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Neuroprotection in patients with cerebral aneurysm

Effect of remote ischemic preconditioning on delayed cerebral ischemia, cardiac and functional outcomes after aneurysmal subarachnoid hemorrhage: a prospective randomized controlled trial - RIPSAH

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059400
Enrollment
100
Registered
2023-11-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere

Interventions

Sponsors

NIMHANS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 65 years of age 2. Anterior cerebral circulation aneurysm with subarachnoid hemorrhage 3. WFNS grade 1-3 4. Presentation within 3 days of ictus 5. Scheduled to undergo microsurgical clipping of aneurysm

Exclusion criteria

Exclusion criteria: 1. Patients with upper limb cellulitis, ulcers, or peripheral vascular disease 2. WFNS grade > 3 3. Inadequate trans temporal window for TCD 4. Coiling or conservative management of aneurysm 5. Unruptured aneurysm

Design outcomes

Primary

MeasureTime frame
Incidence of delayed cerebral ischemiaTimepoint: CT Perfusion scan will be performed at baseline before the first remote ischemic preconditioning (RIPC) session, at any neurological deterioration, and on day 7 of ictus/at discharge whichever is earlier.

Secondary

MeasureTime frame
Biomarkers of cardiac and neuronal injuryTimepoint: Data regarding serum biomarkers of neuronal injury (NO, GFAP, UCHL1) will be collected before the first session of RIPC, at 6-12hours after the first RIPC, on neurological deterioration and day 7 of ictus or day of discharge (whichever is earlier). Data regarding cardiac biomarkers (Troponin I, BNP, CKMB) will be collected before the first session of RIPC, 6-12 hours after the first RIPC, in the event of any myocardial dysfunction, and day 7 of ictus or day of discharge (whichever is earlier);Cardiac and neurological outcomeTimepoint: Myocardial stauts and hemodynamic stability during the hospital stay. The neurological status will be assessed using the Glasgow coma scale (GCS) every 24 hours during the period of stay in the hospital and GOSE (Glasgow outcome scale-extended) score at discharge.;Incidence of Cerebral vasospasm Timepoint: Transcranial Doppler (TCD) assessment will be done every 24 hours until 7 days post ictus or until discharge, whichever is earlier. The mean cerebral blood flow velocities (MCBFV) of the ipsilateral pathological vessel & the middle cerebral arteries will be recorded.

Countries

India

Contacts

Public ContactSangeetha RP

National Institute of Mental Health and Neurosciences

sangeetharp14@gmail.com9480829770

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026