Multimodal Computed Tomography in Patients With Acute Hemorrhagic Stroke

NCT06061185 | Recruiting DMC

• 1 other identifier: KY 2024-007-02
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Acute hemorrhagic stroke is a series of neurosurgical diseases characterized by bleeding with high morbidity and mortality. It accounts for about 20% of all strokes worldwide and mainly includes subtypes such as intracerebral hemorrhage (ICH) and subarachnoid hemorrhage (SAH). Multimodal computed tomography including non-contrast computed tomography, computed tomography angiography and computed tomography perfusion, is of great important in understanding pathophysiological changes, evaluating prognosis and guiding interventions in these diseases.

Conditions

Acute Hemorrhagic Stroke

Keywords

Acute Hemorrhagic Stroke; Multimodal CT; Prognosis

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale (mRS)

  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

  At 3/6/12 months after onset

Secondary Outcomes (15)

• Mortality rate

  At 12 months after onset

• Total time spent on the intensive care unit (ICU)/stroke unit

  After treatment (max 60 days)

• Non-neurological systemic complications

  After onset (max 60 days)

• Delayed infarction

  After onset (max 30 days)

• Delayed ischemia

  After onset (max 30 days)

Study Arms (1)

Testing populations

All patients with the possibility of acute hemorrhagic stroke and suitable for multimodal CT examination

Device: Multimodal CT

Interventions

Multimodal CT DEVICE

Non-contrast computed tomography, computed tomography angiography and computed tomography perfusion

Testing populations

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presented to the emergency department with hemorrhagic stroke.

You may qualify if:

• age ≥ 18, ≤ 85 years;
• presence with hemorrhagic stroke

You may not qualify if:

• with a history of previous history of ischemic/hemorrhagic stroke;
• admission to the emergency department more than a week after symptom onset;
• serious medical history or existing comorbidities;
• physical disability due to previous diseases;
• prior treatment such as external ventricular drainage, digital subtraction angiography and lumbar puncture in other institution;
• poor original image quality;
• incomplete follow-up.

Sponsors & Collaborators

• Xiaolin Chen, MD: lead
• Peking University International Hospital: collaborator
• Zhangzhou Municipal Hospital of Fujian Province: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator
• Santai County People's Hospital: collaborator
• Jiujiang No.1 People's Hospital: collaborator
• Qin Zhou NO.1 People's Hospital: collaborator
• Sichuan Academy of Medical Sciences: collaborator
• Linyi People's Hospital: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

RECRUITING

Study Officials

• 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 CHAIR

Central Study Contacts

Xiaolin Chen, M.D.

CONTACT

13810624845; chenxiaolin@bjtth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2023
• First Posted: September 29, 2023
• Study Start: January 1, 2020
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): April 1, 2032
• Last Updated: April 4, 2025

Record last verified: 2025-04

Locations

CN (1)