Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Functional outcome
研究概览
简要总结
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 answer are:
Does elevating postoperative blood pressure can improve the prognosis of aSAH ? What safety problems do participants have when received elevating blood pressure measurement?
Participants will:
Receive elevating or lowering blood pressure therapy in 72 hours after randomization, in order to maintain blood pressure within predefined target ranges Receive follow-up at 30 days, 90 days, and 180 days after randomization
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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.
研究组 & 干预措施
Elevated Target Blood Pressure
Blood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <160 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 160-180 mmHg (≤160 mmHg and ≥120 mmHg). For SBP >180 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 160-180 mmHg range. For SBP within the range of 160-180 mmHg, standard supportive care was provided.
干预措施: Blood pressure was regulated within the elevated target management range (Other)
Normal Target Blood Pressure
Blood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP <120 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 120-160 mmHg (<160 mmHg and >120 mmHg). For SBP >160 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 120-160 mmHg, standard supportive care was provided.
干预措施: Blood pressure was regulated within the normal target management range (Other)
结局指标
主要结局
Functional outcome
时间窗: Patients received follow-up through telephone consultations or outpatient appointments in the 180 days after randomization. The functional outcome was assessed by the mRS at 90 days post-discharge. mRS 0-2 was considered as favorable clinical outcome.
The modified Rankin Scale (mRS), a scale ranging from 0 (no symptoms) to 6 (death), is a precise and effective tool to assess the functional outcome of patients.
次要结局
未报告次要终点
研究者
Xiaolin Chen, MD
Early Blood Pressure Intervention after Coiling or Clipping for Aneurysmal Subarachnoid Hemorrhage
Beijing Tiantan Hospital