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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03756948
Other study ID # VETLT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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