Viscoelastic Tests-Guided Therapy In Liver Transplantation
NCT ID: NCT03756948
Last Updated: 2018-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
237 participants
INTERVENTIONAL
2007-01-01
2018-01-01
Brief Summary
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METHODS: This is an interventional before-after comparative study. Patients undergoing liver transplantation before the implementation of a protocol using thromboelastometry and synthetic factor concentrates were compared to patients after the implementation. Primary outcome was transfusion of any hemocomponents. Secondary outcomes included: transfusion of red blood cells (RBC), fresh frozen plasma (FFP), cryoprecipitate or platelets, clinical complications, length of stay and in-hospital mortality.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Usual Care (Before)
No Thromboelastometry No Synthetic Factor Concentrates Usual Care
Usual Care
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
Thromboelastometry-Guided Therapy (After)
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
Interventions
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Usual Care
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
Eligibility Criteria
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Inclusion Criteria
* Chronic Liver Disease
Exclusion Criteria
* Combined Transplantation
* Re-Transplantation is Less Than 30 Days After the First Transplant
18 Years
ALL
No
Sponsors
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Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Principal Investigators
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Ary Serpa Neto, MD, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
Physician and Researcher
Raffael PC Zamper, MD
Role: STUDY_DIRECTOR
Raffael
References
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Rana A, Petrowsky H, Hong JC, Agopian VG, Kaldas FM, Farmer D, Yersiz H, Hiatt JR, Busuttil RW. Blood transfusion requirement during liver transplantation is an important risk factor for mortality. J Am Coll Surg. 2013 May;216(5):902-7. doi: 10.1016/j.jamcollsurg.2012.12.047. Epub 2013 Mar 9.
Hartmann M, Szalai C, Saner FH. Hemostasis in liver transplantation: Pathophysiology, monitoring, and treatment. World J Gastroenterol. 2016 Jan 28;22(4):1541-50. doi: 10.3748/wjg.v22.i4.1541.
Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.
Wang SC, Shieh JF, Chang KY, Chu YC, Liu CS, Loong CC, Chan KH, Mandell S, Tsou MY. Thromboelastography-guided transfusion decreases intraoperative blood transfusion during orthotopic liver transplantation: randomized clinical trial. Transplant Proc. 2010 Sep;42(7):2590-3. doi: 10.1016/j.transproceed.2010.05.144.
Zamper RPC, Amorim TC, Queiroz VNF, Lira JDO, Costa LGV, Takaoka F, Juffermans NP, Neto AS. Association between viscoelastic tests-guided therapy with synthetic factor concentrates and allogenic blood transfusion in liver transplantation: a before-after study. BMC Anesthesiol. 2018 Dec 22;18(1):198. doi: 10.1186/s12871-018-0664-8.
Other Identifiers
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VETLT
Identifier Type: -
Identifier Source: org_study_id
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