Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage (LongTEAM)

Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage: an MDT- Based Multicenter Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Intervention / Treatment: Procedure: Surgical clipping and endovascular coiling

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Runting Li, MD; Phone Number: +8613681107240 +8615753166690; Email: 1011168227@qq.com
• Study Contact Backup: Name: Xiaolin Chen, MD; Phone Number: +8615753166690 +8613810624845; Email: xiaolinchen488@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100070
      • Recruiting
      • Beijing Tiantan Hospital
      • Contact: Runting Li, MD; Phone Number: +8615753166690; Email: 1011168227@qq.com
      • Contact: Xiaolin Chen, MD; Phone Number: +8613810624845; Email: xiaolinchen488@hotmail.com
  • Sichuan
    • Neijiang, Sichuan, China
      • Recruiting
      • The First People's Hospital of Neijiang
      • Contact: Qian Wu, MD; Email: wsq9385@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Surgical clipping	Procedure: Surgical clipping and endovascular coiling; 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 coiling	Procedure: Surgical clipping and endovascular coiling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at discharge,defined as changes in thinking, emotion, will and behavior.	10 days after the procedure
Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 3 months, defined as changes in thinking, emotion, will and behavior.	3 months
Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 6 months, defined as changes in thinking, emotion, will and behavior.	6 months
Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 12 months, defined as changes in thinking, emotion, will and behavior.	12 months
Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 24 months, defined as changes in thinking, emotion, will and behavior.	24 months
Major adverse cardiac or cerebrovascular events	Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at discharge.	10 days after the procedure
Major adverse cardiac or cerebrovascular events	Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 3 months.	3 months
Major adverse cardiac or cerebrovascular events	Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 6 months.	6 months
Major adverse cardiac or cerebrovascular events	Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 12 months.	12 months
Major adverse cardiac or cerebrovascular events	Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 24 months.	24 months

Collaborators and Investigators

• Sponsor: Beijing Tiantan Hospital
• Collaborators: Peking University International Hospital
• Investigators: Principal Investigator: Yu Chen, MD, Beijing Tiantan Hospital; Principal Investigator: Fa Lin, MD, Beijing Tiantan Hospital; Study Chair: Yuanli Zhao, MD, Beijing Tiantan Hospital; Study Chair: Jizong Zhao, MD, Beijing Tiantan Hospital; Principal Investigator: Runting Li, MD, Beijing Tiantan Hospital; Study Director: Xiaolin 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; Study Chair: Shuo Wang, MD, Beijing Tiantan Hospital

Publications and helpful links

General Publications

• 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. 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2012
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: March 5, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Intracranial Hemorrhages; Emergencies; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: KY 2020-11-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual participant data (IPD) of this study are available from the principal investigator upon reasonable request.
• IPD Sharing Time Frame: 6 months after the study ended
• IPD Sharing Access Criteria: The IPD of this study are available from the principal investigator upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No