aneurysmal subarachnoid hemorrhage
Conditions
Interventions
group 1:Nimodipine injection was used for 7±2 days after surgery, and Nimodipine tablets 60mg/4h were continued to be used for 21 days
group 2:Nimodipine oral solution 60mg/4h to 21 days after surgery
group 3:Nimodipine injection was used for 7±2 days after surgery, and Nimodipine oral solution of 60mg/4h was continued to be used for 21 days
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients were included if they: 1) Age 18-75; 2) Patients with subarachnoid hemorrhage caused by intracranial saccular aneurysm rupture undergoing interventional surgery; 3) WFNS grades 2-4; 4) Patients using nimodipine within 48 hours *after aSAH; 5) Weight > 45kg; 6) After resuscitation, the hemodynamics were stable and the systolic blood pressure (SBP) was =100mmHg without the use of contractile drugs; 7) Modified Fisher grades >1. *The time of subarachnoid hemorrhage onset was defined as the time when the patient first had symptoms of subarachnoid hemorrhage (e.g., severe headache or loss of consciousness, as reported by the patient or a witness).
Exclusion criteria
Exclusion criteria: Patients with any of the following conditions were excluded from the study: 1) Expected to survive no more than 21 days 2) At any time after inclusion, intracranial pressure in sedated patients increased > 30 mmHg and lasted > 4 hours; 3) Major complications occur during the operation, including but not limited to intraoperative bleeding, brain swelling, arterial occlusion or aneurysm rupture that cannot be fixed; 4) Hemodynamic instability before administration (i.e. systolic blood pressure 6 L colloid or crystalloid fluid resuscitation); 5) Need CPR after SAH 6) Decompensated heart failure was identified by medical history within the past 6 months and/or physical examination at admission; 7) Acute myocardial infarction occurred within 3 months; 8) Severe or unstable concomitant symptoms or conditions (e.g., a known major neurologic deficit, cancer, hematologic disease, or coronary artery disease) or chronic medical conditions (e.g., psychiatric illness) that the investigator believes may increase the risk of study participation or study drug administration or may affect the interpretation of study findings; 9) The investigator think that they are not suitable to participate in the researchstudy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of subjects with favorable outcome at day 90 measured by the extended Glasgow outcome scale (GOSE =6); | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness evaluation indicators: Incidence of DCI and CVS within 21 days, incidence of cerebral edema and cerebral infarction within 90 days, and Montreal cognitive assessment at 90 days;Safety evaluation indicators: Hypotension, adverse events (phlebitis, vomiting, edema, diarrhea, rash, headache, etc.); | — |
Countries
China
Contacts
Public ContactNing Wang, Yueqiao Xu
Xuanwu Hospital ,Capital Medical University
Outcome results
None listed