Aneurysmal Subarachnoid HemorrhageaSAH-OmicsNCT07270419
Aneurysmal Subarachnoid Hemorrhage Multi-Omics Research Program
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Xiaolin Chen, MD at 1 site in China.
Trial summary
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening cerebrovascular emergency with high mortality and disability rates. Despite advances in neuroimaging and interventional techniques, outcomes remain poor for many patients due to complex post-rupture complications such as delayed cerebral ischemia (DCI)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 1 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients (≥18 years) with aneurysmal subarachnoid hemorrhage (aSAH) confirmed by CTA, or DSA, whose aneurysms are treated by microsurgical clipping or endovascular coiling within 72 hours after onset. Participants will be consecutively recruited from multiple tertiary neurosurgical centers.
Who may be able to join
- Adult patients aged ≥18 years;
- Confirmed diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) by CTA, or DSA;
- Aneurysm secured by either microsurgical clipping or endovascular coiling during hospitalization;
- Time from onset to aneurysm treatment ≤ 72 hours;
- Availability of biospecimens, including blood, cerebrospinal fluid (CSF), urine, or fecal samples collected during hospitalization;
- Signed informed consent obtained from the patient or legal representative.
Who cannot join
- History of previous intracranial aneurysm surgery or embolization;
- Non-aneurysmal SAH, traumatic SAH, or perimesencephalic non-aneurysmal hemorrhage;
- Presence of malignancy, severe hepatic or renal dysfunction, or other systemic diseases that may affect survival or biomarker expression;
- Severe cardiorespiratory insufficiency or unstable medical condition precluding study participation;
- Pregnancy or lactation;
- Refusal to participate or withdrawal of consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Runting Li, MD, +86 15753166690, tt18080lrt@163.com
About this study
Official title: Aneurysmal Subarachnoid Hemorrhage Multi-Omics Research Program (aSAH-Omics) ：A Multicenter Clinical and Mechanistic Study
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening cerebrovascular emergency with high mortality and disability rates. Despite advances in neuroimaging and interventional techniques, outcomes remain poor for many patients due to complex post-rupture complications such as delayed cerebral ischemia (DCI), pneumonia, and other systemic injuries. These secondary events critically affect neurological recovery, yet their molecular mechanisms are not fully understood.
This multicenter study aims to investigate the biological basis of post-rupture complications and prognosis in patients with aSAH through integrated multi-omics and clinical data analysis. Biospecimens including blood, cerebrospinal fluid, urine, and other relevant tissues will be collected for genomic, transcriptomic, proteomic, metabolomic, and imaging-omic profiling. By linking molecular data with clinical and imaging indicators, the study seeks to identify key pathways and biomarkers associated with secondary injury and outcome heterogeneity.
Read the detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is a severe cerebrovascular emergency caused by the rupture of an intracranial aneurysm. Despite advances in neuroimaging and microsurgical or endovascular techniques, aSAH remains associated with high mortality and long-term disability. Post-rupture complications-such as delayed cerebral ischemia (DCI), pneumonia, and other systemic complications-are major determinants of neurological recovery and prognosis.
Following aneurysm rupture, a cascade of complex secondary injuries is triggered, critically influencing clinical outcomes. Beyond the initial hemorrhagic insult, secondary pathophysiological processes-including neuroinflammation, endothelial dysfunction, and blood-brain barrier disruption-play pivotal roles in mediating delayed brain injury and neurological deterioration. However, how these biological processes interact and contribute to heterogeneous outcomes remains poorly understood.
This multicenter study aims to elucidate the molecular mechanisms underlying post-rupture complications and prognosis in aSAH through integrative multi-omics and clinical data analysis. By combining genomic, transcriptomic, proteomic, metabolomic, and imaging-omic approaches using biospecimens such as blood, cerebrospinal fluid, urine, and other relevant tissues, this project seeks to identify key molecular pathways and biomarkers associated with secondary injury and outcome variation. The findings are expected to provide systematic insights into the biological basis of aSAH progression and establish a foundation for precision prediction and individualized management.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Multi-Omics, Prognosis, Complications, Aneurysmal Subarachnoid Hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Scale (mRS) score for functional outcome
Functional outcome will be evaluated using the modified Rankin Scale (mRS), ranging from 0 (no symptoms) to 6 (death). Higher scores indicate greater disability. The distribution of mRS scores will be analyzed at predefined follow-up time points.
Measured: 3, 6, and 12 months after onset
Secondary outcomes (5)
Incidence of rebleeding
Rebleeding is defined as sudden clinical deterioration during postoperative hospitalization, accompanied by evidence of increased bleeding on serial CT scans.
Measured: After onset, up to 30 days
Incidence of delayed cerebral ischemia (DCI)
DCI is defined as new focal neurological deficits or global neurological deterioration (a decrease of ≥2 points on the Glasgow Coma Scale) lasting more than 2 hours, after excluding intracranial hemorrhage, hydrocephalus, seizures, metabolic derangements, and infection, with or without radiological evidence of cerebral vasospasm.
Measured: After onset, up to 30 days
Incidence of anemia
Anemia is defined as hemoglobin (HGB) < 120 g/L in adult males or < 110 g/L in adult females.Severity is categorized as: mild (HGB 90-120 g/L), moderate (60-90 g/L), severe (30-60 g/L), and very severe (<30 g/L).
Measured: After onset, up to 30 days
Incidence of pneumonia
Pneumonia is defined as the presence of clinical indications such as fever, cough, purulent sputum, or positive chest radiographic findings consistent with pulmonary infection.
Measured: From enrollment to the end of follow-up at 3 months
Incidence of deep vein thrombosis (DVT)
DVT is defined as thrombosis diagnosed by ultrasound or venography, with or without clinical symptoms such as limb pain or swelling.
Measured: After onset, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Nov 2023
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Xiaolin Chen, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College
- Responsible party
- Sponsor-investigator, Xiaolin Chen, MD, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07270419
- Sponsor's protocol ID
- KY2025-175-01
- Other IDs
- 2024ZD0539700
- Acronym
- aSAH-Omics
- Status last verified
- Nov 2025
- First submitted
- 26 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysmal Subarachnoid Hemorrhage Multi-Omics Research Program (aSAH-Omics) ：A Multicenter Clinical and Mechanistic Study
- ClinicalTrials.gov ID
- NCT07270419
- Acronym / sponsor ID
- aSAH-Omics / KY2025-175-01
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- Multi-Omics, Prognosis, Complications, Aneurysmal Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xiaolin Chen, MDUniversity, hospital or other
- Collaborators
- Peking Union Medical College
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening cerebrovascular emergency with high mortality and disability rates. Despite advances in neuroimaging and interventional techniques, outcomes remain poor for many patients due to complex post-rupture complications such as delayed cerebral ischemia (DCI), pneumonia, and other systemic injuries. These secondary events critically affect neurological recovery, yet their molecular mechanisms are not fully understood.
This multicenter study aims to investigate the biological basis of post-rupture complications and prognosis in patients with aSAH through integrated multi-omics and clinical data analysis. Biospecimens including blood, cerebrospinal fluid, urine, and other relevant tissues will be collected for genomic, transcriptomic, proteomic, metabolomic, and imaging-omic profiling. By linking molecular data with clinical and imaging indicators, the study seeks to identify key pathways and biomarkers associated with secondary injury and outcome heterogeneity.
Detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is a severe cerebrovascular emergency caused by the rupture of an intracranial aneurysm. Despite advances in neuroimaging and microsurgical or endovascular techniques, aSAH remains associated with high mortality and long-term disability. Post-rupture complications-such as delayed cerebral ischemia (DCI), pneumonia, and other systemic complications-are major determinants of neurological recovery and prognosis.
Following aneurysm rupture, a cascade of complex secondary injuries is triggered, critically influencing clinical outcomes. Beyond the initial hemorrhagic insult, secondary pathophysiological processes-including neuroinflammation, endothelial dysfunction, and blood-brain barrier disruption-play pivotal roles in mediating delayed brain injury and neurological deterioration. However, how these biological processes interact and contribute to heterogeneous outcomes remains poorly understood.
This multicenter study aims to elucidate the molecular mechanisms underlying post-rupture complications and prognosis in aSAH through integrative multi-omics and clinical data analysis. By combining genomic, transcriptomic, proteomic, metabolomic, and imaging-omic approaches using biospecimens such as blood, cerebrospinal fluid, urine, and other relevant tissues, this project seeks to identify key molecular pathways and biomarkers associated with secondary injury and outcome variation. The findings are expected to provide systematic insights into the biological basis of aSAH progression and establish a foundation for precision prediction and individualized management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with aneurysmal subarachnoid hemorrhage (aSAH) confirmed by CTA, or DSA, whose aneurysms are treated by microsurgical clipping or endovascular coiling within 72 hours after onset. Participants will be consecutively recruited from multiple tertiary neurosurgical centers.
Key inclusion criteria (6 listed)
- Adult patients aged ≥18 years;
- Confirmed diagnosis of aneurysmal subarachnoid hemorrhage (aSAH) by CTA, or DSA;
- Aneurysm secured by either microsurgical clipping or endovascular coiling during hospitalization;
- Time from onset to aneurysm treatment ≤ 72 hours;
- Availability of biospecimens, including blood, cerebrospinal fluid (CSF), urine, or fecal samples collected during hospitalization;
Key exclusion criteria (6 listed)
- History of previous intracranial aneurysm surgery or embolization;
- Non-aneurysmal SAH, traumatic SAH, or perimesencephalic non-aneurysmal hemorrhage;
- Presence of malignancy, severe hepatic or renal dysfunction, or other systemic diseases that may affect survival or biomarker expression;
- Severe cardiorespiratory insufficiency or unstable medical condition precluding study participation;
- Pregnancy or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Modified Rankin Scale (mRS) score for functional outcome
Time frame: 3, 6, and 12 months after onset
Functional outcome will be evaluated using the modified Rankin Scale (mRS), ranging from 0 (no symptoms) to 6 (death). Higher scores indicate greater disability. The distribution of mRS scores will be analyzed at predefined follow-up time points.
5 secondary outcomes
Incidence of rebleeding
Time frame: After onset, up to 30 days
Incidence of delayed cerebral ischemia (DCI)
Time frame: After onset, up to 30 days
Incidence of anemia
Time frame: After onset, up to 30 days
Incidence of pneumonia
Time frame: From enrollment to the end of follow-up at 3 months
Incidence of deep vein thrombosis (DVT)
Time frame: After onset, up to 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Xiaolin Chen, MD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Runting Li, MD (+86 15753166690, tt18080lrt@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin Scale (mRS) score for functional outcome (time frame: 3, 6, and 12 months after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.