Postoperative aneurysmal subarachnoid hemorrage patients
Conditions
Interventions
None listed
Sponsors
Research Institute for Brain and Blood Vessels-AKITA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The inclusion criteria were: (1) age 18 years or older, (2) initial aneurysmal subarachnoid hemorrhage (SAH), (3) pre-morbid modified Rankin Scale (mRS) score of 0 or 1, (4) aneurysm treatment performed during the first 72 hours (post-SAH day 3) after the initial hemorrhage, and (5) informed consent from the patient or the patient's legal representative. If the patient was not capable of giving informed consent and no legal representative was available, informed consent was given by an independent physician who was not involved in the patient's treatment or in conducting the trial.
Exclusion criteria
Exclusion criteria: The exclusion criteria were: (1) SAH of other than aneurysmal origin, (2) no hemorrhage visible on the initial the CT scan (modified Fisher Grade 1),1 (3) concurrent participation in another interventional trial (participation in an observational trial was not considered grounds for exclusion), (4) life expectancy of less than 1 year for reasons other than the current SAH, and (5) other concomitant severe disease (e.g., intracardiac shunting, long-term cardiac arrhythmia, significant valvular heart disease, or occlusive peripheral arterial disease) that might affect treatment requirements. After screening and recruitment, patients were not enrolled in any other DCI prevention trials.
Design outcomes
Primary
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Ischemic lesion retaled to DCI 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); Therapy related complication; relationship among cerebral autoregulation index (analyzed by rSO2 and blood pressure correlation), CO change (maximum change, slope), and rSO2 uptake to relieve neurologic deficits. 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
Outcome results
None listed