aSAH Treatment Based on Intraventricular ICP Monitoring: A Prospective, Multicenter, Randomized and Controlled Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHuashan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Confirmed diagnosis of aSAH: presence of SAH symptoms, confirmed by CT scan or lumbar puncture. CTA or DSA confirms ruptured intracranial aneurysm (IA) as the cause. Decision made to perform craniotomy clipping or endovascular treatment within 72 hours aiming for a single procedure to cure the bleeding artery aneurysm;
Age ≥ 18 years;
The onset of symptoms should occur within 72 hours;
The Hunt-Hess grade is between 2 and 4, and the CT imaging findings correspond to a modified Fisher grade of 2 to 4.
Disqualifiers
Pregnancy or lactation period;
Patients presenting with bilateral dilated pupils upon admission;
Patients with concurrent tumors, hemorrhagic diseases, or other severe underlying conditions (such as chronic obstructive pulmonary disease, multiple organ dysfunction syndrome, severe diabetes mellitus, congestive heart failure, and chronic kidney disease);
Patients with a history of brain disorders or previous brain surgeries;
Trial design
Design model
Parallel
Treatments tested in this trial
Intraventricular intracranial pressure monitoring
DeviceThe postoperative management of ICP is guided by quantifiable Intraventricular ICP parameters. The remaining treatments are consistent with those in the control group.
Treatment groups
372 Participants
are divided into 2 treatment groupsGroup A: aSAH treatment based on Intraventricular ICP monitoringExperimental treatment 1 intervention
Group B: aSAH treatment without Intraventricular ICP monitoringNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
The rate of good neurological functional prognosis
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.
Time frame
90 daysSecondary outcomes
1
The rate of good neurological functional prognosis
Proportion of patients with modified Rankin Scale (mRS) scores 0-2
Time frame
30 days, 180days2
The rate of good prognosis by Glasgow Outcome Scale-Extended (GOS-E)
The GOS-E is an ordinal hierarchical scale ranging from 1 to 8, with lower scores indicating more severe disability.
Time frame
30 days, 90 days, 180days3
Mortality
Proportion of patients who died.
Time frame
30 days, 90 days, 180days4
Incidence of VP shunt-related hydrocephalus
Incidence of hydrocephalus requiring ventriculoperitoneal shunt within 90days.
Time frame
90 daysOther outcomes
1
Incidence of intracranial infection
The cerebrospinal fluid culture demonstrates positive findings for pathogenic bacteria, or the cerebrospinal fluid exhibits an elevated count of more than 1000 white blood cells with a predominance of polymorphonuclear cells, accompanied by decreased glucose levels and increased lactate levels in the cerebrospinal fluid.
Time frame
90 days2
Incidence of bleeding from puncture site
This refers to intracranial bleeding resulting from ventricular puncture, which can be confirmed via a head CT scan.
Time frame
90 days3
Incidence of poor healing in surgical incisions
This encompasses infection and suppuration at the ICP incision site, potentially impeding proper wound closure.
Time frame
90 daysSponsors and contacts
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Source ClinicalTrials.gov