NCT05452538

AutoTransfusion Versus TRAnsfusion in Cancer Surgery

Autotransfusion Versus Transfusion in Cancer Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,808 (actual)
• Sponsor: Centre Leon Berard · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Hemorrhage
• Cancer Surgery
• Transfusion

Interventions

Type	Name	Description
DEVICE	Transfusion	Data from patients who were transfused at the Centre Léon Bérard from the day of surgery to the 10th postoperative day will be analyzed.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-07-11
• Last updated: 2024-02-26

Locations

1 site across 1 country: France