Viscoelastic Tests-Guided Therapy In Liver Transplantation

Bleeding Clinical Trial

— VETLT  

Official title:

Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756948
• Other study ID #: VETLT
• Status: Completed
• Phase: N/A
• Start date: January 1, 2007
• Est. completion date: January 1, 2018

Study information

• Verified date: November 2018
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: January 1, 2018
• Est. primary completion date: October 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bleeding
• Blood Coagulation Disorders
• Hemostatic Disorder
• Hemostatic Disorders
• Liver Transplant; Complications

Intervention

Other:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

References & Publications (5)

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. Review. — View Citation

Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. Review. — View 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. — View 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. — View Citation

Weber CF, Görlinger 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need of Any Blood Products Transfusion	Collapsed composite of need of any transfusion of blood product during surgery and in the first 48 hours in the postoperative, including the need of RBC, FFP, cryoprecipitate and/or platelets.	48 Hours
Secondary	Use of Synthetic Factor Concentrates or Antifibrinolytic	Any use of synthetic factor concentrates or antifibrinolytic	48 Hours
Secondary	Clinical Complications Related to the Procedure	Defined as: 1) Upper digestive hemorrhage; 2) Arterial thrombosis; 3) Infection; and/or 4) Any thromboembolic event	Third days or until hospital discharge, whichever occurs first
Secondary	Duration of Mechanical Ventilation	Duration of mechanical ventilation in the post-operative period	Third days or until hospital discharge, whichever occurs first
Secondary	ICU Length of Stay	Duration of stay in the intensive care unit	Third days or until ICU discharge, whichever occurs first
Secondary	Hospital Length of Stay	Duration of stay in the hospital	Third days or until hospital discharge, whichever occurs first
Secondary	In-Hospital Mortality	Any death during hospitalization	Third days or until hospital discharge, whichever occurs first