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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06462274
Other study ID # Neurosurg03
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date December 1, 2026

Study information

Verified date June 2024
Source Southwest Hospital, China
Contact Rong Hu, Ph.D
Phone 86-23-68765761
Email huchrong@aliyun.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Intracerebral hemorrhage (ICH) is a subtype of stroke associated with high mortality and disability. Basic and clinical research has contributed to our understanding of the complex pathophysiology in ICH. However, questions regarding acute diagnosis, therapeutic decisions, and prognostication of ICH remain unanswered. Molecular biomarkers and imaging markers have revolutionalized diagnosis and treatment of many diseases, such as troponin use in myocardial infarction and magnetic resonance imaging (MRI) scan in ischemic stroke. Therefore, the investigators aim to discovery the potential biomarkers by screening samples of blood, cerebral spinal fluid, urine, saliva, and even tissues (if available) from ICH patients, and imaging markers via serial multimodality imaging scans such as computed tomography(CT), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), positron emission tomography (PET), etc. These molecular and imaging markers would assist in contributing additional information to current tools for onset warning, diagnosis, therapy monitoring, risk stratification, intervention and prognosis for ICH patients.


Description:

Intracerebral hemorrhage (ICH) is one of the most serious subtypes of stroke, affecting approximately 2-3 million people worldwide each year. About one third of people with ICH die early after onset and the majority of survivors are left with major long-term disability. Today little is known about the characteristic changes in molecules from body samples and pictures from multimodality imaging scans. In this study, the investigators aim to reveal the potential biomarkers by screening samples of blood, cerebral spinal fluid, urine, saliva, and even tissues (if available) from ICH patients, and imaging markers via serial multimodality imaging scans such as computed tomography(CT), magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), positron emission tomography (PET), etc, which will bring insights into pathophysiological mechanisms and addition of new tools for onset warning, diagnosis, therapy monitoring, risk stratification, intervention and prognosis for ICH patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 1, 2026
Est. primary completion date June 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Individuals aged 18-80 years 2. Hematoma size is more than 5 ml 3. Evidence of a spontaneous ICH on CT scan 4. Patient within 72 hours of ictus 5. Glasgow Coma Scale (GCS) Score of 5-15. 6. The history of hypertension Exclusion Criteria: 1. Individuals with age < 18 years or > 80 years 2. Clear evidence that the hemorrhage is due to an aneurysm, arteriovenous malformation or other cerebrovascular diseases. 3. ICH secondary to tumor or trauma.. 4. If the haematological effects of any previous anticoagulants are not completely reversed. 5. Patients with heart insufficiency, lungs insufficiency, renal insufficiency, hepatic insufficiency, autoimmune diseases and other organ diseases with severe dysfunction.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
body sample collection and imaging scan


Locations

Country Name City State
China Department of Neurosurgery , Southwest Hospital, Third Military Medical University, Chongqing Chongqing

Sponsors (1)

Lead Sponsor Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Biomarkers Diseased tissue from the patient is collected at the time of hematoma removal. These tissues are then immediately prepared and detected by proteome mass spectrometry. The results will be further analyzed by bioinformatics analysis to reveal the expression of proteins in the diseased tissues of patients with intracerebral hemorrhage as potential biomarkers. Immediately after collecting tissues
Primary CT imaging features Patients will undergo CT imaging examinations to evaluate the patient's hematoma volume, hematoma location, hematoma morphology, hematoma density and other imaging characteristics Within 1 month of onset
Primary CTA imaging markers The patient will undergo CTA imaging to evaluate the cerebrovascular features of the patient Within 1 month of onset
Primary MR imaging markers Magnetic resonance imaging was performed to evaluate the patient's hematoma morphology, signal, and edema around the hematoma cavity Within 1 month of onset
Secondary Glasgow Outcome Scale Extended (GOSE) GOS-E subdivides the categories of severe and moderate disability and good recovery using a scale of 1 to 8 where 1 = death, 2 = vegetative state, 3 = lower severe disability, 4 = upper severe disability, 5 = lower moderate disability, 6 = upper moderate disability, 7 = lower good recovery, and 8 = upper good recovery. Structured telephone interviews have been developed and validated for the GOS-E and these questions were incorporated into the follow-up survey. GOS-E was dichotomized into unfavorable (1 to 4) and favorable (5 to 8) outcomes. 1 year
Secondary modified Rankin scale (mRS) Functional outcome (comparing the intervention group to the control), assessed with the modified Rankin Scale (mRS) at 6 months.The mRS is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. 1 year
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