ISRCTN77829558已完成未知
sing taurolidine to attenuate the surgically-induced endotoxaemia and the subsequent inflammatory response in patients with primary non-metastatic colon cancer
Geistlich Pharma AG (Switzerland)0 个研究点目标入组 60 人开始时间: 2007年11月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30081854
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Initial information at time of registration:
- •1. Patients of both genders who are 18 to 75 years of age
- •2. Patients with a solitary, non-metastatic extraperitoneal colonic tumour that already has been histologically confirmed
- •3. Patient has given full written informed consent
- •4. Elective setting
- •Added as of 25/11/2008:
- •5. Negative pregnancy test in women of childbearing age
排除标准
- •Amended as of 25/11/2008:
- •1. Rectal tumours (within 15 cm of the anal orifice)
- •2. Known allergy to taurolidine/taurine
- •3. Pregnant and lactating women
- •4. Liver disease:
- •4.1. Abnormal liver function tests (LFTs) greater than 2 times upper limit of normal (ULN)
- •4.2. International normalised ratio (INR) greater than 1.5
- •5. Renal disease:
- •5.1. Creatinine greater than 180 (women), greater than 150 (men)
- •5.2. Serum sodium less than 132 or greater than 145
- •6. Blood dyscrasia:
- •6.1. Neutropenia less than 1500 cells/cm^3
- •6.2. Thrombocytopenia less than 100,000 cells/cm^3
- •7. Intestinal obstruction
- •8. Infiltration of adjacent organs
- •9. Tumour diameter greater than 8 cm on computed tomography (CT) scan
- •10. Severe obesity (body mass index greater than 32 kg/m^2)
- •11. Operative risk greater than American Society of Anaesthesiologists (ASA) - III
- •12. Another cancer/malignant disease other than non melanoma skin cancer
- •13. Coexisting active inflammatory disorder (including active Rheumatoid Arthritis [RA], Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE])
- •14. Immunocompromised:
- •14.1. Corticosteroids
- •14.2. Immunosuppressive drugs
- •14.3. Patients with human immunodeficiency virus (HIV), chronic active hepatitis B or C virus
- •15. Active infection
- •Initial information at time of registration:
- •1. Known allergy to taurolidine/taurine
- •2. Pregnancy and lactation
- •3. Liver disease (abnormal Liver Function Test [LFT's] results or International Normalised Ratio [INR] greater than 1.5)
- •4. Renal disease
- •5. History of electrolyte imbalance
- •6. Blood dyscrasia (neutropenia less than 1500 cells/cm^3, thrombocytopenia less than 100,000 cells/cm^3)
- •7. Intestinal obstruction
- •8. Infiltration of adjacent organs
- •9. Tumour diameter greater than 8 cm on Computerised Tomography (CT) scan
- •10. Severe obesity (body mass index greater than 32 kg/m^2)
- •11. Operative risk greater than American Society of Anaesthesiologists (ASA) grade III
- •12. Another cancer/malignant disease
- •13. Another chronic inflammatory disorder (e.g. Rheumatoid Arthritis [RA], Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE])
- •14. Immunocompromised
- •15. Active infection
研究者
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