A Controlled, Prospective, Blinded, Randomized, Single-Center, Study of YSPSL for Prevention of Ischemic Reperfusion Injury in Patients Undergoing Cadaveric Orthotopic Liver Transplantation
试验速览
- 阶段
- 2 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Delayed graft function post transplant
研究概览
简要总结
The study is designed to assess the feasibility of evaluating YSPSL for the amelioration of ischemia reperfusion injury following liver transplantation by administering YSPSL into the liver graft directly ex vivo via the portal vein and to the recipient intravenously prior to reperfusion. Recently, P-selectin expression has been associated in liver grafts with prolonged cold storage times and rejection. By examining biomarkers of IRI including P-selectin by immunohistochemistry and/or quantitative PCR, liver histology and hepatic blood flow using established techniques, the goal of this study is to evaluate the feasibility of using these modalities for future studies of safety and efficacy.
详细描述
This will be a single-center, single-dose study. The study will be a randomized, double-blind, placebo-controlled, single-dose study. Patients who are undergoing cadaveric orthotopic liver transplantation and are at risk for development of DGF, based upon known risk factors, will be eligible to participate in the study. 12 patients will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient will be a recipient of a primary (first) ABO compatible cadaveric liver allograft;
- •Patient's age is >=18 years;
- •Patient is not a recipient of a multivisceral transplant or simultaneous kidney transplant;
- •Patient has not undergone prior organ or cellular transplant of any type;
- •Patient has a Model for End Stage Liver Disease (MELD) score of <28;
- •Cold ischemia time (CIT) anticipated to be less than 12 hours;
- •Donor liver procured by UCLA liver team;
- •Veno-veno bypass is not planned to be used for the patient (e.g. no prior surgery or other factor that indicates a risk for excessive blood loss and therefore a need for veno-veno bypass +/- autologous recovery during surgery);
- •For patients who are women of childbearing potential, patient has a negative pregnancy test (either urine or serum) within 48 hours prior to transplant;
- •Patient (male and female) is willing to use an acceptable form of birth control for at least 3 months post-treatment; and
- •Patient is willing and able to sign informed consent.
排除标准
- •Patient has a prior organ transplant of any type;
- •Patient has known allergic or intolerance reactions to human immune globulins, antibodies, or components of the formulation or known contraindication to administration of YSPSL;
- •Patient has an uncontrolled active infection (on antibiotics with controlled infection is not an exclusion) ;
- •Patient has active Hepatitis B virus (HBV)/transplant for HBV related cirrhosis;
- •Patient has previously participated in this study or another study with YSPSL;
- •Patient has received investigational therapy within 90 days prior to the transplant procedure;
- •Patient has current drug or alcohol abuse or, in the opinion of the investigator, is at risk for poor compliance with the visits in this protocol (no drug testing required);
- •Patient is a pregnant or nursing female, a female of childbearing potential planning to become pregnant within the duration of this study, or is not practicing birth control;
- •Patient is planned to receive a living donor liver transplant;
- •Patient lives >200 miles away or otherwise is not able to participate in study follow-up visits;
- •Donor body mass index >28;
- •Donor liver biopsy >20% macrosteototic fat;
- •Donor age >65.
研究组 & 干预措施
1
YSPSL (rPSGL-Ig)
干预措施: YSPSL (Drug)
2
干预措施: Placebo (Drug)
结局指标
主要结局
Delayed graft function post transplant
时间窗: 6 months
次要结局
- Liver function parameters through 6 months post transplant(6 months)