Status:
NOT_YET_RECRUITING
Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage
Lead Sponsor:
Beijing Tiantan Hospital
Collaborating Sponsors:
Development Center for Medical Science & Technology National Health Commission of the People's Republic of China
Tianjin Medical University General Hospital
Conditions:
Aneurysmal Subarachnoid Hemorrhage
Aneurysmal Subarachnoid Hemorrhage (aSAH)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn if elevating postoperative blood pressure works to improve prognosis in aneurysmal subarachnoid hemorrhage (aSAH) patients. The main questions it aims to an...
Eligibility Criteria
Inclusion
- 1\) Aged 18-75 years;
- 2\) Patients who underwent clipping or endovascular intervention within 72 hours post-ictus;
- 3\) Intracranial aneurysm diagnosis confirmed by operating surgeons (including neurosurgeons or neurointerventionalists) through imaging findings, intraoperative visualization, or angiography, with subarachnoid hemorrhage (SAH) attributable to the ruptured aneurysm lesion (verified via imaging, xanthochromic cerebrospinal fluid, or intraoperative observation);
- 4\) Hunt-Hess grade 1-4 at onset;
Exclusion
- 1\) Presence of untreated intracranial aneurysms with rupture risk;
- 2\) Moderate-to-severe cerebral vasospasm confirmed by pre-enrollment digital subtraction angiography (DSA), transcranial Doppler (TCD), or computed tomography angiography (CTA);
- 3\) Intracranial massive hematoma (e.g., volume \>30 mL with midline shift \>5 mm) causing severe cerebral herniation, as evidenced by admission CT or other imaging modalities;
- 4\) Prior cranial neurosurgery for other central nervous system disorders;
- 5\) Comorbid major systemic diseases or multi-organ dysfunction with life expectancy \<1 year, potentially compromising study implementation or follow-up observations;
- 6\) Poorly controlled hypertension despite regular antihypertensive medication (e.g., systolic blood pressure \>160 mmHg during pharmacotherapy);
- 7\) Pre-onset modified Rankin Scale (mRS) score \>2 points, indicating disability from other causes;
- 8\) Intraoperative major complications including but not limited to massive cerebral hemorrhage, hypovolemic shock, or malignant brain swelling;
- 9\) Anticipated inability to complete scheduled follow-up assessments within 180 days;
- 10\) Pregnancy.
Key Trial Info
Start Date :
August 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT07149922
Start Date
August 31 2025
End Date
July 31 2028
Last Update
September 2 2025
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 107000