Understanding the Alterations in Coagulation Factor Levels in Patients With End Stage Liver Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Factor IX level
研究概览
简要总结
The goal of this observational study is to learn about the changes in coagulation factor VIII and IX levels in patients undergoing liver transplantation to help guide future management of coagulation factor replacement in patients with hemophilia and liver disease. The question we aim to answer is: should the recommendations for factor replacement in patients with hereditary bleeding disorders be altered in the setting of end stage liver cirrhosis?
Participants will be asked to provide two blood samples, one at the beginning of their liver transplant, and one after their liver transplant.
详细描述
Current guidelines for management of hemophilia B suggest replacement of factor IX to 100% prior to major abdominal surgery. However, in patients with concurrent liver cirrhosis where the liver does not produce Factor IX, is it worth considering adjusting the factor replacement strategy? We recently had a case of a patient with Hemophilia B and end-stage liver disease (ESLD) who underwent orthotopic liver transplantation and received the standard pre-operative recombinant factor IX replacement. His case was complicated by intra-cardiac thrombus and hypotension. We conduct a small study to assess the pre-operative thromboelastography (TEG) and factor levels in ESLD patient which we hope will help guide clinical decision making in future hemophilia B patients with cirrhosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants who have end stage liver disease who are listed for liver transplantation and have an accepted organ offer
- •age > 18+
- •MELD > 25
排除标准
- •undergoing multi-organ transplant
- •tumor MELD exception points
- •has hereditary coagulation disease
- •currently on therapeutic blood thinner or anti-platelet medication (ie. aspirin, plavix, warfarin, heparin)
结局指标
主要结局
Factor IX level
时间窗: 12 hours
We will collect Factor IX level pre- and post- transplant
Factor VIII level
时间窗: 12 hours
We will collect Factor VIII level pre- and post- transplant
Thromboelastography (TEG) values
时间窗: 12 hours
We will collect thromboelastography values pre- and post- transplant
次要结局
- Complications(24 hours)
研究者
Alexandra Ruan
Clinical Assistant Professor
Stanford University