Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage

Recruiting

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Procedure: Surgical clipping and endovascular coiling

• Registration Number: NCT04785976
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04-01
• Study First Submitted: 2021-02-01
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2032-03-01
• Study Completion: 2032-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endovascular coiling	Surgical clipping and endovascular coiling	-
Surgical clipping	Surgical clipping and endovascular coiling	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Cognitive deficits	24 months	Number of patients experiencing a unfavorable neurological outcome at 24 months, defined as changes in thinking, emotion, will and behavior.
Major adverse cardiac or cerebrovascular events	24 months	Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 24 months.

Trial Locations

Locations (2)

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

The First People's Hospital of Neijiang; 🇨🇳 Neijiang, Sichuan, China