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NCT Number: NCT04506125

Liberal Versus Restrictive Transfusion Threshold in Oncologic surgerY

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU d'Angers, Angers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haemoglobin 9.5 g/dL

Other

transfusion of red blood cell concentrate if the haemoglobin level is less than 9,5 g/dL

Haemoglobine 7.5g/dL

Other

transfusion of red blood cell concentrate if the haemoglobin level is less than 7,5 g/dL

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. Epidemiological data of the pilot study

    Time frame: up to 90 days

    Percentage of eligible patients included in the study will be assessed

  3. Epidemiological data of the pilot study

    Time frame: up to 90 days

    Delay between surgery and randomization will be assessed

  4. Epidemiological data of the pilot study

    Time frame: up to 90 days

    Percentage of protocol violations in each group will be assessed

  5. 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

  6. 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

  7. Adverse Reaction Monitoring

    Time frame: up to 30 days

    To compare the occurrence of transfusion-related adverse events in each group

  8. 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.

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

Liberal Versus Restrictive Transfusion Threshold in High-risk Oncologic surgerY: a Multicenter, Randomized, Controlled, Pilot Study

Acronym: LIBERTY1

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2020
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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