Viscoelastic Tests-Guided Therapy In Liver Transplantation

NCT03756948 | Completed

• 1 other identifier: VETLT
• Study Type: interventional
• Target: 237
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Liver Transplant; Complications; Bleeding; Hemostatic Disorder

Keywords

Liver Transplantation; Blood Coagulation Disorders; Blood Transfusion; Hemostasis; Thromboelastometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Use of Synthetic Factor Concentrates or Antifibrinolytic

  48 Hours

• Clinical Complications Related to the Procedure

  Third days or until hospital discharge, whichever occurs first

• Duration of Mechanical Ventilation

  Third days or until hospital discharge, whichever occurs first

• ICU Length of Stay

  Third days or until ICU discharge, whichever occurs first

• Hospital Length of Stay

  Third days or until hospital discharge, whichever occurs first

Study Arms (2)

Usual Care (Before)

ACTIVE COMPARATOR

No Thromboelastometry No Synthetic Factor Concentrates Usual Care

Other: Usual Care

Thromboelastometry-Guided Therapy (After)

EXPERIMENTAL

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Other: Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Interventions

Usual Care OTHER

Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components

Usual Care (Before)

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates OTHER

Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates

Thromboelastometry-Guided Therapy (After)

Eligibility Criteria

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

You may qualify if:

• Deceased Donor Liver Transplantation
• Chronic Liver Disease

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Related Publications (6)

• 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.

  PMID: 23478547 BACKGROUND

• 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.

  PMID: 26819521 BACKGROUND

• Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.

  PMID: 15784122 BACKGROUND

• 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.

  PMID: 22914710 BACKGROUND

• 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.

  PMID: 20832550 BACKGROUND

• 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.

  PMID: 30579327 DERIVED

MeSH Terms

Conditions

Hemorrhage; Hemostatic Disorders; Blood Coagulation Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Ary Serpa Neto, MD, MSc, PhD

  Physician and Researcher

  PRINCIPAL INVESTIGATOR

• Raffael PC Zamper, MD

  Raffael

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: November 28, 2018
• Study Start: January 1, 2007
• Primary Completion: October 30, 2015
• Study Completion: January 1, 2018
• Last Updated: November 28, 2018

Record last verified: 2018-11