Ischemic Stroke, Neuroprotection
Conditions
Brief summary
To explore the safety and feasibility of intra-arterial neuroprotective strategy in acute ischemic stroke patients who missed recanalization operation.
Interventions
Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
Sponsors
Hui-Sheng Chen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years; 2. Major neurologic deficits: 6≤NIHSS≤20; 3. Missing recanalization therapy (IVT or EVT) or progressive stroke, which was defined as symptoms worsen in 48 hours (an increase in NIHSS more than 4); 4. Premorbid mRS 0 or 1; 5. Signed informed consent.
Exclusion criteria
1. Modified Rankin Score \>2 caused by a history of prior stroke; 2. Patients who underwent intravenous thrombolysis or Endovascular treatment; 3. Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ \<80000/mm3; 4. Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis; 5. Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg); 6. Unsuitable for this clinical studies assessed by researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of server adverse events | 48 hours | server adverse events including femoral artery dissection, local thrombosis, seudoaneurysm, arteriovenousfistula, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with modified Rankin Score 0 to 1 | 90 days | Proportion of patients with modified Rankin Score 0 to 1 |
| Proportion of patients with modified Rankin Score 0 to 2 | 90 days | Proportion of patients with modified Rankin Score 0 to 2 |
| Modified Rankin Score | 90 days | Modified Rankin Score |
| Decrease in national institutes of health stroke scale (NIHSS) | 48 hours | Decrease in NIHSS scoring at 48 hours after the treatment |
| Proportion of symptomatic intracranial hemorrhage (sICH) | 48 hours | sICH was defined as 4 or more increase in NIHSS caused by hemorrhage |
| Proportion of intraparenchymal hemorrhage (PH1 and PH2) | 48 hours | Proportion of intraparenchymal hemorrhage (PH1 and PH2) within 48 hours after the treatment |
| Changes in cerebral edema | 48 hours | Cerebral edema was determined by cerebral volume or midline shift |
| All causes of death within 48 hours after the treatment | 48 hours | All causes of death within 48 hours after the treatment |
| Differences in serum factors levels in different artery region | 0 hour | Differences in serum factors levels in different Bessel region before recanalization |
Countries
China
Contacts
CONTACTHui-Sheng T Chen, Ph.D.
Outcome results
None listed