AutoTransfusion Versus TRAnsfusion in Cancer Surgery

Study Overview
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Brief Summary
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Acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate. The only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects. Nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions.

Detailed Description
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Acute bleeding is one of the most frequent intraoperative adverse events and is burdened with a significant morbidity and mortality rate. The only available treatment for severe exsanguination is homologous transfusion, but this is itself complicated by side effects (immunosuppression, increased rate of carcinological recurrence...). Nevertheless, systems exist allowing the recovery, treatment and intraoperative reinjection of lost blood, thus limiting transfusions. The aim of this work is to collect and analyze the estimated bleeding and the hemoglobin level of patients who underwent an intermediate or major operation in the general block of the Centre Léon Bérard in 2021 and who were transfused within 10 days of this operation. In the first stage of data analysis, the investigators will collect data related to perioperative transfusion currently performed at the Centre Léon Bérard (year 2021). Then, a pharmacoeconomic analysis will be carried out with an evaluation of the cell salvage technique by mini-HTA (Health Technology Assessment) type (clinical benefit, patient safety, target population, robustness of clinical evidence, budgetary impact, amount of investment, impact in terms of human resources (training), efficiency) with the objective of helping the Centre Léon Bérard management to make a decision.

Official Title
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Autotransfusion Versus Transfusion in Cancer Surgery

Conditions
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Hemorrhage, Cancer Surgery, Transfusion

Intervention / Treatment
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* Device: Transfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Surgery at the Centre Léon Bérard in 2021 transfusion from the day of surgery to the 10th postoperative day Exclusion Criteria: Digestive endoscopy, interventional radiology, brachytherapy Vascular access only Patient refusal

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cancer surgery<br>all adult patients operated at the Léon Bérard Centre for cancer surgery (excluding endoscopy, interventional radiology, brachytherapy, vascular access) | Device: Transfusion<br>* Data from patients who were transfused at the Centre Léon Bérard from the day of surgery to the 10th postoperative day will be analyzed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of annual uses of the intraoperative blood recovery system | number of annual uses (at the Centre Léon Bérard in 2021) of the intraoperative blood recovery system in the indications validated by the French High Authority for Health | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| annual cost for the Centre Léon Bérard of the transfusion strategy. | Pharmacoeconomic analysis will be performed with an evaluation of the Cell-Saver mini-Health Technology Assessment technique (clinical benefit, patient safety, target population, robustness of clinical evidence, budgetary impact, investment amount, impact in terms of human resources (training), efficiency) | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intraoperative blood salvage, cancer surgery, pharmacoeconomic analysis, transfusion