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临床试验/ITMCTR2100004353
ITMCTR2100004353已完成1 期

Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia Running title: Clinical observation of therapeutic effect of TXP in acute cerebralischemia

Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional 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
已完成
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
40 至 80(—)
性别
All

入选标准

  • 1. Cranial imaging: Ct showed no hemorrhage. Brain Mr Showed high DWI signal. No abnormalities were found with T2 t2FLAIR;
  • 2. The patient meets the diagnostic criteria of stroke in Chinese medicine and has the main symptoms mentioned above;
  • 3. Aged 40 to 80 years;
  • 4. Acute onset, onset time < 4.5 hours;
  • 5. Patients with moderate and moderate to severe stroke who scored 4-20 points;
  • 6. There was no significant difference in VAS scores;
  • 7. Blood routine, coagulation function, liver and kidney function were all normal;
  • 8. Obtain informed consent.

排除标准

  • 1. Suspected subarachnoid hemorrhage;
  • 2. A history of intracranial hemorrhage;
  • 3. There are intracranial tumors, arteriovenous malformations, and aneurysms;
  • 4. A history of major head trauma or cerebral infarction in the last 3 months; In the last 1 week, artery puncture occurred in the area not easy to compress hemostasis;
  • 5. Recent intracranial or intraspinal surgery;
  • 6. Blood glucose < 2.7 mmol/ L; Systolic bp > 180mmhg, or diastolic bp > 110mmhg;
  • 7. Patients with severe heart, liver, renal insufficiency or severe diabetes;
  • 8. With active bleeding;
  • 9. Acute bleeding tendency: Including platelet counts below 100*109/ L or other conditions; Oral anticoagulant, and inr > 1.7 or pt > 15s; Heparin treatment within 48 h (APTT beyond normal range)Direct thrombin or factor XA inhibitors are currently being used, And sensitive laboratory indicators(Such as APTT, INR, Platelet count, Snake vein enzyme coagulation time, Thrombin time or appropriate factor XA activity determination);
  • 10. Ct suggested a low-density range greater than 1/3 of the cerebral hemisphere;
  • 11. A pregnant or lactating woman;
  • 12. Allergic constitution(Allergic to more than 2 kinds of food or drugs);
  • 13. Known to be allergic to this drug and RTPA;
  • 14. Have participated in other drug trials within 2 months;
  • 15. The physician determines that the participant cannot or may not be able to complete the study.

研究者

发起方
Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional Chinese Medicine

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