두개내압 모니터링을 기반으로 한 동맥류 지주막하 출혈 치료 (ASTIM)
두개내압 모니터링을 기반으로 한 동맥류 지주막하 출혈 치료: 다기관, 무작위, 대조 연구
ASTIM is a multicenter, prospective, randomised, blinded end-point assessed trial, to investigate the efficacy and safety of treatment based on intracranial pressure monitoring in improving the prognosis of patients with aneurysmal subarachnoid hemorrhage.
연구 개요
상태
상세 설명
Subarachnoid hemorrhage (SAH) is a severe type of cerebral hemorrhage, characterized by high mortality and disability rates. Approximately 85% of SAH cases are caused by ruptured intracranial aneurysms and are classified as aneurysmal SAH (aSAH). Improving the prognosis of patients with aSAH has become a pressing and significant issue.
The rupture of an aneurysm results in a significant amount of blood entering the subarachnoid space, triggering an increase in intracranial pressure (ICP). Elevated ICP can impair cerebral perfusion and contribute to secondary brain injury and poor functional outcomes. A systematic review and meta-analysis found that the incidence rate of elevated ICP (ICP >20 mmHg) in patients with aSAH was 70.69%, with elevated ICP being more common in patients with higher disease severity grades, including higher Hunt-Hess, WFNS, or modified Fisher grades.
Intraventricular ICP monitoring provides continuous, real-time quantitative ICP data and may facilitate a stepwise ICP-lowering strategy and goal-directed management based on quantitative ICP values. However, the role of continuous ICP monitoring and protocolized ICP-targeted management in aSAH remains uncertain, and high-quality randomized evidence remains limited. Given this evidence gap, this study was designed to determine whether a structured management strategy guided by continuous intraventricular ICP monitoring improves functional outcomes in patients with aSAH compared with standard care, and to assess the safety of this management strategy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Shanghai Municipality
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Shanghai, Shanghai Municipality, 중국, 200000
- Department of Neurosurgery, Huashan Hospital, Fudan University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criterias
- Definite diagnosis of aSAH: presence of SAH symptoms confirmed by CT, with rupture of an intracranial aneurysm identified by CTA or DSA. The ruptured aneurysm is scheduled for definitive treatment (clipping or endovascular therapy) within 72 hours of onset.
- Age ≥ 18 years.
- Symptom onset within 72 hours.
- Hunt-Hess grade 2-4 and modified Fisher grade 2-4 on CT imaging.
- Written informed consent obtained from the participant or legal representative.
Exclusion criteria included
- Pregnancy or lactation;
- Bilateral fixed dilated pupils on admission;
- Malignancy, bleeding disorders, or other severe systemic comorbidities, including chronic obstructive pulmonary disease, multiple organ dysfunction, severe diabetes, heart failure, or chronic kidney disease;
- Pre-existing neurological disability due to previous brain disease or neurosurgery, defined as a premorbid modified Rankin Scale (mRS) score ≥3;
- Significant structural abnormalities on neuroimaging, such as extensive encephalomalacia or marked mass effect;
- Subarachnoid haemorrhage caused by non-aneurysmal aetiologies;
- Moyamoya disease associated aneurysmal rupture;
- Other underlying diseases expected to substantially affect prognosis;
- Active request for ICP monitoring by the patient or family;
- Any other condition considered unsuitable for enrolment by two investigators;
- Concurrent participation in another clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: aSAH management guided by continuous intraventricular ICP monitoring
In the acute phase of aSAH (following endovascular or microsurgical occlusion of the ruptured aneurysm), an intraventricular ICP catheter is placed for continuous ICP monitoring. Postoperative ICP management is guided by continuous quantitative ICP measurements according to a predefined ICP-targeted treatment protocol. Other guideline-based treatments are provided in the same manner as in the control group. |
The postoperative management of ICP is guided by continuous quantitative intraventricular ICP measurements according to a predefined ICP-targeted treatment protocol. The treatment target is ICP ≤20 mmHg, and a predefined stepwise ICP-lowering protocol is initiated if ICP remains >20 mmHg for more than 15 minutes. CSF drainage through the intraventricular catheter is permitted when clinically indicated. Other guideline-based treatments are provided in the same manner as in the control group. |
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간섭 없음: Guideline-based Standard Care Group
Guideline-based standard aSAH management is provided without continuous intraventricular ICP monitoring or the predefined ICP-targeted treatment protocol. ICP-related management is not guided by continuous quantitative ICP measurements and is instead based on clinical assessment, imaging findings, and treating physician judgment. Clinically indicated CSF diversion and other standard ICP-lowering treatments are permitted. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Favourable functional outcome at 3 months
기간: 3 months after ictus
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The proportion of patients with modified Rankin Scale (mRS) scores of 0-2. The mRS is an ordinal scale ranging from 0 to 6, with higher scores indicating greater disability. An mRS score of 0-2 is defined as a favourable functional outcome. |
3 months after ictus
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Favourable functional outcome assessed by mRS
기간: 1 month and 6 months after ictus
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Proportion of patients with mRS scores 0-2 |
1 month and 6 months after ictus
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Favourable functional outcome assessed by Glasgow Outcome Scale-Extended (GOS-E)
기간: 1 month, 3 months, and 6 months after ictus
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The GOS-E is an ordinal scale ranging from 1 to 8, with lower scores indicating greater disability. A GOS-E score ≥5 is defined as a favourable functional outcome. |
1 month, 3 months, and 6 months after ictus
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All-cause mortality
기간: 1 month, 3 months, and 6 months after ictus
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Proportion of patients who died. |
1 month, 3 months, and 6 months after ictus
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Symptomatic hydrocephalus requiring permanent CSF shunting
기간: 3 months after ictus
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Proportion of patients with symptomatic hydrocephalus requiring ventriculoperitoneal or lumboperitoneal shunt placement. |
3 months after ictus
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Delayed cerebral ischemia (DCI)
기간: 3 months after ictus
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Proportion of patients with DCI. DCI is defined according to the consensus criteria proposed by Vergouwen et al. Clinical DCI is defined as a new focal neurological impairment or a decrease of at least 2 points on the GCS, lasting for at least 1 hour, not apparent immediately after aneurysm occlusion, and not attributable to other causes. DCI-related cerebral infarction is defined as a new cerebral infarction identified on CT or MRI within 6 weeks after SAH that was absent on imaging obtained 24-48 hours after aneurysm occlusion and cannot be attributed to other causes. |
3 months after ictus
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New-onset seizures
기간: 3 months after ictus
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Proportion of patients with clinically or electroencephalographically confirmed new-onset seizures. |
3 months after ictus
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Rebleeding
기간: 3 months
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New subarachnoid, intracerebral, or intraventricular haemorrhage attributable to rerupture of the index aneurysm after randomisation, confirmed by neuroimaging. |
3 months
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Catheter tract haemorrhage
기간: 3 months
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New intraparenchymal or intraventricular haemorrhage along the trajectory of an intraventricular ICP monitoring catheter or EVD after catheter placement or removal, confirmed by CT, with an estimated haemorrhage volume ≥5 mL. |
3 months
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Intracranial infection
기간: 3 months
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Intracranial infection meeting the prespecified microbiological and/or clinical cerebrospinal fluid criteria, with suspected events adjudicated according to the prespecified definition. |
3 months
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Wound-related complications
기간: 3 months
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Infection, dehiscence, cerebrospinal fluid leakage, or other clinically significant wound complication at the ICP monitoring catheter or EVD insertion site requiring resuturing, procedural intervention, or prolonged wound care. |
3 months
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Serious adverse events (SAEs)
기간: 6 months
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All serious adverse events are systematically recorded through completion of the 6-month follow-up. |
6 months
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Wei Zhu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
- 수석 연구원: Xuehai Wu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
간행물 및 유용한 링크
일반 간행물
- Vergouwen MD, Vermeulen M, van Gijn J, Rinkel GJ, Wijdicks EF, Muizelaar JP, Mendelow AD, Juvela S, Yonas H, Terbrugge KG, Macdonald RL, Diringer MN, Broderick JP, Dreier JP, Roos YB. Definition of delayed cerebral ischemia after aneurysmal subarachnoid hemorrhage as an outcome event in clinical trials and observational studies: proposal of a multidisciplinary research group. Stroke. 2010 Oct;41(10):2391-5. doi: 10.1161/STROKEAHA.110.589275. Epub 2010 Aug 26.
- Macdonald RL, Schweizer TA. Spontaneous subarachnoid haemorrhage. Lancet. 2017 Feb 11;389(10069):655-666. doi: 10.1016/S0140-6736(16)30668-7. Epub 2016 Sep 13.
- Etminan N, Chang HS, Hackenberg K, de Rooij NK, Vergouwen MDI, Rinkel GJE, Algra A. Worldwide Incidence of Aneurysmal Subarachnoid Hemorrhage According to Region, Time Period, Blood Pressure, and Smoking Prevalence in the Population: A Systematic Review and Meta-analysis. JAMA Neurol. 2019 May 1;76(5):588-597. doi: 10.1001/jamaneurol.2019.0006.
- Neifert SN, Chapman EK, Martini ML, Shuman WH, Schupper AJ, Oermann EK, Mocco J, Macdonald RL. Aneurysmal Subarachnoid Hemorrhage: the Last Decade. Transl Stroke Res. 2021 Jun;12(3):428-446. doi: 10.1007/s12975-020-00867-0. Epub 2020 Oct 19.
- Ironside N, Buell TJ, Chen CJ, Kumar JS, Paisan GM, Sokolowski JD, Liu KC, Ding D. High-Grade Aneurysmal Subarachnoid Hemorrhage: Predictors of Functional Outcome. World Neurosurg. 2019 May;125:e723-e728. doi: 10.1016/j.wneu.2019.01.162. Epub 2019 Feb 6.
- Seule M, Oswald D, Muroi C, Brandi G, Keller E. Outcome, Return to Work and Health-Related Costs After Aneurysmal Subarachnoid Hemorrhage. Neurocrit Care. 2020 Aug;33(1):49-57. doi: 10.1007/s12028-019-00905-2.
- Heuer GG, Smith MJ, Elliott JP, Winn HR, LeRoux PD. Relationship between intracranial pressure and other clinical variables in patients with aneurysmal subarachnoid hemorrhage. J Neurosurg. 2004 Sep;101(3):408-16. doi: 10.3171/jns.2004.101.3.0408.
- Robba C, Graziano F, Rebora P, Elli F, Giussani C, Oddo M, Meyfroidt G, Helbok R, Taccone FS, Prisco L, Vincent JL, Suarez JI, Stocchetti N, Citerio G; SYNAPSE-ICU Investigators. Intracranial pressure monitoring in patients with acute brain injury in the intensive care unit (SYNAPSE-ICU): an international, prospective observational cohort study. Lancet Neurol. 2021 Jul;20(7):548-558. doi: 10.1016/S1474-4422(21)00138-1.
- Hoh BL, Ko NU, Amin-Hanjani S, Chou SH-Y, Cruz-Flores S, Dangayach NS, Derdeyn CP, Du R, Hanggi D, Hetts SW, Ifejika NL, Johnson R, Keigher KM, Leslie-Mazwi TM, Lucke-Wold B, Rabinstein AA, Robicsek SA, Stapleton CJ, Suarez JI, Tjoumakaris SI, Welch BG. 2023 Guideline for the Management of Patients With Aneurysmal Subarachnoid Hemorrhage: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2023 Jul;54(7):e314-e370. doi: 10.1161/STR.0000000000000436. Epub 2023 May 22.
- Claassen J, Park S. Spontaneous subarachnoid haemorrhage. Lancet. 2022 Sep 10;400(10355):846-862. doi: 10.1016/S0140-6736(22)00938-2. Epub 2022 Aug 16.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- KY2024-050
개별 참가자 데이터(IPD) 계획
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