometrically evaluated using data collected from patients who responded at all four time intervals.This included: Acceptability and Feasibility; Validity; Reliability; Responsiveness
Measured: up to 30 days
Monitoring of the quality of the study's execution
Compare the percentage of protocol violations in the 2 groups
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start18 Mar 2021
- Primary completion29 Aug 2022
- Study completion29 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Oncologic ComplicationsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot, multicentre, randomized, controlled, single-blind, pilot study comparing two strategies for transfusion of red blood cell concentrates
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506125
- Sponsor's protocol ID
- 29BRC20.0086
- Acronym
- LIBERTY1
- Status last verified
- Jul 2023
- First submitted
- 29 Jul 2020
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Publications
Carson 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 41114449Carson 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 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liberal Versus Restrictive Transfusion Threshold in High-risk Oncologic surgerY: a Multicenter, Randomized, Controlled, Pilot Study
- ClinicalTrials.gov ID
- NCT04506125
- Acronym / sponsor ID
- LIBERTY1 / 29BRC20.0086
- Conditions
- Oncologic Complications, Anemia
- Keywords
- Transfusion, Pilot study, critically ill patients, oncologic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 29 Aug 2022 (actual)
- Study completion
- 29 Aug 2022 (actual)
- First posted
- 10 Aug 2020 (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.
Anemia is common in oncology. Up to three-quarters of cancer patients are exposed to an episode of anemia. In oncology surgery, perioperative bleeding is a major risk factor for anemia. Indeed, 13 to 40% of patients are transfused in perioperative oncologic surgery.
There is an association between anemia and prognosis. Several epidemiological studies have shown a strong association between anemia and altered quality of life. In oncology cohort studies, anemic patients had a significantly lower quality of life compared to patients without anemia. In non-cardiac surgery, preoperative anaemia was significantly associated with post-operative mortality. There is also an association between preoperative anaemia and the occurrence of post-operative complications. In oncology surgery, cohort studies conducted in colorectal surgery and neurosurgery found an association between the occurrence of perioperative anemia and post-operative morbidity and mortality.
The optimal transfusion strategy is unknown in oncology patients. Several multicentre randomised trials, conducted in resuscitation patients or in perioperative settings, have compared a "restrictive" to a "liberal" transfusion strategy. These studies did not show a superiority of one strategy over another on patient outcomes but a lower exposure to red blood cell concentrates in patients transfused with the restrictive transfusion strategy. Thus, the French High Authority for Health (HAS) has adopted a haemoglobin level of 7 g/dl as the transfusion threshold for any transfusion of red blood cell concentrate carried out in the operating theatre and in intensive care in the absence of special cases such as the presence of acute coronary syndrome. For oncology patients, no recommendation could be made due to the lack of evidence-based literature and the optimal transfusion strategy for these patients remains unknown. Only 2 monocentric trials performed in oncology (critical care and perioperative) suggest a benefit of a liberal strategy (transfusion for a haemoglobin level < 9 g/dl) on the short-term vital prognosis, but these studies suffer from numerous limitations leaving the question unresolved.
Before conducting a large phase III trial, a pilot study is needed to validate the methodology of this multicentre clinical trial and to assess its feasibility.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot, multicentre, randomized, controlled, single-blind, pilot study comparing two strategies for transfusion of red blood cell concentrates
| Arm | Type | Receives |
|---|---|---|
| Liberal Group | Experimental | Other: Haemoglobin 9.5 g/dLtransfusion of an erythrocyte concentrate in case of haemoglobin below 9.5 g/dL |
| Restrictive group | Active comparator | Other: Haemoglobine 7.5g/dLtransfusion of an erythrocyte concentrate in case of haemoglobin below 7.5 g/dL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years old
- Anticipated or proven admission to immediate postoperative resuscitation after scheduled or emergency oncology surgery, for the removal of a neoplastic lesion among the following surgical procedures:
- Hemoglobin level < 9.5 g/dl between the day before surgery (D-1) and discharge from resuscitation at no more than 30 days postoperatively
Key exclusion criteria (6 listed)
- - Myocardial infarction and/or unstable angina in the 4 weeks prior to surgery
- Refusal to participate in the study
- Minor patient (age < 18 years)
- Refusal to transfuse red blood cell concentrates (Jehovah's Witness)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Haemoglobin 9.5 g/dLtransfusion of red blood cell concentrate if the haemoglobin level is less than 9,5 g/dL | Other | Liberal Group |
| Haemoglobine 7.5g/dLtransfusion of red blood cell concentrate if the haemoglobin level is less than 7,5 g/dL | Other | Restrictive group |
Primary outcome
Methodology of the pilot study
Time frame: up to 30 days
The difference in mean hemoglobin levels during the perioperative period up to 30 days postoperatively between the two groups will be assessed
10 secondary outcomes
Epidemiological data of the pilot study
Time frame: up to 90 days
Epidemiological data of the pilot study
Time frame: up to 90 days
Epidemiological data of the pilot study
Time frame: up to 90 days
Epidemiological data of the pilot study
Time frame: up to 90 days
Epidemiological data of the pilot study
Time frame: up to 90 days
Epidemiological data of the pilot study
Time frame: up to 90 days
Adverse Reaction Monitoring
Time frame: up to 30 days
Evaluation of the functional status
Time frame: up to 30 days
Evaluation of the functional status after surgery ans anesthesia
Time frame: up to 30 days
Monitoring of the quality of the study's execution
Time frame: up to 30 days
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 1 Aug 2023.
- 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 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.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haemoglobin 9.5 g/dL and Haemoglobine 7.5g/dL in people with Oncologic Complications and Anemia, run by University Hospital, Brest at 2 sites in France.
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 9 inclusion and 6 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 1 Aug 2023. 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 France. 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?
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?
Methodology of the pilot study (time frame: up to 30 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 NCT04506125, which also lists 2 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 1 Aug 2023.