Clinical trial NCT04785976: Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage
Official title: Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage: an MDT- Based Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
Collaborators: name: Peking University International Hospital
First posted: 2021-03-08
Enrollment: 5000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Unfavorable neurological outcome (mRS>2)
timeFrame: 10 days after the procedure
measure: Unfavorable neurological outcome (mRS>2)
timeFrame: 3 months
measure: Unfavorable neurological outcome (mRS>2)
timeFrame: 6 months
measure: Unfavorable neurological outcome (mRS>2)
timeFrame: 12 months
measure: Unfavorable neurological outcome (mRS>2)
timeFrame: 24 months
Secondary outcomes:
measure: Cognitive deficits
timeFrame: 10 days after the procedure
measure: Cognitive deficits
timeFrame: 3 months
measure: Cognitive deficits
timeFrame: 6 months
measure: Cognitive deficits
timeFrame: 12 months
measure: Cognitive deficits
timeFrame: 24 months
measure: Major adverse cardiac or cerebrovascular events
timeFrame: 10 days after the procedure
measure: Major adverse cardiac or cerebrovascular events
timeFrame: 3 months
measure: Major adverse cardiac or cerebrovascular events
timeFrame: 6 months
measure: Major adverse cardiac or cerebrovascular events
timeFrame: 12 months
measure: Major adverse cardiac or cerebrovascular events
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Neijiang
country: China
facility: The First People's Hospital of Neijiang
state: Sichuan
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fa Lin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Yuanli Zhao, MD
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Jizong Zhao, MD
role: STUDY_CHAIR
affiliation: Beijing Tiantan Hospital
name: Runting Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Xiaolin Chen, MD
role: STUDY_DIRECTOR
affiliation: Beijing Tiantan Hospital
name: Yu Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Junlin Lu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Zhipeng Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Heze Han, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Debin Yan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Tiantan Hospital
name: Shuo Wang, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.