AutoTransfusion Versus TRAnsfusion in Cancer Surgery

Completed

• Conditions: Hemorrhage; Transfusion; Cancer Surgery
• Interventions: Device: Transfusion

• Registration Number: NCT05452538
• Lead Sponsor: Centre Leon Berard

Brief 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-07-06
• Study First Submitted QC: 2022-07-06
• Study First Posted: 2022-07-11
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5808

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
cancer surgery	Transfusion	all adult patients operated at the Léon Bérard Centre for cancer surgery (excluding endoscopy, interventional radiology, brachytherapy, vascular access)

Primary Outcome Measures

Name	Time	Method
number of annual uses of the intraoperative blood recovery system	Up to 1 year	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

Secondary Outcome Measures

Name	Time	Method
annual cost for the Centre Léon Bérard of the transfusion strategy.	Up to 1 year	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)

Trial Locations

Locations (1)

Centre Léon Bérard; 🇫🇷 Lyon, Rhône, France