Study on Dynamic Changes of Serum IGF-1 Post-Cerebral Hemorrhage and Its Prognostic Correlation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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

Conditions

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Insulin-Like Growth Factor I

Keywords

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Intracerebral Hemorrhage Prognosis IGF-1

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Aged 18 to 75 years old;
2. Patients with intracerebral hemorrhage (NIHSS ≥5 points);
3. No history of cerebrovascular diseases with residual functional impairment before brain injury;
4. Hospitalized within 72 hours after injury;
5. BMI ≤28.

Exclusion Criteria

1. Patients with severe cardiac, hepatic, renal, or pulmonary dysfunction;
2. Glycated hemoglobin \>9.0% at screening;
3. History of hypothalamic-pituitary related diseases or severe endocrine diseases;
4. Use of drugs affecting endocrine function (such as glucocorticoids, growth hormones) within the past six months;
5. Pregnant patients. -

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Yin Yanmei

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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YanMei Yin, Master

Role: CONTACT

Phone: 18940259354

Email: [email protected]

Other Identifiers

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2025PS1176K(X1)

Identifier Type: -

Identifier Source: org_study_id