Skip to content

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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20200121002
Enrollment
Unknown
Registered
2020-01-21
Start date
2016-06-05
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal subarachnoid hemorrhage Cerebral Vasospasm aneurysm vasospasm intra&#45

Interventions

The intervention group received intra&#45
arterial Nimodipine infusion in a dosage range of 1&#45
5 mg in each vessel&#44
at the rate of 1 mg per 5 minutes (maximum dosage must not exceed 10 mg) directly into the artery in which a 5&#45
French vertebral catheter was placed in the cervical region. The total dosage of Nimodipine infusion depended on significant angiographic improvement and was observed for any complications&#44
such as hypotension and bradycardia,No intra&#45
arterial nimodipine infusion
Experimental Drug,No Intervention No treatment

Sponsors

None
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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

Exclusion criteria: No angiographic vasospasm Angiography done after 14 days Denied consent

Design outcomes

Primary

MeasureTime frame
Neurological Outcome 6 months after intervention WFNS, Glasgow Coma Scale (GCS), and motor power, Glasgow Outcome Scale (GOS), modified Rankin Scale

Secondary

MeasureTime frame
Angiographic outcome After intervention caliber of vessels suspected of vasospasm

Countries

Thailand

Contacts

Public ContactVich Yindeedej

Thammasat University Hospital

vich2001@hotmail.com029269523

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026