Aneurysmal Subarachnoid Hemorrhage, Intacranial Hypertension
Conditions
Keywords
Aneurysmal subarachnoid hemorrhage, Intraventricular intracranial pressure monitoring, Multicenter randomized clinical trail
Brief summary
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.
Detailed description
Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by a high mortality and disability rate, approximately 85% of SAH cases are attributed to ruptured intracranial aneurysms (RIAs), which is called aneurysmal SAH (aSAH). Improving the prognosis of patients with aSAH has become a pressing and significant issue. The rupture of an aneurysm results in a significant amount of blood entering the subarachnoid space, triggering an increase in intracranial pressure (ICP). This escalated ICP, coupled with the compression from the hematoma, severely impairs brain tissue function, leading to a cascade of irreversible neurological impairments, such as abnormal blood pressure, respiratory arrest, and cardiac arrest. Systematic reviews and meta-analysis found that the incidence rate of elevated ICP (ICP \> 20mmHg) in post-aSAH patients was 70.69%, with higher levels (according to the Hunt-Hess scale, WFNS scale, or modified Fisher grade) being more prevalent for increased ICP. The utilization of Intraventricular ICP monitoring in patients with aSAH offers the advantage of obtaining real-time, accurate data on intracranial pressure, enabling more precise and timely control of cranial pressure. However, there is a dearth of high-level randomized controlled trial evidence supporting the use of ICP in the treatment of aSAH. Given the potential utility of ICP monitoring in aSAH management and its current lack of high-level evidence in evidence-based medicine, we intend to pursue the research.
Interventions
DEVICEIntraventricular intracranial pressure monitoring
The postoperative management of ICP is guided by quantifiable Intraventricular ICP parameters. The remaining treatments are consistent with those in the control group.
Sponsors
Huashan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
s 1. Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset. 2. Age ≥ 18 years. 3. Symptom onset within 72 hours. 4. Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging. 5. Written informed consent obtained from the participant or legal representative.
Exclusion criteria
included 1. Pregnancy or lactation; 2. Bilateral fixed dilated pupils on admission; 3. Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease; 4. Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3; 5. Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect; 6. Subarachnoid haemorrhage caused by non-aneurysmal aetiologies; 7. Moyamoya disease associated aneurysmal rupture; 8. Other underlying diseases expected to substantially affect prognosis; 9. Active request for ICP monitoring by the patient or family; 10. Any other condition considered unsuitable for enrolment by two investigators; 11. Concurrent participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of good neurological functional prognosis | 90 days | The proportion of patients with modified Rankin Scale (mRS) scores 0-2. The mRS is an ordinal hierarchical scale ranging from 0 to 6, with higher scores indicating more severe disability. A mRS ≤ 2 indicated a good clinical outcome, and a mRS 5-6 indicated a poor clinical outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The rate of good neurological functional prognosis | 30 days, 180days | Proportion of patients with modified Rankin Scale (mRS) scores 0-2 |
| The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E) | 30 days, 90 days, 180days | The GOS-E is an ordinal hierarchical scale ranging from 1 to 8, with lower scores indicating more severe disability. |
| All-cause mortality | 90 days | Proportion of patients who died. |
| Incidence of hydrocephalus | 90 days | Incidence of symptomatic hydrocephalus requiring surgical intervention |
| Incidence of Delayed Cerebral Ischemia | 90 days | Proportion of delayed cerebral ischemia occurring within 90 days. |
| Incidence of epilepsy | 90 days | Proportion of symptomatic epilepsy occurring within 90 days. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORWei Zhu, Ph.D.
Department of Neurosurgery, Huashan Hospital, Fudan University
PRINCIPAL_INVESTIGATORXuehai Wu, Ph.D.
Department of Neurosurgery, Huashan Hospital, Fudan University
Outcome results
None listed