Bleeding Clinical Trial
— VETLTOfficial title:
Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
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 |
Verified date | November 2018 |
Source | Hospital Israelita Albert Einstein |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hospital Israelita Albert Einstein |
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
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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