Clinical trial NCT03756948: Viscoelastic Tests-Guided Therapy In Liver Transplantation
Official title: Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Transplant; Complications
Bleeding
Hemostatic Disorder
Keywords: Liver Transplantation
Blood Coagulation Disorders
Blood Transfusion
Hemostasis
Thromboelastometry
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 237
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Perioperative bleeding and transfusion are important causes of morbidity and mortality in patients undergoing liver transplantation. The aim of this study is to assess whether viscoelastic tests-guided therapy with the use of synthetic factor concentrates impact transfusion rates of hemocomponents in adult patients undergoing liver transplantation.

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.


Eligibility criteria: Inclusion Criteria:

* Deceased Donor Liver Transplantation
* Chronic Liver Disease

Exclusion Criteria:

* Acute Liver Failure
* Combined Transplantation
* Re-Transplantation is Less Than 30 Days After the First Transplant

Primary outcomes:
measure: Need of Any Blood Products Transfusion
timeFrame: 48 Hours
Secondary outcomes:
measure: Use of Synthetic Factor Concentrates or Antifibrinolytic
timeFrame: 48 Hours
measure: Clinical Complications Related to the Procedure
timeFrame: Third days or until hospital discharge, whichever occurs first
measure: Duration of Mechanical Ventilation
timeFrame: Third days or until hospital discharge, whichever occurs first
measure: ICU Length of Stay
timeFrame: Third days or until ICU discharge, whichever occurs first
measure: Hospital Length of Stay
timeFrame: Third days or until hospital discharge, whichever occurs first
measure: In-Hospital Mortality
timeFrame: Third days or until hospital discharge, whichever occurs first
Other outcomes:
Locations:
Study officials:
affiliation: Physician and Researcher
name: Ary Serpa Neto, MD, MSc, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Raffael
name: Raffael PC Zamper, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
citation: 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.
citation: 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.
citation: 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.