Clinical trial NCT05452538: AutoTransfusion Versus TRAnsfusion in Cancer Surgery
Official title: Autotransfusion Versus Transfusion in Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhage
Cancer Surgery
Transfusion
Keywords: intraoperative blood salvage
cancer surgery
pharmacoeconomic analysis
transfusion
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2022-07-11
Enrollment: 5808
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all adult patients who underwent surgery at the Centre Léon Bérard in 2021 and were transfused from the day of surgery to the 10th postoperative day

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of annual uses of the intraoperative blood recovery system
timeFrame: Up to 1 year
Secondary outcomes:
measure: annual cost for the Centre Léon Bérard of the transfusion strategy.
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
state: Rhône
Study officials:
References:
citation: Klein AA, Bailey CR, Charlton AJ, Evans E, Guckian-Fisher M, McCrossan R, Nimmo AF, Payne S, Shreeve K, Smith J, Torella F. Association of Anaesthetists guidelines: cell salvage for peri-operative blood conservation 2018. Anaesthesia. 2018 Sep;73(9):1141-1150. doi: 10.1111/anae.14331. Epub 2018 Jul 10.
citation: Waters JH, Yazer M, Chen YF, Kloke J. Blood salvage and cancer surgery: a meta-analysis of available studies. Transfusion. 2012 Oct;52(10):2167-73. doi: 10.1111/j.1537-2995.2011.03555.x. Epub 2012 Feb 10.
citation: Ubee SS, Manikandan R, Gudimetla AR, Singh G. Cost benefits of intraoperative cell salvage in radical cystectomy. Indian J Urol. 2010 Apr;26(2):196-9. doi: 10.4103/0970-1591.65386.
citation: Araujo RL, Pantanali CA, Haddad L, Rocha Filho JA, D'Albuquerque LA, Andraus W. Does autologous blood transfusion during liver transplantation for hepatocellular carcinoma increase risk of recurrence? World J Gastrointest Surg. 2016 Feb 27;8(2):161-8. doi: 10.4240/wjgs.v8.i2.161.