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NCT Number: NCT04785976

Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Tiantan Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical clipping and endovascular coiling

Procedure

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.

Primary outcomes

  1. Unfavorable neurological outcome (mRS>2)

    Time frame: 10 days after the procedure

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

  2. Unfavorable neurological outcome (mRS>2)

    Time frame: 3 months

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

  3. Unfavorable neurological outcome (mRS>2)

    Time frame: 6 months

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

  4. Unfavorable neurological outcome (mRS>2)

    Time frame: 12 months

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

  5. Unfavorable neurological outcome (mRS>2)

    Time frame: 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 outcomes

  1. Cognitive deficits

    Time frame: 10 days after the procedure

    Number of patients experiencing a unfavorable neurological outcome at discharge,defined as changes in thinking, emotion, will and behavior.

  2. Cognitive deficits

    Time frame: 3 months

    Number of patients experiencing a unfavorable neurological outcome at 3 months, defined as changes in thinking, emotion, will and behavior.

  3. Cognitive deficits

    Time frame: 6 months

    Number of patients experiencing a unfavorable neurological outcome at 6 months, defined as changes in thinking, emotion, will and behavior.

  4. Cognitive deficits

    Time frame: 12 months

    Number of patients experiencing a unfavorable neurological outcome at 12 months, defined as changes in thinking, emotion, will and behavior.

  5. Cognitive deficits

    Time frame: 24 months

    Number of patients experiencing a unfavorable neurological outcome at 24 months, defined as changes in thinking, emotion, will and behavior.

  6. Major adverse cardiac or cerebrovascular events

    Time frame: 10 days after the procedure

    Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at discharge.

  7. Major adverse cardiac or cerebrovascular events

    Time frame: 3 months

    Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 3 months.

  8. Major adverse cardiac or cerebrovascular events

    Time frame: 6 months

    Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 6 months.

  9. Major adverse cardiac or cerebrovascular events

    Time frame: 12 months

    Number of patients experiencing an event including all-cause death, non-fatal cerebrovascular event, non-fatal any myocardial infarction and revascularization at 12 months.

  10. Major adverse cardiac or cerebrovascular events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Runting Li, MD

CONTACT

[email protected]

+8615753166690 ext. +8613681107240

Xiaolin Chen, MD

CONTACT

[email protected]

+8613810624845 ext. +8615753166690

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Collaborators

  • Peking University International Hospital

Registry information

Official study title

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

Acronym: LongTEAM

Important dates

Study start
2012
Primary completion
2032
Study completion
2032
First posted
Mar 8, 2021
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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