Liberal Versus Restrictive Transfusion Threshold in Oncologic surgerY (LIBERTY1)

July 28, 2023 updated by: University Hospital, Brest

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.

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 Overview

Study Type

Interventional

Enrollment (Actual)

30

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

      • Angers, France, 49933
        • CHU d'Angers
      • Brest, France, 29609
        • CHRU de Brest

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
    • 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

Exclusion Criteria:

  • - 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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liberal Group
transfusion of an erythrocyte concentrate in case of haemoglobin below 9.5 g/dL
transfusion of red blood cell concentrate if the haemoglobin level is less than 9,5 g/dL
Active Comparator: Restrictive group
transfusion of an erythrocyte concentrate in case of haemoglobin below 7.5 g/dL
transfusion of red blood cell concentrate if the haemoglobin level is less than 7,5 g/dL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
up to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological data of the pilot study
Time Frame: up to 90 days
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
up to 90 days
Epidemiological data of the pilot study
Time Frame: up to 90 days
Percentage of eligible patients included in the study will be assessed
up to 90 days
Epidemiological data of the pilot study
Time Frame: up to 90 days
Delay between surgery and randomization will be assessed
up to 90 days
Epidemiological data of the pilot study
Time Frame: up to 90 days
Percentage of protocol violations in each group will be assessed
up to 90 days
Epidemiological data of the pilot study
Time Frame: up to 90 days
Average number of erythrocyte concentrates delivered to each group intraoperatively, in intensive care and during hospitalization will be assessed
up to 90 days
Epidemiological data of the pilot study
Time Frame: up to 90 days
Post-operative complications, occurring between surgery and the 30th day after surgery or before discharge from hospital will be assessed
up to 90 days
Adverse Reaction Monitoring
Time Frame: up to 30 days
To compare the occurrence of transfusion-related adverse events in each group
up to 30 days
Evaluation of the functional status
Time Frame: up to 30 days

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.

up to 30 days
Evaluation of the functional status after surgery ans anesthesia
Time Frame: up to 30 days

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

up to 30 days
Monitoring of the quality of the study's execution
Time Frame: up to 30 days
Compare the percentage of protocol violations in the 2 groups
up to 30 days

Collaborators and Investigators

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

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.

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 (Actual)

March 18, 2021

Primary Completion (Actual)

August 29, 2022

Study Completion (Actual)

August 29, 2022

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 28, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data that underlie results in a publication

IPD Sharing Time Frame

Data will be available beginning two years and ending fifteen years following the final study report completion

IPD Sharing Access Criteria

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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.

Clinical Trials on Anemia

Clinical Trials on Haemoglobin 9.5 g/dL

Subscribe