Hemorrhage Clinical Trial
— ATTRACSOfficial title:
Autotransfusion Versus Transfusion in Cancer Surgery
NCT number | NCT05452538 |
Other study ID # | ATTRACS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2021 |
Est. completion date | December 31, 2022 |
Verified date | February 2024 |
Source | Centre Leon Berard |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Centre Léon Bérard | Lyon | Rhône |
Lead Sponsor | Collaborator |
---|---|
Centre Leon Berard |
France,
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
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 |
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