Liberal Versus Restrictive Transfusion Threshold in Oncologic surgerY

NCT04506125 | Completed DMC

• 1 other identifier: 29BRC20.0086
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Oncologic Complications; Anemia

Keywords

Transfusion; Pilot study; critically ill patients; oncologic surgery

Outcome Measures

Primary Outcomes (1)

• 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

  up to 30 days

Secondary Outcomes (10)

• Epidemiological data of the pilot study

  up to 90 days

• Epidemiological data of the pilot study

  up to 90 days

• Epidemiological data of the pilot study

  up to 90 days

• Epidemiological data of the pilot study

  up to 90 days

• Epidemiological data of the pilot study

  up to 90 days

Study Arms (2)

Liberal Group

EXPERIMENTAL

transfusion of an erythrocyte concentrate in case of haemoglobin below 9.5 g/dL

Other: Haemoglobin 9.5 g/dL

Restrictive group

ACTIVE COMPARATOR

transfusion of an erythrocyte concentrate in case of haemoglobin below 7.5 g/dL

Other: Haemoglobine 7.5g/dL

Interventions

Haemoglobin 9.5 g/dL OTHER

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

Liberal Group

Haemoglobine 7.5g/dL OTHER

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

Restrictive group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (2)

CHU d'Angers

Angers, 49933, France

Location

CHRU de Brest

Brest, 29609, France

Location

Related Publications (2)

• 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.

  PMID: 41114449 DERIVED

• Carson 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.

  PMID: 34932836 DERIVED

MeSH Terms

Conditions

Anemia

Interventions

Hemoglobins

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot, multicentre, randomized, controlled, single-blind, pilot study comparing two strategies for transfusion of red blood cell concentrates

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 10, 2020
• Study Start: March 18, 2021
• Primary Completion: August 29, 2022
• Study Completion: August 29, 2022
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning two years and ending fifteen years following the final study report completion
• 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

Locations

FR (2)