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Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

2026年8月24日 更新者:Alex Hall、Emory University

A Prospective, Multicenter, Global Registry Evaluating Minimally Invasive Surgery for the Treatment of Acute Spontaneous Supratentorial Intracerebral Hemorrhage.

The goal of this observational study is to quantify the real-world effect of minimally invasive surgery (MIS) in patients with acute spontaneous supratentorial intracerebral hemorrhage.

研究概览

地位

招聘中

条件

详细说明

Intracerebral hemorrhage (ICH) is one of the most severe forms of stroke, accounting for nearly one-third of all strokes worldwide and affecting more than 3 million people annually. It remains associated with high mortality-over 40% of patients die within 30 days-and significant long-term disability among survivors. Basal ganglia hemorrhage is the most common location of spontaneous ICH and often results in profound neurological deficits, including weakness, sensory loss, visual impairment, and cognitive or speech difficulties. In the United States, more than 80,000 patients each year experience an acute ICH, and the condition contributes substantially to years of life lost, particularly among adults aged 35-65.

Despite decades of research, treatment options for ICH remain limited. Standard medical management focuses on blood pressure control, reversal of coagulopathy, prevention of hematoma expansion, and management of intracranial pressure. Traditional open craniotomy has not consistently improved functional outcomes and carries risks such as infection, rebleeding, and prolonged recovery. As a result, interest has grown in minimally invasive surgical (MIS) techniques designed to remove the hematoma while minimizing damage to surrounding brain tissue.

Over the past two decades, several MIS approaches have been developed, including catheter-based aspiration with thrombolytics, neuroendoscopic evacuation, minimally invasive puncture and drainage, and navigated trans-sulcal parafascicular surgery using tubular retractors. These techniques aim to reduce surgical trauma, improve hematoma evacuation, and limit secondary brain injury caused by inflammation, oxidative stress, and perihematomal edema.

Recent randomized trials have provided important insights into the potential benefits of MIS. The MISTIE III trial demonstrated procedural safety and suggested improved outcomes in patients who achieved substantial hematoma reduction. The ENRICH trial showed that early minimally invasive parafascicular surgery improved functional outcomes at 180 days for patients with lobar ICH and reduced mortality, ICU stay, and serious adverse events. Other trials, including MIND and SWITCH, have contributed additional data on safety, short-term disability, and the potential role of MIS in deep hemorrhages. Updated guidelines from the European Stroke Organization and the American Heart Association now support consideration of MIS for selected patients with supratentorial ICH.

Although evidence is growing, real-world practice varies widely due to differences in patient selection, surgical expertise, device availability, and institutional protocols. Randomized trials often include highly selected populations, limiting generalizability. There is a need for large-scale, prospective, real-world data to better understand how MIS is used across diverse clinical settings and to identify which patients benefit most.

The Rapid Evacuation and Access of Cerebral Hemorrhage (REACH) Registry is designed to address these gaps by prospectively collecting standardized data on patients undergoing MIS evacuation for spontaneous supratentorial ICH. The registry will capture patient demographics, comorbidities, hematoma characteristics, surgical techniques, timing of intervention, degree of hematoma evacuation, and clinical outcomes including mortality, complications, and functional status. By aggregating real-world data across multiple centers, the registry aims to evaluate the safety and effectiveness of different MIS approaches, identify predictors of favorable recovery, and support ongoing improvements in clinical practice.

Ultimately, the REACH Registry seeks to advance evidence-based care for patients with ICH, inform future clinical trials, and contribute to the refinement of national and international treatment guidelines

研究类型

观察性的

注册 (估计的)

2500

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

    • Georgia
      • Atlanta、Georgia、美国、30303
        • 招聘中
        • Grady Memorial Hospital
        • 首席研究员:
          • Jonathan Ratcliff, MD, MPH
        • 接触:
          • Alex Hall, DHSc, MS
        • 首席研究员:
          • Alex Hall, DHSc, MS

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

描述

Inclusion Criteria:

  • Head CT demonstrating an acute, spontaneous, intracerebral hemorrhage
  • Hemorrhage volume ≥ 20 mLs
  • Minimally invasive surgical intervention performed within 7 days of hemorrhage

Exclusion Criteria:

  • Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, moyamoya disease, venous sinus thrombosis, mass or tumor, hemorrhagic conversion of an ischemic infarct, recurrence of a recent ICH (<1 year), as diagnosed with radiographic imaging
  • Infratentorial intraparenchymal hemorrhage, including midbrain, pontine, or cerebellum
  • Initial hospital arrival ≥ 24 hours after the onset of stroke symptoms
  • Last known normal is unknown
  • Historical Modified Rankin Score > 4
  • Known life-expectancy of less than 1 year prior to ICH
  • DNR or comfort measures only
  • Known pregnancy in female subjects
  • Inability or unwillingness of subject or legal guardian/representative to give written informed consent within 7 days of initial hospital arrival
  • Inability to meet follow up requiremen

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Minimally Invasive Surgical Groups
  • Surgical A: Endport evacuation (i.e., MIPS via BrainPath or similar device)
  • Surgical B: Endoscopic evacuation
  • Surgical C: Catheter-based evacuation
  • Surgical D: Other minimally invasive surgical techniques involving clot evacuation
Control Group

No minimally invasive surgical hematoma evacuation performed; n=300 total, capped across 20 sites; may include patients undergoing decompressive hemicraniectomy or other standard medical/surgical approaches):

  • Basal Ganglia Controls (>50% IVH or ICH volume ≥80 mL; n=100)
  • Lobar Controls (ICH volume ≥80 mL; n=100)
  • Primary Thalamic Controls (n=100)
  • ENRICH Trial Controls (ABG and lobar locations; n=150)
  • REACH Trial Controls (ABG location; n=maximum 300)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Modified Rankin Scale (mRS) at 180 Days
大体时间:Day 180 from baseline (±14 days)

Functional outcome will be assessed using the modified Rankin Scale (mRS), a 7-level ordinal scale ranging from 0 (no symptoms) to 6 (death). The primary endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH.

Structured interview performed in person or via telephone by trained study personnel; audio-recorded and centrally adjudicated.

Day 180 from baseline (±14 days)
30-Day Mortality
大体时间:Day 30 (±7 days)
All-cause mortality within 30 days of the initial hemorrhage.
Day 30 (±7 days)

其他结果措施

结果测量
措施说明
大体时间
modified Rankin Scale (mRS) at Additional Time Points
大体时间:Day 7, 30, 90, 180, 365
The endpoint evaluates real-world functional recovery following minimally invasive surgery (MIS) for acute supratentorial ICH. Collected over phone or in-person via structured interview.
Day 7, 30, 90, 180, 365
Post-Operative Infection or CSF Leak
大体时间:Baseline through Day 365
Incidence of surgical site infection or cerebrospinal fluid leak.
Baseline through Day 365
Quality of Life (EQ-5D-5L)
大体时间:Day 7, 30, 90, 180, 365

The EQ-5D-5L assesses health status across five dimensions:

  • Mobility
  • Self-care
  • Usual activities
  • Pain/discomfort
  • Anxiety/depression

Each dimension has five levels (no problems, slight problems, moderate problems, severe problems, extreme problems), allowing patients to describe their health using a five-digit health state (e.g., 11223).

Patients also complete a Visual Analogue Scale (VAS) rating their overall health from 0 (worst imaginable) to 100 (best imaginable)

Day 7, 30, 90, 180, 365
Follow-Up Neuroimaging (24-Hour)
大体时间:Within 24 hours post-procedure
Assessment of hematoma evacuation effectiveness and residual volume.
Within 24 hours post-procedure
In-Hospital Mortality
大体时间:From date of enrollment through the date of hospital discharge (upto 14 days)
All-cause mortality occurring during the initial hospitalization.
From date of enrollment through the date of hospital discharge (upto 14 days)
Change in Hematoma Volume
大体时间:Baseline to follow-up imaging (within first 10 days)
Difference between initial hematoma volume and follow-up neuroimaging volume, assessed centrally by the Neuroimaging Core Lab.
Baseline to follow-up imaging (within first 10 days)
Post-Operative Rebleeding With Neurologic Deterioration (Surgery Group Only)
大体时间:Baseline through Day 10
Rebleeding is defined as hematoma growth on follow-up imaging accompanied by neurologic decline (National Institute of Health Stroke Scale (NIHSS) increase ≥4 or Glasgow Coma Score (GCS) decrease ≤2)
Baseline through Day 10
Time to Intervention
大体时间:From time of enrollment through the time of procedure (upto 100 days)
Time from ictus (symptom onset) to MIS procedure.
From time of enrollment through the time of procedure (upto 100 days)
Surgical Complications
大体时间:Baseline through Day 365
Any intraoperative or postoperative complication related to Minimally invasive surgery (MIS) technique, including device-related events.
Baseline through Day 365
Residual Post-Operative Hemorrhage Volume
大体时间:Post-operative imaging (≤10 days)
Quantification of remaining hematoma volume after MIS.
Post-operative imaging (≤10 days)
Serious Adverse Events (SAEs)
大体时间:Baseline through Day 365
SAEs include events resulting in death, life-threatening conditions, hospitalization, disability, or events requiring medical/surgical intervention.
Baseline through Day 365
Hospital Length of Stay
大体时间:From date of enrollment to the date of discharge (upto 4 weeks or more)
Total number of days from hospital admission to discharge.
From date of enrollment to the date of discharge (upto 4 weeks or more)
Decompressive Hemicraniectomy
大体时间:Baseline through discharge (upto 100 days or more)
Receipt of decompressive hemicraniectomy during the initial hospitalization.
Baseline through discharge (upto 100 days or more)
ICU Length of Stay
大体时间:From date of enrollment to the date of ICU discharge (upto 100 days or more)
Number of days from ICU admission to ICU discharge.
From date of enrollment to the date of ICU discharge (upto 100 days or more)
Duration of Mechanical Ventilation
大体时间:Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)
Total duration of mechanical ventilation during the initial hospitalization.
Time from enrollment to the time mechanical ventilation was stopped (upto 100 days or more)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Alex Hall, DHSc、Emory University
  • 首席研究员:Gustavo Pradilla, MD、Emory University
  • 首席研究员:Jonathan Ratcliff,, MD, MPH、Emory University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年8月12日

初级完成 (估计的)

2033年6月1日

研究完成 (估计的)

2033年6月1日

研究注册日期

首次提交

2026年5月23日

首先提交符合 QC 标准的

2026年6月11日

首次发布 (实际的)

2026年6月16日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

Data will be shared for special requests. REACH Trial must have the primary paper published, and the first 3 papers from the registry must be complete before the data becomes available for sharing.

IPD 共享访问标准

Request to REACH Registry Executive Committee and/or REACH Registry Publications and Data Management Committee (PDMC)

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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