Clinical trial NCT04506125: Liberal Versus Restrictive Transfusion Threshold in Oncologic surgerY
Official title: Liberal Versus Restrictive Transfusion Threshold in High-risk Oncologic surgerY: a Multicenter, Randomized, Controlled, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oncologic Complications
Anemia
Keywords: Transfusion
Pilot study
critically ill patients
oncologic surgery
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot, multicentre, randomized, controlled, single-blind, pilot study comparing two strategies for transfusion of red blood cell concentrates
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Methodology of the pilot study
timeFrame: up to 30 days
Secondary outcomes:
measure: Epidemiological data of the pilot study
timeFrame: up to 90 days
measure: Epidemiological data of the pilot study
timeFrame: up to 90 days
measure: Epidemiological data of the pilot study
timeFrame: up to 90 days
measure: Epidemiological data of the pilot study
timeFrame: up to 90 days
measure: Epidemiological data of the pilot study
timeFrame: up to 90 days
measure: Epidemiological data of the pilot study
timeFrame: up to 90 days
measure: Adverse Reaction Monitoring
timeFrame: up to 30 days
measure: Evaluation of the functional status
timeFrame: up to 30 days
measure: Evaluation of the functional status after surgery ans anesthesia
timeFrame: up to 30 days
measure: Monitoring of the quality of the study's execution
timeFrame: up to 30 days
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
citation: 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.