Aneurysmal Subarachnoid Hemorrhage (aSAH)NCT07160088
DIND in Patients With aSAH : Real World Study
An observational study of Aneurysmal Subarachnoid Hemorrhage (aSAH), run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
In recent years, with the active application of clinical monitoring and treatment methods, the survival rate of patients with aneurysmal subarachnoid hemorrhage (SAH) has improved, but still a certain proportion of patients develop chronic and disabling neurological deficits, namely delayed ischemic neurological… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage (aSAH)
- What is being tested?
- Observational
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 3 Sep 2025to 31 Dec 2027
- 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 to 90 years
- All sexes
- Adult, Older adult
Study population: The study will enroll all the adult aSAH patients admitted in the Intensive Care Units (ICU) of several hospitals located in China, who meet the inclusion/exclusion criteria of this study.
Who may be able to join
- Age ≥ 18 years old
- Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm confirmed by cerebral angiotomography or intracranial vessel angiography, requiring admission to the Intensive Care Unit (ICU).
- Signature of the Informed Consent Form for participation in the study in accordance with local applicable regulations.
Who cannot join
- Age < 18 years old
- Primary diagnosis of subarachnoid hemorrhage withouth a visible aneurysm, i.e., post-traumatic or caused by an arteriovenous malformation or bleeding from a brain tumor.
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
Department of neurosurgery, Xuanwu hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
15101597091, jianglidanfine@163.com
About this study
Official title: Delayed Ischemic Neurological Deficit in Patients With Aneurysmal Subarachnoid Hemorrhage: Real World Study (DINDaSAH)
In recent years, with the active application of clinical monitoring and treatment methods, the survival rate of patients with aneurysmal subarachnoid hemorrhage (SAH) has improved, but still a certain proportion of patients develop chronic and disabling neurological deficits, namely delayed ischemic neurological deficits (DIND). The incidence of DIND is not clear, and the causes are diverse. Symptomatic vasospasm is only one of the possible causes, and early diagnosis is difficult. Up to now, there is no gold standard for diagnosis and no relevant treatment guidelines.
Given these reasons, this study intends to conduct a prospective multicenter observational study to collect relevant information on diagnostic methods (neurological symptoms in clinical examinations or changes in monitoring by instruments) and treatment methods, describe the incidence of delayed cerebral ischemia (DIND) in patients with subarachnoid hemorrhage (SAH), evaluate the different treatment strategies adopted by participating centers, and compare these strategies in terms of mortality and short-term and long-term neurological outcomes, and describe the indications, usefulness, and treatment intensity of intracranial pressure monitoring of the brain parenchyma during SAH in patients.
Read more
Study design: This study is a multicenter, prospective, observational study. The study subjects are patients with subarachnoid hemorrhage as the primary diagnosis, admitted to the intensive care unit and receiving treatment. The treatment of patients with subarachnoid hemorrhage (SAH) and delayed cerebral ischemia (DIND) is the responsibility of the professional medical and surgical teams of each center.
Study period: The enrollment period is 12 months from the start of ethical approval, and the follow-up period is 12 months after the onset.
Inclusion criteria:
① Age ≥ 18 years; ② Aneurysmal subarachnoid hemorrhage (confirmed by DSA/CTA); ③ Admitted to the intensive care unit; ④ Signed informed consent.
Exclusion criteria:
① Unidentified cause of subarachnoid hemorrhage (no visible aneurysm); ② Traumatic SAH; ③ Complicated with brain tumors or arteriovenous malformations.
Endpoints:
Primary endpoints: The occurrence of suspected DIND: Whether it is indicated by neurological clinical examination (such as the patient being conscious or in a light sedated state), or by the monitoring of instruments (if clinical examination is impossible), suggesting the possibility of DIND, regardless of whether there is imaging confirmation or not, can be considered as suspected DIND.
Secondly endpoints: - The clinical application of diagnostic and monitoring methods in the identification and management of DIND in patients with aSAH.
- Evaluation of mortality and neurological functional prognosis (GOSE and mRS) at 6 months and 12 months after onset.
- Comparison of changes in intracranial pressure (ICP) in patients with ICP monitoring and the intensity of the treatment received (Therapy Intensity Level, TIL).
Sample size:
The enrollment will be as much as possible during the enrollment period (totally approximately 1000 cases).
- Being tested
- Observational
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This is an observational study without study-related intervention. All the treatments will be depended on the attending doctors and according to the related guidelines.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DIND in patients with SAH, where-after excluding other possible causes such as hydrocephalus, seizures, rebleeding, and hyponatremia.
In a patient who is awake or can be awakened to undergo a clinical neurological examination, DIND is diagnosed when there is evidence of either: a focal neurological deterioration (at least one of the following: hemiparesis, aphasia, hemianopsia, or neglect), or a global deterioration (sudden neurological worsening resulting in a decrease of at least two points on the GCS or on the NIHSS, or the appearance of anisocoria or non-reactive pupils).
In comatose or non-awakable patients, DIND is diagnosed when at least one of the following alterations is observed:
NPi: <3 on a scale from 0 to 5 TCD:vasospasm of a major cerebral artery CEEG:presence of reduced alpha variability and/or a decreased α/δ ratio, or the appearance of depolarization waves in clusters of 2-5 mm/min PbtO2:<20 mmHg CTP:ischemic core or penumbra, or <15 ml/100g/min DSA:reduction of ≥50% in the diameter of a major cerebral artery CT/MRI:presence of ischemic lesion
Measured: From Day 1 to one month
Secondary outcomes (2)
Mortality and neurological-functional outcomes (GOSE - Glasgow Outcome Scale Extended) at 6 and 12 months after the acute event
In Glasgow Outcome Scale Extended (GOSE), the minimum is 1(dead) and maximum 8 (Good recovery, near complete), higher scores mean a better outcome.
Measured: from Day 1 to follow-up at 12 months
Mortality and neurological-functional outcomes (mRS - modified Rankin Scale) at 6 and 12 months after the acute event
In mRS (modified Rankin Scale), the minimum is 0 (complete recovered), and maximum 6 (dead), higher scores mean a worse outcome.
Measured: from Day 1 to follow-up at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start3 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 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 Hemorrhage (aSAH)Studies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lidan Jiang, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07160088
- Sponsor's protocol ID
- [2025]264-002
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delayed Ischemic Neurological Deficit in Patients With Aneurysmal Subarachnoid Hemorrhage: Real World Study (DINDaSAH)
- ClinicalTrials.gov ID
- NCT07160088
- Acronym / sponsor ID
- [2025]264-002
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 3 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Sep 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.
In recent years, with the active application of clinical monitoring and treatment methods, the survival rate of patients with aneurysmal subarachnoid hemorrhage (SAH) has improved, but still a certain proportion of patients develop chronic and disabling neurological deficits, namely delayed ischemic neurological deficits (DIND). The incidence of DIND is not clear, and the causes are diverse. Symptomatic vasospasm is only one of the possible causes, and early diagnosis is difficult. Up to now, there is no gold standard for diagnosis and no relevant treatment guidelines.
Given these reasons, this study intends to conduct a prospective multicenter observational study to collect relevant information on diagnostic methods (neurological symptoms in clinical examinations or changes in monitoring by instruments) and treatment methods, describe the incidence of delayed cerebral ischemia (DIND) in patients with subarachnoid hemorrhage (SAH), evaluate the different treatment strategies adopted by participating centers, and compare these strategies in terms of mortality and short-term and long-term neurological outcomes, and describe the indications, usefulness, and treatment intensity of intracranial pressure monitoring of the brain parenchyma during SAH in patients.
Study design: This study is a multicenter, prospective, observational study. The study subjects are patients with subarachnoid hemorrhage as the primary diagnosis, admitted to the intensive care unit and receiving treatment. The treatment of patients with subarachnoid hemorrhage (SAH) and delayed cerebral ischemia (DIND) is the responsibility of the professional medical and surgical teams of each center.
Study period: The enrollment period is 12 months from the start of ethical approval, and the follow-up period is 12 months after the onset.
Inclusion criteria:
① Age ≥ 18 years; ② Aneurysmal subarachnoid hemorrhage (confirmed by DSA/CTA); ③ Admitted to the intensive care unit; ④ Signed informed consent.
Exclusion criteria:
① Unidentified cause of subarachnoid hemorrhage (no visible aneurysm); ② Traumatic SAH; ③ Complicated with brain tumors or arteriovenous malformations.
Endpoints:
Primary endpoints: The occurrence of suspected DIND: Whether it is indicated by neurological clinical examination (such as the patient being conscious or in a light sedated state), or by the monitoring of instruments (if clinical examination is impossible), suggesting the possibility of DIND, regardless of whether there is imaging confirmation or not, can be considered as suspected DIND.
Secondly endpoints: - The clinical application of diagnostic and monitoring methods in the identification and management of DIND in patients with aSAH.
- Evaluation of mortality and neurological functional prognosis (GOSE and mRS) at 6 months and 12 months after onset.
- Comparison of changes in intracranial pressure (ICP) in patients with ICP monitoring and the intensity of the treatment received (Therapy Intensity Level, TIL).
Sample size:
The enrollment will be as much as possible during the enrollment period (totally approximately 1000 cases).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study will enroll all the adult aSAH patients admitted in the Intensive Care Units (ICU) of several hospitals located in China, who meet the inclusion/exclusion criteria of this study.
Key inclusion criteria (3 listed)
- Age ≥ 18 years old
- Primary diagnosis of subarachnoid hemorrhage due to rupture of a cerebral artery aneurysm confirmed by cerebral angiotomography or intracranial vessel angiography, requiring admission to the Intensive Care Unit (ICU).
- Signature of the Informed Consent Form for participation in the study in accordance with local applicable regulations.
Key exclusion criteria (2 listed)
- Age < 18 years old
- Primary diagnosis of subarachnoid hemorrhage withouth a visible aneurysm, i.e., post-traumatic or caused by an arteriovenous malformation or bleeding from a brain tumor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis is an observational study without study-related intervention. All the treatments will be depended on the attending doctors and according to the related guidelines. | Other | – |
Primary outcome
Incidence of DIND in patients with SAH, where-after excluding other possible causes such as hydrocephalus, seizures, rebleeding, and hyponatremia.
Time frame: From Day 1 to one month
In a patient who is awake or can be awakened to undergo a clinical neurological examination, DIND is diagnosed when there is evidence of either: a focal neurological deterioration (at least one of the following: hemiparesis, aphasia, hemianopsia, or neglect), or a global deterioration (sudden neurological worsening resulting in a decrease of at least two points on the GCS or on the NIHSS, or the appearance of anisocoria or non-reactive pupils). In comatose or non-awakable patients, DIND is diagnosed when at least one of the following alterations is observed: NPi: <3 on a scale from 0 to 5 TCD:vasospasm of a major cerebral artery CEEG:presence of reduced alpha variability and/or a decreased α/δ ratio, or the appearance of depolarization waves in clusters of 2-5 mm/min PbtO2:<20 mmHg CTP:ischemic core or penumbra, or <15 ml/100g/min DSA:reduction of ≥50% in the diameter of a major cerebral artery CT/MRI:presence of ischemic lesion
2 secondary outcomes
Mortality and neurological-functional outcomes (GOSE - Glasgow Outcome Scale Extended) at 6 and 12 months after the acute event
Time frame: from Day 1 to follow-up at 12 months
Mortality and neurological-functional outcomes (mRS - modified Rankin Scale) at 6 and 12 months after the acute event
Time frame: from Day 1 to follow-up at 12 months
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 2 Jan 2026.
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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 (aSAH), run by Xuanwu Hospital, Beijing 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 3 inclusion and 2 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 2 Jan 2026. 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 Lidan Jiang (86-15101597091, jianglidanfine@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DIND in patients with SAH, where-after excluding other possible causes such as hydrocephalus, seizures, rebleeding, and hyponatremia. (time frame: From Day 1 to one month). 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 2 Jan 2026.