DIND in Patients With aSAH : Real World Study

NCT07160088 | Recruiting DMC

• 1 other identifier: [2025]264-002
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Aneurysmal Subarachnoid Hemorrhage (aSAH)

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  from Day 1 to follow-up at 12 months

Interventions

Observational OTHER

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xuanwu Hospital, Beijing: lead

Study Sites (1)

Department of neurosurgery, Xuanwu hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Central Study Contacts

Lidan Jiang

CONTACT

86-15101597091; jianglidanfine@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 8, 2025
• Study Start: September 3, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 2, 2026

Record last verified: 2025-08

Locations

CN (1)