Clinical observation of therapeutic effect of Humanurinary kallindinogenase combined with Tianjiang Xueshuantong Pills in thrombolytic therapy of rtPA in acute cerebral ischemia

Phase 1

Completed

• Conditions: Acute cerebral infarction

• Registration Number: ITMCTR2100004353
• Lead Sponsor: Department of Encephalopathy, Tianjin Beichen District Hospital of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IHSS;Barthel;

Secondary Outcome Measures

Name	Time	Method
CRP and FIB;