AutoTransfusion Versus TRAnsfusion in Cancer Surgery

Hemorrhage Clinical Trial

— ATTRACS  

Official title:

Autotransfusion Versus Transfusion in Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05452538
• Other study ID #: ATTRACS
• Status: Completed
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2024
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5808
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Transfusion

Intervention

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.

Locations

Country	Name	City	State
France	Centre Léon Bérard	Lyon	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Centre Leon Berard

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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