NCT04785976

Brief Summary

Rupture of intracranial aneurysms can lead to extensive subarachnoid hemorrhage (SAH), a potentially fatal neurological emergency with mortality rates ranging from 8 to 67%. At present, surgical clipping (SC) and endovascular coiling (EC) are two main treatments for aneurysmal subarachnoid hemorrhage (aSAH), in recent years, the improvements in surgical equipment and techniques have already greatly improved the postoperative safety of patients. However, considering individual differences between patients, some still at risk due to possible complications during hospitalization or after discharge from the hospital, it will no doubt generate a large healthcare burden. This prospective, observational clinical trial (LongTEAM) is to improve the diagnosis and treatment effect and efficiency in this field, reducing mortality, medical costs, and medical burden, while opening up new avenues for interdisciplinary clinical practice and scientific research exploration.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
72mo left

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Apr 2012Apr 2032

Study Start

First participant enrolled

April 1, 2012

Completed
8.8 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2032

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2032

Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

19.9 years

First QC Date

February 1, 2021

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Unfavorable neurological outcome (mRS>2)

    Number of patients experiencing a unfavorable neurological outcome at discharge, defined as a modified Rankin Scale (mRS) score of \>2.

    10 days after the procedure

  • Unfavorable neurological outcome (mRS>2)

    Number of patients experiencing a unfavorable neurological outcome at 3 months post-treatment, defined as a modified Rankin Scale (mRS) score of \>2.

    3 months

  • Unfavorable neurological outcome (mRS>2)

    Number of patients experiencing a unfavorable neurological outcome at 6 months post-treatment, defined as a modified Rankin Scale (mRS) score of \>2.

    6 months

  • Unfavorable neurological outcome (mRS>2)

    Number of patients experiencing a unfavorable neurological outcome at 12 months post-treatment, defined as a modified Rankin Scale (mRS) score of \>2.

    12 months

  • Unfavorable neurological outcome (mRS>2)

    Number of patients experiencing a unfavorable neurological outcome at 24 months post-treatment, defined as a modified Rankin Scale (mRS) score of \>2.

    24 months

Secondary Outcomes (10)

  • Cognitive deficits

    10 days after the procedure

  • Cognitive deficits

    3 months

  • Cognitive deficits

    6 months

  • Cognitive deficits

    12 months

  • Cognitive deficits

    24 months

  • +5 more secondary outcomes

Study Arms (2)

Surgical clipping

Procedure: Surgical clipping and endovascular coiling

Endovascular coiling

Procedure: Surgical clipping and endovascular coiling

Interventions

Surgical clipping: Apply aneurysm clip to clip the ruptured aneurysm. Endovascular coiling:Also called endovascular embolization, to block blood flow into an aneurysm.Preventing blood flow into an aneurysm helps to keep it from rupturing.

Endovascular coilingSurgical clipping

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the emergency department of the investigator with aneurysmal subarachnoid hemorrhage are included in their prospective registry

You may qualify if:

  • All patients admitted to the emergency department of the investigator with aneurysmal subarachnoid hemorrhage are included in their prospective registry.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

The First People's Hospital of Neijiang

Neijiang, Sichuan, China

RECRUITING

Related Publications (9)

  • Tang X, Wang X, Zhu B, Zhou L, Chen X. The prognostic significance of uric acid to albumin ratio in patients with aneurysmal subarachnoid hemorrhage following surgical clipping or endovascular interventions: insights from a large cohort study. Front Neurol. 2026 Jan 12;16:1648805. doi: 10.3389/fneur.2025.1648805. eCollection 2025.

  • Yu T, Lau TY, Liu Y, Li R, Lin F, Song Z, Zhu Q, Chen Y, Li T, Jing J, Chen X. Low-Field Portable MRI Detects Developmental Pattern of Ultraearly Cerebral Infarction in aSAH. Stroke. 2025 Dec 11. doi: 10.1161/STROKEAHA.125.052474. Online ahead of print.

  • Tang X, Zhu B, Liu M, Lin F, Li R, Song W, Xue J, Zhou L, Chen X. Increased triglyceride-glucose index is associated with adverse functional outcome for patients with aneurysmal subarachnoid hemorrhage after surgical clipping and endovascular coiling: insights from a large cohort study. Front Neurol. 2025 Sep 10;16:1622819. doi: 10.3389/fneur.2025.1622819. eCollection 2025.

  • Yang Y, Zhu B, Lin F, Li R, Chen X. Association between geriatric nutritional risk index and clinical outcome of elderly aneurysmal subarachnoid hemorrhage patients: insights from a large cohort study. Neurosurg Rev. 2025 Feb 4;48(1):169. doi: 10.1007/s10143-025-03209-6.

  • Li R, Lin F, Chen Y, Lu J, Yang J, Han H, Yuan K, Wang K, Yan D, Li R, He S, Li Z, Zhang H, Chen X, Ma L, Zhao Y, Hao Q, Ye X, Wang H, Li H, Zhang L, Shi G, Zhou J, Li Y, Wang S, Chen X, Zhao Y. The effect of sex differences on complications and 90-day outcomes after aneurysmal subarachnoid hemorrhage: a propensity score-matched analysis. Neurosurg Rev. 2022 Oct;45(5):3339-3347. doi: 10.1007/s10143-022-01836-x. Epub 2022 Jul 23.

  • Li R, Lin F, Chen Y, Lu J, Han H, Ma L, Zhao Y, Yan D, Li R, Yang J, He S, Li Z, Zhang H, Yuan K, Wang K, Hao Q, Ye X, Wang H, Li H, Zhang L, Shi G, Zhou J, Zhao Y, Zhang Y, Li Y, Wang S, Chen X, Zhao Y. A 90-Day Prognostic Model Based on the Early Brain Injury Indicators after Aneurysmal Subarachnoid Hemorrhage: the TAPS Score. Transl Stroke Res. 2023 Apr;14(2):200-210. doi: 10.1007/s12975-022-01033-4. Epub 2022 May 14.

  • Li R, Lin F, Chen Y, Lu J, Han H, Ma L, Zhao Y, Yan D, Li R, Yang J, He S, Li Z, Zhang H, Yuan K, Wang K, Hao Q, Ye X, Wang H, Li H, Zhang L, Shi G, Zhou J, Zhao Y, Zhang Y, Li Y, Wang S, Chen X, Zhao Y. Elevated blood hemoglobin on admission as an independent predictor of unfavorable outcomes in patients with aneurysmal subarachnoid hemorrhage. Neurosurg Rev. 2022 Aug;45(4):2689-2699. doi: 10.1007/s10143-022-01780-w. Epub 2022 Apr 2.

  • Yang J, Lu J, Li R, Lin F, Chen Y, Han H, Yan D, Li R, Li Z, Zhang H, Yuan K, Li H, Zhang L, Shi G, Zhou J, Wang S, Zhao Y, Chen X. Application of Intracranial Pressure-Directed Therapy on Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage. Front Aging Neurosci. 2022 Mar 14;14:831994. doi: 10.3389/fnagi.2022.831994. eCollection 2022.

  • Lin F, Chen Y, He Q, Zeng C, Zhang C, Chen X, Zhao Y, Wang S, Zhao J. Prognostic Value of Elevated Cardiac Troponin I After Aneurysmal Subarachnoid Hemorrhage. Front Neurol. 2021 May 31;12:677961. doi: 10.3389/fneur.2021.677961. eCollection 2021.

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Fa Lin, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Yuanli Zhao, MD

    Beijing Tiantan Hospital

    STUDY CHAIR
  • Jizong Zhao, MD

    Beijing Tiantan Hospital

    STUDY CHAIR
  • Runting Li, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Xiaolin Chen, MD

    Beijing Tiantan Hospital

    STUDY DIRECTOR
  • Yu Chen, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Junlin Lu, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Zhipeng Li, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Heze Han, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Debin Yan, MD

    Beijing Tiantan Hospital

    PRINCIPAL INVESTIGATOR
  • Shuo Wang, MD

    Beijing Tiantan Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Cerebrovascular Neurosurgery

Study Record Dates

First Submitted

February 1, 2021

First Posted

March 8, 2021

Study Start

April 1, 2012

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

April 1, 2032

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
6 months after the study ended
Access Criteria
The IPD of this study are available from the principal investigator upon reasonable request.

Locations