Viscoelastic Tests-Guided Therapy In Liver Transplantation

NCT ID: NCT03756948

Last Updated: 2018-11-28

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

237 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-01

Study Completion Date

2018-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Transplant; Complications Bleeding Hemostatic Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care (Before)

No Thromboelastometry No Synthetic Factor Concentrates Usual Care

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components

Thromboelastometry-Guided Therapy (After)

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Group Type EXPERIMENTAL

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Intervention Type OTHER

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

Intervention Type OTHER

Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates

Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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.

Reference Type BACKGROUND
PMID: 23478547 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26819521 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15784122 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22914710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20832550 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30579327 (View on PubMed)

Other Identifiers

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VETLT

Identifier Type: -

Identifier Source: org_study_id

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