ITMCTR2000003513招募中1 期
Clinical study of Jianpi Huayu Recipe in reducing blood hypercoagulability of advanced gastric cancer mediated by tissue factor
Jiangsu Province Hospital of Chinese Medicine0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 90（—）
- 性别
- All
入选标准
- •1. Patients with pathological diagnosis of Gastric cancer;
- •2. The TNM stage was III-IV;
- •3. Patients with dysfunction of blood coagulation and meet the two following criteria:
- •(1) PT shortening > 3s;
- •(2) APTT shortening > 3s;
- •(3) FIB > 4g/L; 4.DD > 0.5mg/l; 5.PLT > 300 * 10^9 / L;
- •4. Patients with criteria of TCM syndrome of blood stasis and weakened spleen and stomach;
- •5. Patients aged from 18 to 80 years old;
- •6. KPS score > 50;
- •7. Patients with life expectancy of at least 3 months;
- •8. No hemostasis, thrombolysis, anticoagulation, antiplatelet, non steroidal anti-inflammatory drugs or traditional Chinese medicine which effected of promoting blood circulation has been taken in the two weeks before admission;
- •9. Patients who provide written informed consent to participate in the study according to the GCP criteria.
排除标准
- •1. Patients who is unable to swallow oral medications including with digestive tract obstruction and jejunostomy;
- •2. Patients with symptomatic brain metastasis or mental disorder;
- •3. Patients with severe cardiovascular disease, chronic liver disease, kidney disease or blood disease;
- •4. Patients with active bleeding (massive bleeding) or bleeding tendency;
- •5. Patients with serious uncontrolled medical diseases or acute infection;
- •6. Patients whose laboratory examination before enrollment is abnormal according to the following criteria: Blood routine examination: ANC < 2.0 * 109 /L, Hb < 90g/L, PLT < 80 * 10^9 /L, Renal function: Cr > 1.5 * upper normal limit (UNL); CCr<50ml/minute, liver function: TBil > 1.5 * UNL, ALT(SGPT) and AST (SGOT) > 1.5 * UNL;
- •7. Patients who are pregnant, nursing;
- •8. Patients who are substance abuse, or with clinical, mental, and social features which is interference for the study and informed consent.
研究者
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