Viscoelastic Tests-Guided Therapy In Liver Transplantation (VETLT)
2018年11月27日 更新者：Hospital Israelita Albert Einstein
Association Between Viscoelastic Tests-Guided Therapy With Synthetic Factor Concentrates And Allogenic Blood Transfusion In Liver Transplantation: A Before-After Study
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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
237
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：顺序分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Usual Care (Before)
No Thromboelastometry No Synthetic Factor Concentrates Usual Care
|
Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
|
|
实验性的：Thromboelastometry-Guided Therapy (After)
Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates
|
Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Need of Any Blood Products Transfusion
大体时间：48 Hours
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Use of Synthetic Factor Concentrates or Antifibrinolytic
大体时间：48 Hours
|
Any use of synthetic factor concentrates or antifibrinolytic
|
48 Hours
|
|
Clinical Complications Related to the Procedure
大体时间：Third days or until hospital discharge, whichever occurs first
|
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
|
|
Duration of Mechanical Ventilation
大体时间：Third days or until hospital discharge, whichever occurs first
|
Duration of mechanical ventilation in the post-operative period
|
Third days or until hospital discharge, whichever occurs first
|
|
ICU Length of Stay
大体时间：Third days or until ICU discharge, whichever occurs first
|
Duration of stay in the intensive care unit
|
Third days or until ICU discharge, whichever occurs first
|
|
Hospital Length of Stay
大体时间：Third days or until hospital discharge, whichever occurs first
|
Duration of stay in the hospital
|
Third days or until hospital discharge, whichever occurs first
|
|
In-Hospital Mortality
大体时间：Third days or until hospital discharge, whichever occurs first
|
Any death during hospitalization
|
Third days or until hospital discharge, whichever occurs first
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Ary Serpa Neto, MD, MSc, PhD、Physician and Researcher
- 研究主任：Raffael PC Zamper, MD、Raffael
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- Luddington RJ. Thrombelastography/thromboelastometry. Clin Lab Haematol. 2005 Apr;27(2):81-90. doi: 10.1111/j.1365-2257.2005.00681.x.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2007年1月1日
初级完成 (实际的)
2015年10月30日
研究完成 (实际的)
2018年1月1日
研究注册日期
首次提交
2018年11月16日
首先提交符合 QC 标准的
2018年11月27日
首次发布 (实际的)
2018年11月28日
研究记录更新
最后更新发布 (实际的)
2018年11月28日
上次提交的符合 QC 标准的更新
2018年11月27日
最后验证
2018年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Usual Care的临床试验
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