MCTASH: Multimodal Computed Tomography of Aneurysmal Subarachnoid Hemorrhage
Study Details
Study Description
Brief Summary
Aneurysmal subarachnoid hemorrhage (aSAH) is a neurosurgical disease with high morbidity and mortality. It accounts for approximately 5% of all strokes worldwide and has an incidence rate of 6 to 16 per 100,000 person-years. Multimodal computed tomography including non-contrast computed tomography, computed tomography angiography and computed tomography perfusion, is of great important in observing aneurysm morphology, understanding pathophysiological changes and evaluating the prognosis of the disease
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Study overview: The data of the population in the MACTASH study will be prospectively collected. The CT strategies for aSAH are mainly three categories: non-contrast computed tomography, computed tomography angiography and computed tomography perfusion. Each participants will be followed at least until 1 year after discharge. Finally, investigators will clarify the prognostic value of multimodal CT for patients with aSAH.
Sample size: About 5000 patients will be enrolled in this study. All the population will be expected to undergo non-contrast computed tomography, computed tomography angiography and computed tomography perfusion.
Study endpoints: The neurological function prognosis, delayed cerebral ischemia, vasospasm, cognition dysfunction and systemic in-hospital systemic complications will be evaluated and follow-up would be completed.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Testing populations All patients with the possibility of aneurysmal subarachnoid hemorrhage and suitable for multimodal CT examination |
Device: Multimodal CT
Non-contrast computed tomography, computed tomography angiography and computed tomography perfusion
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Outcome Measures
Primary Outcome Measures
- modified Ranking Scale score at discharge [At discharge (up to day 15)]
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
- modified Ranking Scale score at 30 days after discharge [At 30 days after discharge]
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
- modified Ranking Scale score at 90 days after discharge [At 90 days after discharge]
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
- modified Ranking Scale score at 180 days after discharge [At 180 days after discharge]
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
- modified Ranking Scale score at 1 year after discharge [At 1 year after discharge]
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. No significant disability. Able to carry out all usual activities, despite some symptoms. Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. Moderate disability. Requires some help, but able to walk unassisted. Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. Severe disability. Requires constant nursing care and attention, bedridden, incontinent. Dead
- Delayed cerebral ischemia [3-14 days after rupture]
1) new cerebral infarction identified on CT or MRI, after exclusion of procedure-related infarctions; 2) clinical deterioration, after exclusion of other potential causes of clinical deterioration.
- Vasospasm [3-14 days after rupture]
evidence of cerebral arterial narrowing, regardless of clinical symptoms, based on digital subtraction angiography findings and impression of the neurointerventional performing the procedure as well as daily transcranial Doppler performed by registered vascular technologists and interpreted by board-certified neurooncologists .
Secondary Outcome Measures
- Major adverse cardiac events [During hospitalization (up to day 15)]
The occurrence of an arrhythmia, myocardial injury, acute heart failure, repeat revascularization, and cardiac arrest, or as defined in our electronic medical records. Number of patients experienced with major adverse cardiac events will be recorded.
- Stress related gastrointestinal bleeding [During hospitalization(up to day 15)]
No previous history of gastrointestinal ulcer or hemorrhage, presented with any overt bleeding with or without clinically significant complications, including hematemesis, or red blood or "hemoccult positive coffee grounded" materials in a nasogastric aspirate, melena. Number of patients experienced with stress related gastrointestinal bleeding will be recorded.
- Liver dysfunction [During hospitalization (up to day 15)]
Bilirubin concentration >2 mg/dL and coagulation disorders with international normalized ratio > 1.5. Number of patients experienced with liver dysfunction will be recorded.
- Anemia [During hospitalization (up to day 15)]
Hemoglobin < 120 g/L for adult males and 110 g/L for adult females. Mild anemia: hemoglobin 90-120 g/L, moderate anemia: hemoglobin 60-90 g/L, severe anemia: hemoglobin 30-60 g/L, and very severe anemia: hemoglobin less than 30 g/L. Number of patients experienced with anemia will be recorded.
- Hypoproteinemia [During hospitalization (up to day 15)]
Serum total protein level less than 60g/L or albumin level less than 35g/L. Number of patients experienced with hypoproteinemia will be recorded.
- Postoperative pneumonia [During hospitalization (up to day 15)]
Fever, increased white blood cell and C-reactive protein levels, and chest radiograph showed pulmonary infiltrates within 30 days after surgery, which required antibiotic therapy by a surgeon, according to the modified Centers for Disease Control and Prevention criteria. Number of patients experienced with postoperative pneumonia will be recorded.
- Deep vein thrombosis [During hospitalization (up to day 15)]
Cross-sectional vein incompressibility, direct thrombus imaging with vein enlargement, and abnormal spectral and color-Doppler flow under venous ultrasound. Number of patients experienced with deep vein thrombosis will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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age ≥ 18 years;
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without a history of previous SAH;
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complete follow-up.
Exclusion Criteria:
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physical disability due to previous diseases;
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prior treatment including external ventricular drainage, lumbar puncture, angiography, intubation, and/or mechanical ventilation before admission to our hospital;
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missing medical information.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Tiantan Hospital | Beijing | Beijing | China | 100070 |
Sponsors and Collaborators
- Xiaolin Chen, MD
Investigators
- Study Chair: Tu Li, M.D., Beijing Tiantan Hospital
- Study Chair: Zhenshan Song, M.D., Beijing Tiantan Hospital
- Study Chair: Runting Li, M.D., Beijing Tiantan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY 2021-008-01