Long-term Prognosis of Emergency Aneurysmal Subarachnoid Hemorrhage
ConditionAneurysmal Subarachnoid Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBeijing Tiantan Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
All patients admitted to the emergency department of the investigator with aneurysmal subarachnoid hemorrhage are included in their prospective registry.
Disqualifiers
None
Trial population
All patients admitted to the emergency department of the investigator with aneurysmal subarachnoid hemorrhage are included in their prospective registry
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Surgical clipping and endovascular coiling
Procedure/SurgerySurgical 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.
Treatment groups
5,000 Participants
are divided into 2 treatment groupsGroup A: Surgical clipping1 intervention
Group B: Endovascular coiling1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 days after the procedure2
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.
Time frame
3 months3
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.
Time frame
6 months4
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.
Time frame
12 monthsSecondary outcomes
1
Cognitive deficits
Number of patients experiencing a unfavorable neurological outcome at discharge,defined as changes in thinking, emotion, will and behavior.
Time frame
10 days after the procedure2
Cognitive deficits
Number of patients experiencing a unfavorable neurological outcome at 3 months, defined as changes in thinking, emotion, will and behavior.
Time frame
3 months3
Cognitive deficits
Number of patients experiencing a unfavorable neurological outcome at 6 months, defined as changes in thinking, emotion, will and behavior.
Time frame
6 months4
Cognitive deficits
Number of patients experiencing a unfavorable neurological outcome at 12 months, defined as changes in thinking, emotion, will and behavior.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Tiantan Hospital
Lead sponsor
Peking University International Hospital
Collaborator
Source ClinicalTrials.gov