Early Surgical Bundle for Intracerebral Hemorrhage (EAGLE) Domain of the APEX-STROKE Adaptive Platform Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 878
- 主要终点
- Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
研究概览
简要总结
In this domain of APEX-STROKE, participants with acute spontaneous supratentorial intracerebral haemorrhage (ICH) who meet the domain-specific eligibility criteria will be randomised to either an early surgical bundle or guideline-based standard care. Intervention: Early minimally invasive surgery (MIS) shall be initiated within 8 hours of symptom onset; intensive systolic blood pressure control (target range: 130-140 mmHg) shall be achieved within 1 hour post-randomization and maintained for 72 hours post-randomization; tranexamic acid (TXA) hemostatic therapy: A 1-g loading dose shall be intravenously infused over 10 minutes, followed by an 8-hour continuous intravenous infusion of a 1-g maintenance dose; the entire regimen must be initiated within 30 minutes post-randomization. Control condition: All patient management shall strictly adhere to local institutional guidelines for intracerebral hemorrhage (ICH) diagnosis and treatment; MIS is recommended to be prohibited within 12 hours of symptom onset (except for emergency life-saving surgery); blood pressure management shall be conducted in accordance with local guidelines; the use of TXA is not recommended.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Confirmed diagnosis of spontaneous supratentorial intracerebral hemorrhage (ICH) via cerebral imaging;
- •Randomization completed within 6 hours of symptom onset (or last known normal state), with the ability to initiate MIS within 8 hours of ICH onset;
- •Hematoma volume ranging from 20 to 80 mL;
- •National Institutes of Health Stroke Scale (NIHSS) score ≥ 8;
- •Glasgow Coma Scale (GCS) score ≥ 8;
- •Provision of written informed consent (or signed by an authorized representative).
排除标准
- •Secondary causes of hemorrhage (e.g., structural abnormalities including arteriovenous malformations, cerebral aneurysms, tumors, trauma) or hemorrhagic transformation of acute ischemic stroke;
- •Isolated intraventricular hemorrhage, or brainstem/cerebellar hemorrhage;
- •Severe chronic kidney disease or liver failure;
- •High risk of mortality within 7 days, or poor adherence to study treatment or follow-up;
- •Severe comorbidities (e.g., cancer, chronic obstructive pulmonary disease, heart failure, significant pre-stroke disability [modified Rankin Scale (mRS) score 3-5]) that may confound outcome assessment;
- •Other conditions judged by the investigator to be unsuitable for MIS (e.g., brain herniation, etc.);
- •Definite indications or contraindications for antihypertensive therapy of different intensities;
- •Specific contraindications to any component of the planned antihypertensive medications (e.g., patients with allergy or hypersensitivity to any ingredient);
- •Patients with contraindications to tranexamic acid (TXA), including: those allergic or hypersensitive to TXA or its excipients, patients with active thrombotic disorders, individuals with hereditary or acquired thrombophilia, patients with subarachnoid hemorrhage, and those with upper urinary tract bleeding complicated by gross hematuria, etc.;
- •Patients known at enrollment to be receiving therapeutic anticoagulation with warfarin or low-molecular-weight heparin (users of direct oral anticoagulants are eligible for inclusion and not excluded).
结局指标
主要结局
Utility-Weighted Modified Rankin Scale (UW-mRS) Score at 6 Months
时间窗: 180 days
Functional outcome will be assessed using the utility-weighted modified Rankin Scale (UW-mRS) by a trained central assessor blinded to treatment allocation. The UW-mRS incorporates the functional health states represented by the modified Rankin Scale into a utility-weighted measure of overall functional outcome.
次要结局
- National Institutes of Health Stroke Scale (NIHSS) Score(24 hours after randomization, 7 days after randomization or earlier at hospital discharge)
- Rebleeding(Within 7 days after randomization or earlier at hospital discharge)
- Poor Functional Outcome(180 days)
- Mortality(180 days)
- Disability(180 days)
- Health-Related Quality of Life Assessed by EQ-5D-5L(180 days)