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OpenTrials
Completed

NCT Number: NCT05452538

AutoTransfusion Versus TRAnsfusion in Cancer Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Léon Bérard

Lyon, Rhône, 69008, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transfusion

Device

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

Primary outcomes

  1. number of annual uses of the intraoperative blood recovery system

    Time frame: 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 outcomes

  1. annual cost for the Centre Léon Bérard of the transfusion strategy.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Acronym: ATTRACS

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 11, 2022
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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