Clinical trial NCT03997292: Intravenous Thrombolysis Registry for Acute Ischemic Stroke in China
Official title: Intravenous ThrombolysisRegistry for Acute Ischemic Stroke in China
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ischemic Stroke
Keywords: alteplase; urokinase; intravenous thrombolysis
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2019-06-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thrombolytic patients with acute ischemic stroke within 3 hours of onset

Brief summary: To analyze the real situation of intravenous thrombolysis in acute ischemic stroke in China

Detailed description: Compare the efficacy and safety of different thrombolytic drugs; Analysis of patients during hospital treatment of adverse events and complications; Analysis of factors that affect the effectiveness of treatment; Evaluate the pharmacological benefits of different thrombolytic drugs

Eligibility criteria: Inclusion Criteria:

* 1) age\> 18 years old;
* 2) meet the diagnostic criteria of China 2014 guidelines for the diagnosis and treatment of acute ischemic stroke;
* 3) no history of first sepsis or previous cerebral infarction sequelae (mRS ≤ 1);
* 4) within 3 hours of onset;
* 5) Have measurable neurological deficits;
* 6) Patients or legal guardians can understand and sign informed consent.

Exclusion Criteria:

* Absolute exclusion criteria:
* 1) history of head trauma or stroke within the last 3 months;
* 2) suspected subarachnoid hemorrhage;
* 3) history of previous intracranial hemorrhage;
* 4) intracranial tumor, arteriovenous malformation or aneurysm ;
* 5) recent intracranial or intraspinal surgery;
* 6) arterial puncture at an incurable site within the last 7 days;
* 7) elevated blood pressure: systolic blood pressure ≥180 mm Hg, or diastolic blood pressure ≥100 mm Hg;
* 8) Internal bleeding;
* 9) acute bleeding tendency, including platelet count less than 100 × 109 / L or other conditions;
* 10) heparin treatment within 48 h (APTT is outside the upper limit of normal range);
* 11) oral anticoagulant, INR\> 1.7 Or PT\> 15S;
* 12) are currently using thrombin inhibitors or factor Xa inhibitors, various sensitive laboratory abnormalities (such as APTT, INR, platelet count, ECT; TT or appropriate factor Xa activity assays) ;
* 13) Blood glucose \<50 mg / dl (2.7 mmol / L);
* 14) CT suggestive of multiple cerebral infarction (low density range\> 1/3 of the cerebral hemispheres) ;
* 15) Other conditions considered unsuitable for inclusion in this clinical study;
* 16) 3 months or are participating in other clinical trials;
* 17) combined with severe systemic disease is expected to survive less than three months.
* Relative exclusion criteria:
* 1) severe stroke (NIHSS\> 25 points);
* 2) pregnancy;
* 3) neurological deficits after epileptic seizures;
* 4) major surgery or severe trauma within the last 14 days;
* 5) Urethral hemorrhage;
* 6) Myocardial infarction within the last 3 months;

Primary outcomes:
measure: mRS of 90 days after thrombolysis
timeFrame: Month 3
Secondary outcomes:
measure: Evaluation of Adverse events
timeFrame: Year 1
Other outcomes:
measure: Economic evaluation
timeFrame: Day 14
Locations:
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
affiliation: Neurology Chief
name: Huisheng Chen, doctor
role: PRINCIPAL_INVESTIGATOR
References: