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Acute Ischemic Stroke Thrombolysis Evaluation in Hubei Province:a Prospective, Multi-center, Real-word Study(Steady)

Acute Ischemic Stroke Thrombolysis Evaluation in Hubei Province:a Prospective, Multi-center, Real-word Study(Steady)

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071671
Enrollment
Unknown
Registered
2023-05-22
Start date
2023-05-23
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic cerebral stroke

Interventions

TNK (0.25mg/kg, = 25mg, 5-10s intravenous injection):N/A
rt-PA (0.9mg/kg, = 90mg, initial 10% intravenous infusion, remaining 90% intravenous infusion = 1h):N/A
urokinase (1 million U to 1.5 million U, intravenous infusion for 30 minutes):N/A

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or non pregnant female = 18 years old; 2. Time from onset to treatment ? 6 h; The time when symptoms begin is defined as the 'last time they appear normal'; 3. Independent neurological function before stroke (mRS 0-1); 4. Meet the conditions for intravenous thrombolysis, with a baseline NIHSS score of 4-26 points; 5.Written informed consent was provided by all participants or their representatives before their enrolment

Exclusion criteria

Exclusion criteria: 1. Any one of the following should be excluded and cannot be selected: 2. Severe neurological deficits (mRS = 2) prior to onset; 3. Have a history of intracranial hemorrhage; Intracranial tumors, arteriovenous malformations, or aneurysms; 4.Significant head injury or stroke, intracranial or spinal cord surgery within 3 months; 5. Major surgery or severe trauma within the past 30 days; 6. Digestive or urinary system bleeding in the last 30 days; 7. Myocardial infarction within the past three months; 8. Arterial puncture in non compressible area within the past 7 days; 9. Acute bleeding or active internal bleeding; 10. Platelet count1.6; 13. High blood pressure (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg); 14. Blood glucose concentration<50mg/dl (2.7mmol/L); 15. Pregnancy; 16. Residual neurological deficits after seizures; 17. Allergies to research drugs; 18. Those with severe diseases of other organs and an expected life of no more than 6 months; 19. Other situations that the researcher deems unsuitable for participation in this clinical study.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with favourable functional outcomes (defined as an mRS score of 0–2 at 90 days);;Analysis of time delay of pre-hospital of intravenous thrombolysis in acute ischemic stroke;

Secondary

MeasureTime frame
The proportion of patients with a substantial neurological improvement on the NIHSS (defined as a decrease of at least 4 points at 24 h) or the score of the NIHSS score decreased compared to the baseline;The ordered distribution of mRS score at 90 days;90-day mortality rate;The time of hospital stay and intensive care unit time, and hospitalization costs;

Countries

PR China

Contacts

Public ContactSuiqiang Zhu

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

zhusuiqiang@163.com+86 130 3510 1141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026