Maximal Medical Treatment of Intracerebral Haemorrhage Pilot Trial - MAX-ICH Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
The MAX-ICH pilot trial is a phase-II study aimed at assessing the feasibility and safety of a comprehensive care bundle for patients with intracerebral hemorrhage (ICH). This "maximal medical treatment" approach combines advanced interventions like intensive blood pressure control, rapid anticoagulation reversal, and tranexamic acid administration to potentially improve outcomes. The primary objective is to evaluate recruitment feasibility over 12 months, while secondary objectives include protocol adherence, safety monitoring, and the exploration of clinical outcomes. The study focuses on the critical first 72 hours of care to determine if this approach can be effectively implemented in clinical practice.
详细描述
The MAX-ICH pilot trial is a monocentric, phase-II study designed to evaluate the feasibility and safety of a "maximal medical treatment" care bundle for patients suffering from intracerebral hemorrhage (ICH). ICH is a condition with a notably high rate of mortality and morbidity, and this trial aims to improve outcomes for these patients by utilizing a comprehensive approach to their treatment. Previous clinical trials concentrated on single interventions, such as blood pressure control and the administration of tranexamic acid (TXA) therapy. While these interventions did not achieve their primary efficacy outcomes, they did demonstrate beneficial effects on secondary measures like reducing hematoma expansion and early mortality. The current study builds on this prior research by integrating advanced interventions into a unified and comprehensive care bundle, termed MAX-ICH, with the goal of potentially enhancing patient outcomes.
The primary objective of the trial is to demonstrate the feasibility of recruiting patients within a 12-month period. In addition to this, secondary objectives include assessing the technical feasibility of protocol adherence, targeting a compliance rate of at least 70%. The study will also monitor safety by tracking major adverse cardiovascular events (MACE) and explore a range of clinical outcomes, treatment metrics, and differences between the experimental group receiving the MAX-ICH care bundle and those receiving standard care.
The MAX-ICH care bundle consists of several key components designed to deliver intensive and timely care. Patients will receive 72 hours of treatment in a high-dependency unit, ensuring continuous monitoring and rapid responses to any changes in their condition. Intensive blood pressure control will be implemented through intra-arterial monitoring to maintain stability. If a patient is on anticoagulant therapy, the care bundle mandates rapid reversal of anticoagulation within 60 minutes of presentation. Similarly, tranexamic acid will be administered within 60 minutes, helping to mitigate further hemorrhage. Neurosurgical evaluation will also be conducted within 60 minutes to determine if surgical intervention is warranted. Additionally, counseling will be provided to avoid placing Do-Not-Resuscitate (DNR) orders during the critical first 72 hours, allowing time for the intensive interventions to take effect.
Ultimately, this study aims to determine whether the MAX-ICH care bundle can be feasibly implemented in clinical practice and whether its structured, intensive approach within the first 72 hours of care can lead to improved outcomes for patients with ICH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinded Endpoint Assessment
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic imaging proven diagnosis of non-traumatic ICH
- •Vascular imaging (MR-/CT-angiogram or DSA) on admission to rule out high suspicion of macrovascular bleeding source
- •Enrolment no later than 6 hours of symptom onset
- •Age >18 years, no upper age limit
- •Informed consent as documented by signature or fulfilling the criteria for emergency consent/ deferral consent
排除标准
- •Palliative care/comfort therapy decision in the emergency department
- •ICH due to trauma (major head trauma <24 hours of symptom onset causing loss of consciousness and thought to be sufficient to have caused the intracerebral bleeding)
- •High suspicion of ICH due to arteriovenous malformation (AVM), aneurysm or sinus-venous-thrombosis confirmed by neuroimaging, brain tumor, vasculitis, RCVS/PRES or system disease (liver disease, inherit coagulopathy)
- •Severe ICH (haematoma volume >60ml or GCS <8)
- •Haematoma evacuation or decompressive craniectomy within 72 hours planned or highly likely (isolated EVD is not an exclusion criterion)
- •Severe pre-morbid disability [modified Rankin scale (mRS) is ≥4]
- •Contraindication against the use of tranexamic acid
- •Active participation in another drug or devices trial concurrently
- •Female patient that are either pregnant or breastfeeding
- •Contraindications against Clevidipine (allergy to soja, lipid metabolism defect or known severe aortic stenosis)
研究组 & 干预措施
Control arm (usual care)
Control group is treated according to local standard of care
干预措施: Standard of care (Other)
Experimental arm (MAX-ICH care bundle)
Experimental group is treated according MAX-ICH care bundle
干预措施: MAX-ICH care bundle (Other)
结局指标
主要结局
Recruitment
时间窗: 12 months
Recruitment rate at 12 months
次要结局
- Between group differences(72 hours)
- Radiological outcomes(72 hours)
- Quality of blood pressure control(72 hours)
- Technical feasibility(12 months)
- Major Adverse Cardiovascular Events(30 days)
- Clinical outcomes(6 months)
- Clinical Outcome(6 months)
- Clinical outcomes(3 months)
- Radiological outcomes(24 hours)
- Clinical outcomes(24 hours)
- Clinical Outcome(24 hours)
- Clinical outcomes(72 hours)
- Clinical Outcome(72 hours)
- Clinical Outcome(3 months)
- Quality of blood pressure control(60 min)