Liberal Versus Restrictive Transfusion Threshold in Oncologic surgerY

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-18

Study Completion Date

2022-08-29

Brief Summary

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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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Detailed Description

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Conditions

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Oncologic Complications Anemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Liberal Group

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

Group Type EXPERIMENTAL

Haemoglobin 9.5 g/dL

Intervention Type OTHER

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

Restrictive group

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

Group Type ACTIVE_COMPARATOR

Haemoglobine 7.5g/dL

Intervention Type OTHER

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

Interventions

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Haemoglobin 9.5 g/dL

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

Intervention Type OTHER

Haemoglobine 7.5g/dL

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No