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Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage

Early versus Minimally-Invasive Goal-Directed Therapy on Delayed Cerebral Ischemia and Outcome after Subarachnoid Hemorrhage - Early vs. Miminally-Invasive Goal-Directed Therapy and SAH Outcome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007509
Enrollment
150
Registered
2012-03-15
Start date
2005-04-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Subarachnoid hemorrhage

Interventions

Early-intensive group, day 0 to 14 after SAH onset Minimally-invasive group, day 0 to 14 after SAH onset

Sponsors

Research Institute for Brain and Blood Vessels-AKITA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients were eligible if they were treated with surgical clipping or endovascular coiling for aneurysm.

Exclusion criteria

Exclusion criteria: Exclusion criteria were 1) both good grade (World Federation of Neurological Surgery [WFNS] grade I) and modest bleeds (Fisher CT grade<2), 2) renal disease (creatinine level >2.0 mg/dl) that may limit appropriate fluid loading for volume therapy, and 3) severe left ventricular dysfunction (ejection fraction <35%), intracardiac shunt, permanent cardiac arrhythmia, significant valvular heart disease, or occlusive peripheral arterial disease that may cause inaccurate CO analysis or may restrict hyperdynamic therapy using inotropic pressors.

Design outcomes

Primary

MeasureTime frame
Occurrence of clinical deterioration caused by DCI. Favorable outcome, defined as the proportion of patients with a modified Rankin score of 0 to 3.

Secondary

MeasureTime frame
Ischemic lesion was assessed by cerebral blood flow using SPECT combined with 3D-SSP analysis (days 7 and 14) and MR diffusion weighted images (days 14 and 21). Occurrences of cardiopulmonary complications, daily fluid intake/loss, and fluid balance calculated daily by subtracting urinary volume from total oral and intravenous intake. Fluid responsiveness using stroke volume variation, central venous pressure or pulmonary artery wedge pressure. Reliability of cardiac output and stroke volume among monitoring devices was also assessed.

Countries

Japan

Contacts

Public ContactTatsushi Mutoh

Research Institute for Brain and Blood Vessels-AKITA Department of Surgical Neurology

tmutoh@tiara.ocn.ne.jp018-833-0115

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026