뇌내출혈에 대한 임상 시험 - 임상 시험 레지스트리

연구 개요

상태

모병

정황

뇌내출혈

상세 설명

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

연구 유형

관찰

등록 (추정된)

2500

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

이름: Alex Hall, DHSc
전화번호: 404-778-1585
이메일: alex.hall@emory.edu

연구 장소

미국
- Georgia
  - Atlanta, Georgia, 미국, 30303
    - 모병
    - Grady Memorial Hospital
    - 수석 연구원:
      
      Jonathan Ratcliff, MD, MPH
    - 연락하다:
      
      Alex Hall, DHSc, MS
    - 수석 연구원:
      
      Alex Hall, DHSc, MS

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

성인
고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

비확률 샘플

연구 인구

Subjects with acute, spontaneous supratentorial intracerebral hemorrhage.

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트 그룹/코호트 생물 의학 또는 건강 결과에 대해 평가되는 관찰 연구의 참가자 그룹 또는 하위 그룹입니다.
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)

그룹/코호트

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)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정	측정값 설명	기간
Modified Rankin Scale (mRS) at 180 Days 기간: 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 기간: Day 30 (±7 days)	All-cause mortality within 30 days of the initial hemorrhage.	Day 30 (±7 days)

기타 결과 측정

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Emory University

협력자

The Marcus Foundation

수사관

수석 연구원: Alex Hall, DHSc, Emory University
수석 연구원: Gustavo Pradilla, MD, Emory University
수석 연구원: Jonathan Ratcliff,, MD, MPH, Emory University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 8월 12일

기본 완료 (추정된)

2033년 6월 1일

연구 완료 (추정된)

2033년 6월 1일

연구 등록 날짜

최초 제출

2026년 5월 23일

QC 기준을 충족하는 최초 제출

2026년 6월 11일

처음 게시됨 (실제)

2026년 6월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 26일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 24일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

2026P000373

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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 공유 액세스 기준

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

IPD 공유 지원 정보 유형

연구_프로토콜
수액
ANALYTIC_CODE

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

결과 측정	측정값 설명	기간
modified Rankin Scale (mRS) at Additional Time Points 기간: 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 기간: Baseline through Day 365	Incidence of surgical site infection or cerebrospinal fluid leak.	Baseline through Day 365
Quality of Life (EQ-5D-5L) 기간: 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) 기간: Within 24 hours post-procedure	Assessment of hematoma evacuation effectiveness and residual volume.	Within 24 hours post-procedure
In-Hospital Mortality 기간: 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 기간: 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) 기간: 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 기간: 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 기간: 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 기간: Post-operative imaging (≤10 days)	Quantification of remaining hematoma volume after MIS.	Post-operative imaging (≤10 days)
Serious Adverse Events (SAEs) 기간: 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 기간: 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 기간: 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 기간: 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 기간: 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)

Rapid Evacuation and Access of Cerebral Hemorrhage Registry (REACH)

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