Clinical Outcome in patient with cerebral vasospasm after aneurysmal subarachnoid hemorrhage treated with intra-arterial Nimodipine infusion: A Randomized Controlled Trial

Phase 2

Completed

• Conditions: Aneurysmal subarachnoid hemorrhageCerebral Vasospasm; aneurysm; vasospasm; intra- arterial; nimodipine

• Registration Number: TCTR20200121002
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-12-01
• Study Start: 2020-01-21
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

ASAH patients, ranging in age 18 - 80 years, on whom aneurysm obliteration was performed, either by surgical clipping or endovascular therapy
After aneurysm obliteration, digital subtraction diagnostic angiography was performed on all patients. If angiographic vasospasm was demonstrated, we enrolled the patients, whether or not they suffered any clinical vasospasm, such as alteration of consciousness, new motor deficits, or unexplained fever. Consent was informed and obtained from the patients or their relatives, as appropriate
Every angiography was done within 14 days, according to the date of rupture, otherwise the case was excluded. After we found any angiographic vasospasm (defined as any acute tapering or focal vasoconstriction of any vessels compared to prior diagnostic imaging), we categorized patients into good neurological baseline group, defined as World Federation of Neurological Surgeons’ score (WFNS) grade I-III, and poor neurological baseline group defined as WFNS grade IV-V first, and then performing block randomization into 1:1 of the intervention and control groups

Exclusion Criteria

No angiographic vasospasm
Angiography done after 14 days
Denied consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eurological Outcome 6 months after intervention WFNS, Glasgow Coma Scale (GCS), and motor power, Glasgow Outcome Scale (GOS), modified Rankin Scale

Secondary Outcome Measures

Name	Time	Method
Angiographic outcome After intervention caliber of vessels suspected of vasospasm