AutoTransfusion Versus TRAnsfusion in Cancer Surgery

NCT05452538 | Completed

• 1 other identifier: ATTRACS
• Study Type: observational
• Target: 5,808
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage; Cancer Surgery; Transfusion

Keywords

intraoperative blood salvage; cancer surgery; pharmacoeconomic analysis; transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Up to 1 year

Study Arms (1)

cancer surgery

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

Device: Transfusion

Interventions

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.

cancer surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Surgery at the Centre Léon Bérard in 2021
• transfusion from the day of surgery to the 10th postoperative day

You may not qualify if:

• Digestive endoscopy, interventional radiology, brachytherapy
• Vascular access only
• Patient refusal

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, Rhône, 69008, France

Location

Related Publications (4)

• 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.

  PMID: 29989144 BACKGROUND

• 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.

  PMID: 22321196 BACKGROUND

• 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.

  PMID: 20877596 BACKGROUND

• 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.

  PMID: 26981190 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Blood Transfusion

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: January 1, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)