NL-OMON43970招募中2 期
Human intestinal ischemia and reperfusion - Human intestinal IR
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult patients (18 years of age and older) undergoing major upper abdominal surgery
- •o Whipple-procedure or pylorus preserving pancreatico duodenectomy (PPPD)
- •o Ileo-Jejunal bypass surgery
- •o Roux-en-Y gastric bypass
- •o Total gastrectomy
- •o Hepatico jejunostomy
- •o Pancreaticojejunostomy (Frey*s procedure)
- •Patients who have given an informed consent
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 γ-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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Oxygen deficiency of the human bowelThe participants enrolled in this study will all undergo major upper abdominal surgery (i.e. mostly Pylorus Preserving Pancreatico Duodenectomy or whipple procedure) mostly for pancreatic cancer, papillary carcinoma or pancreatitis. However, the indication for which the IMP is administered is intestinal ischemia and reperfusion.EUCTR2014-002970-36-NLMaastricht University Medical Center
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