EUCTR2014-002970-36-NL进行中（未招募）1 期
Human intestinal ischemia and reperfusion - Human intestinal IR
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Adult patients (18 years of age and older) undergoing major upper abdominal surgery
- •oWhipple-procedure or pylorus preserving pancreatico duodenectomy (PPPD)
- •oIleo-Jejunal bypass surgery
- •oRoux-en-Y gastric bypass
- •oTotal gastrectomy
- •oHepatico jejunostomy
- •oPancreaticojejunostomy (Frey’s procedure)
- •Patients who have given an informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 21
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 21
排除标准
- •<18 years of age or older but no proper understanding of the research proposal
- •Inflammatory bowel disease
- •Celiac disease
- •Acute major abdominal procedures
- •Patients who have refused informed consent
- •For the population who will receive tranexamic acid additional exclusion criteria have been formulated:
- •Active or history of thrombo-embolic disorders such as deep venous thrombosis, pulmonary embolism or cerebral embolism
- •History of blood coagulation disorder (hypercoagulation state)
- •Subarachnoid hemorrhage
- •Disseminated intravascular coagulation (DIS)
- •Severe renal insufficiency: i.e. serum kreatinine >150 µmol/L
- •History of convulsions
- •Known hypersensitivity of allergy for tranexamic acid
- •Simultaneous use of thrombolytics (e.g. alteplase, streptokinase)
- •Simultaneous use of hormonal anticonceptives or other substances that induce hemostasis.
- •For the population who will receive doxycycline additional exclusion criteria have been formulated:
- •Known hypersensitivity of allergy for tetracyclines.
- •Severe liver function disorder i.e. ASAT or ALAT or AF or ?-GT >150 U/L whether or not combined with severe renal insufficiency: i.e. serum kreatinine >150 µmol/L.
- •Severe renal insufficiency: i.e. serum kreatinine >150 µmol/L.
- •Myasthenia gravis
- •Simultaneous usage (or just before or after administration of doxycycline) of oral retinoids or substances containing metalions (such as antagel or ironpreparations)
- •Simultaneous use of methoxyflurane (anesthetic) or oral contraceptives
- •Bodyweight beneath 50 kg
- •History of blood coagulation disorder (inert hypocoagulation state)
- •Pregnancy or lactating
研究者
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