Study on Dynamic Changes of Serum IGF-1 Post-Cerebral Hemorrhage and Its Prognostic Correlation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Insulin-Like Growth Factor I. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on the Dynamic Changes of Serum IGF-1 After Cerebral Hemorrhage and Its Correlation With Prognosis of Patients
Overview
The purpose of this study is to dynamically observe the dynamic changes of serum IGF-1 after intracerebral hemorrhage, explore the impact and correlation of serum IGF-1 with the severity of the patient's condition and prognosis, and provide a reference for clinical treatment timing.
Detailed description
Research Objectives
1. Monitor the dynamic changes in serum IGF-1 concentration in patients with intracerebral hemorrhage at different time points (within 3 days, 14 days, 1 month, 2 months, and 4 months after onset). 2. Analyze the correlation between serum IGF-1 levels and the severity of intracerebral hemorrhage, imaging findings, and prognosis. 3. Explore the clinical value of serum IGF-1 as a biomarker for intracerebral hemorrhage repair. 4. Provide a reference for the clinical treatment timing of IGF-1-related drugs and therapies (such as rh growth hormone, rhIGF-1, etc.).
Experimental Methods
Screening Period:
Within 3 days after onset, record the demographic data, etiology, medical history, complications, disease course, and main clinical manifestations of the subjects during the screening period. Blood sampling for laboratory tests (between 06:00-08:00 in the morning within 3 days after onset) includes: complete blood count, IGF-1, GH, IGFBP-3, LDL-C, thyroid function T4, serum cortisol, ACTH, testosterone or progesterone, serum CRP, fasting blood glucose, glycated hemoglobin. Perform head CT and NIHSS scoring.
Follow-up Period:
At the 15th day, 1st month, and 2nd month of the subject's disease course:
Conduct laboratory tests for IGF-1, GH, and IGFBP-3. Evaluate using the Modified Barthel Index (MBI), Modified Rankin Scale (MRS), Glasgow Coma Scale (GCS), Mini-Mental State Examination (MMSE), PHQ-9 Depression Screening Scale (PHQ-9), and World Health Organization Quality of Life-BREF (WHOQOL-BREF).
At the 4th month of the subject's disease course:
Perform laboratory tests for complete blood count, IGF-1, GH, IGFBP-3, LDL-C, thyroid function T4, serum cortisol, ACTH, testosterone or progesterone, CRP, fasting blood glucose, and glycated hemoglobin.
Evaluate using the same scales as above (MBI, MRS, GCS, MMSE, PHQ-9, WHOQOL-BREF).
Grouping Based on Dynamic Changes in Serum IGF-1:
Convert IGF-1 values to IGF-1 SD (standard deviation) by referencing the age-specific reference values for IGF-1 in healthy Chinese populations (Peking Union Medical College).
IGF-1 Decreased Group: IGF-1 \< 0SD IGF-1 Normal Group: 0SD ≤ IGF-1 ≤ 2SD
Dynamic change-based grouping:
① Persistent IGF-1 Decrease Group: IGF-1 remains \< 0SD throughout dynamic observation.
② IGF-1 Decrease to Normal Group: IGF-1 first \< 0SD, then recovers to \> 0SD.
③ Persistent IGF-1 Normal Group: IGF-1 remains \> 0SD throughout dynamic observation.
Statistical Analysis Based on Experimental Data
Primary outcome measures
- The relationship between serum IGF-1 levels within 3 days after intracerebral hemorrhage and the severity of the condition (referring to NIHSS score) [Time frame: 3 days after intracerebral]
Secondary outcome measures (1)
- The correlation between the dynamic change trend of IGF-1 after intracerebral hemorrhage and the prognosis of patients [Time frame: The 5th month]
Eligibility criteria
Inclusion criteria
- Aged 18 to 75 years old;
- Patients with intracerebral hemorrhage (NIHSS ≥5 points);
- No history of cerebrovascular diseases with residual functional impairment before brain injury;
- Hospitalized within 72 hours after injury;
- BMI ≤28.
Exclusion criteria
- Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction;
- Glycated hemoglobin >9.0% at screening;
- History of hypothalamic-pituitary related diseases or severe endocrine diseases;
- Use of drugs affecting endocrine function (such as glucocorticoids, growth hormones) within the past six months;
- Pregnant patients. -
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07043504 · 2025PS1176K(X1)