Research on intravenous thrombolysis for ischemic stroke in Northeast China

Clinical Research of Intravenous Thrombolysis for Ischemic Stroke in Northeast of China

This study is testing how well a specific treatment for stroke works by looking at patient data to see if it can help doctors make better decisions and improve recovery.

Quick facts

• Study type: Observational
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Hospital of Jilin University (Academic / other)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05028868 on ClinicalTrials.gov

What this trial studies

This research focuses on the treatment of acute ischemic stroke using intravenous thrombolysis. By creating a comprehensive database of patients who meet the criteria for this therapy, the investigators aim to analyze various factors such as biochemical markers and imaging results. The goal is to identify significant correlations that could lead to improved treatment decisions and better patient outcomes. This observational study will gather detailed clinical information and follow-up data to enhance understanding of the condition and its management.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with ischemic stroke and have measurable neurological deficits.

Not a fit: Patients with recent significant head trauma, prior strokes, or other specified contraindications may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved treatment protocols for patients suffering from ischemic stroke.

How similar studies have performed: Other studies on intravenous thrombolysis for ischemic stroke have shown promising results, indicating that this approach is supported by existing evidence.

Eligibility criteria

Inclusion Criteria:

1. Diagnosis of ischemic stroke causing measurable neurological deficit
2. Onset of symptoms \<4.5 h before treatment begins
3. Age ≥18 y

Exclusion Criteria:

1. Significant head trauma or prior stroke in the previous 3 mo
2. Symptoms suggest SAH
3. Arterial puncture at noncompressible site in previous 7 d
4. History of previous intracranial hemorrhage
5. Intracranial neoplasm, AVM, or aneurysm
6. Recent intracranial or intraspinal surgery
7. Elevated blood pressure (systolic \>185 mm Hg or diastolic \>110 mm Hg)
8. Active internal bleeding
9. Acute bleeding diathesis, including but not limited to
10. Platelet count \<100 000/mm3
11. Heparin received within 48 h resulting in abnormally elevated aPTT above the upper limit of normal
12. Current use of anticoagulant with INR \>1.7 or PT \>15 s
13. Current use of direct thrombin inhibitors or direct factor Xa inhibitors with elevated sensitive laboratory tests (eg, aPTT, INR, platelet count, ECT, TT, or appropriate factor Xa activity assays)
14. Blood glucose concentration \<50 mg/dL (2.7 mmol/L)
15. CT demonstrates multilobar infarction (hypodensity \>1/3 cerebral hemisphere)
16. Relative exclusion criteria
17. Recent experience suggests that under some circumstances, with careful consideration and weighting of risk to benefit, patients may receive fibrinolytic therapy despite ≥1 relative contraindications. Consider risk to benefit of intravenous rtPA administration carefully if any of these relative contraindications is present
18. Only minor or rapidly improving stroke symptoms (clearing spontaneously)
19. Pregnancy
20. Seizure at onset with postictal residual neurological impairments
21. Major surgery or serious trauma within previous 14 d
22. Recent gastrointestinal or urinary tract hemorrhage (within previous 21 d)
23. Recent acute myocardial infarction (within previous 3 mo)

Where this trial is running

Changchun, Jilin

• First Hospital of Jilin University — Changchun, Jilin, China (Recruiting)

Study contacts

• Study coordinator: Yi Yang, MD，PhD

Conditions Ischemic Stroke; Thrombosis; ischemic stroke; thrombolysis