Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

— LongTEAM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785976
• Other study ID #: KY 2020-11-26
• Status: Recruiting
• Start date: April 1, 2012
• Est. completion date: April 1, 2032

Study information

• Verified date: November 2023
• Source: Beijing Tiantan Hospital
• Contact: Runting Li, MD
• Phone: +8615753166690
• Email: 1011168227[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: April 1, 2032
• Est. primary completion date: March 1, 2032
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Emergencies
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	The First People's Hospital of Neijiang	Neijiang	Sichuan

Sponsors (2)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital	Peking University International Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 3 months, defined as changes in thinking, emotion, will and behavior.	3 months
Secondary	Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 6 months, defined as changes in thinking, emotion, will and behavior.	6 months
Secondary	Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 12 months, defined as changes in thinking, emotion, will and behavior.	12 months
Secondary	Cognitive deficits	Number of patients experiencing a unfavorable neurological outcome at 24 months, defined as changes in thinking, emotion, will and behavior.	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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