Treating Acute Pancreatitis With Dabigatran, a Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
Researchers are studying the safety and efficacy of Dabigatran in the treatment of acute pancreatitis.
详细描述
Subjects with acute pancreatitis who meet the inclusion and exclusion criteria for the study will be recruited. Subjects will be randomized to receive either Dabigatran 150mg daily for three days or standard treatment. Vital signs, CBC, inflammatory markers and BMP, and bleeding complications will be evaluated daily for the next 7 days of until discharge whichever is sooner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute Pancreatitis (presence at least two of three features: typical pain, amylase or lipase >3 times UNL and AP on images)
- •18-75 years old
- •Willingness to sign the informed consent
- •Symptom onset within 72 hours
排除标准
- •Under 18 years of age or over 75 years of age
- •Pregnancy or lactating
- •Presence of pseudo aneurysm on CT
- •Predicted severe acute pancreatitis
- •Unwilling or unable to sign the informed consent
- •Had recent surgery or sphincterotomy
- •Active pathological bleeding
- •Concurrent use of anti-coagulation
- •Known serious hypersensitivity reaction to Dabigatran
- •CrCI <30mL/min or on dialysis
- •Mechanical prosthetic valves
- •Liver disease
- •On Chemotherapy or immunosuppressant
- •Persistent ALT, AST, Akl Phos >2 x ULN
- •Active hepatitis C, active hepatitis B, and active hepatitis A
- •Anemia (hemoglobin <10g/dL)
- •Thrombocytopenia
- •Concomitant use of P-gp inhibitors
研究组 & 干预措施
Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
干预措施: Dabigatran Etexilate Mesylate (Drug)
Dabigatran Etexilate Mesylate
Dabigatran 150mg BID for 3 days
干预措施: Standard of Care (Other)
Standard of Care
Standard treatment for acute pancreatitis
干预措施: Standard of Care (Other)
结局指标
主要结局
Adverse Events
时间窗: One year
Number of Reported Adverse Events
次要结局
未报告次要终点