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

Launched by YI YANG · Aug 29, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called intravenous thrombolysis, which is used for patients experiencing an ischemic stroke. An ischemic stroke happens when a blood clot blocks blood flow to the brain, leading to symptoms like weakness or trouble speaking. The researchers are collecting information from patients to better understand how this treatment works and to improve decision-making for future care. The trial is currently looking for participants aged 18 and older who have had a stroke within the last 4.5 hours and show clear signs of neurological problems.

To join the study, potential participants should not have certain medical conditions that could complicate the treatment, such as recent significant head trauma or certain types of bleeding. Those who are interested can expect to receive standard care for their stroke, and their progress will be monitored closely throughout the study. This research aims to gather valuable data that could enhance treatment for stroke patients in the future, helping doctors make more informed choices about care.

Gender

ALL

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)