Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT)

NCT07481656 · tracked via the Priya Life Science China tracker

Sponsor

Anhui Provincial Hospital

Phase

Phase 4

Started

2026-04-10

Last updated

2026-03-19

Condition(s) studied

Acute Brain InjuriesModerate to Severe Traumatic Brain Injury

Investigational drug(s) / intervention(s)

Recombinant Human Growth Hormone (rhGH) InjectionStandard Care (Treatment as Usual)

Recombinant Human Growth Hormone (rhGH) Injection: Recombinant human growth hormone is administered subcutaneously according to the study protocol. The recommended dose is 2-4 IU per day. For participants with blood glucose ≥11.1 mmol/L or aged 80 years and older, the recommended dose is 2-3 IU per day.

Standard Care (Treatment as Usual): Participants receive standard clinical care and/or routine observation without recombinant human growth hormone.

Study summary

This study is a multicenter, randomized controlled trial aimed at evaluating the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients who have suffered moderate to severe acute brain injuries complicated by hypoproteinemia.

Eligible participants, aged 60 and older, with acute brain injuries and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.

Clinical data will be collected at baseline and weekly for four weeks. The primary outcome measure will be the change in plasma albumin levels from baseline to Week 2. Secondary outcome measures will include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rates, hemoglobin levels, length of hospital stays, length of intensive care unit stays, and functional outcomes.

Safety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence that can help optimize nutritional support and rehabilitation strategies for elderly patients with acute brain injuries.This study is a multicenter, randomized controlled clinical trial designed to evaluate the effectiveness and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.

Eligible participants aged 60 years and older with acute brain injury and low serum albumin levels will be randomly assigned to either the growth hormone treatment group or the control group. The treatment group will receive recombinant human growth hormone in addition to standard medical care, while the control group will receive standard medical care alone.

Clinical data will be collected at baseline and weekly for four weeks. The primary outcome is the change in plasma albumin level from baseline to Week 2. Secondary outcomes include changes in total protein, prealbumin, insulin-like growth factor-1 levels, cumulative albumin infusion, infection rate, hemoglobin level, length of hospital stay, intensive care unit stay, and functional outcomes.

Safety outcomes and adverse events will be monitored throughout the study period. The results of this study are expected to provide evidence for optimizing nutritional support and rehabilitation strategies in elderly patients with acute brain injury.

Eligibility

Sex

ALL

Min age

60 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Age ≥ 60 years, male or female. 2. Hospitalized patients with acute brain injury (including traumatic brain injury, ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage) who had a Glasgow Coma Scale (GCS) score ≤ 12 at any time during hospitalization. 3. Presence of hypoalbuminemia, defined as serum albumin \< 35 g/L and/or prealbumin \< 200 mg/L after admission. 4. Willing and able to provide informed consent (by patient or legal representative). Exclusion Criteria: 1. Unstable vital signs, defined as deviations in body temperature, respiration, pulse, blood pressure, or oxygen saturation from normal ranges that, in the clinical judgment of the investigator, may jeopardize vital organ perfusion or indicate disease progression. 2. Active malignancy or history of malignancy with a disease-free interval of less than 5 years. 3. Diabetes mellitus with retinopathy. 4. Any other condition deemed unsuitable for participation by the investigator (e.g., severe renal/hepatic dysfunction, active infection, known hypersensitivity to growth hormone, or participation in another interventional trial).

Primary outcome measure(s)

Change in Plasma Albumin Level from Baseline to Week 2 — Baseline (within 7 days before first treatment) and Week 2 (±2 days) after treatment initiation.
The difference in plasma albumin level (g/L) between baseline (before treatment) and at Week 2 (±2 days) after initiation of treatment. This outcome will be compared between the growth hormone treatment group and the blank control group to assess the short-term effect of recombinant human growth hormone (rhGH) on hypoalbuminemia in elderly patients with moderate to severe acute brain injury.

Trial sites (1)

Facility	City	Region	Status
The First Affiliated Hospital of University of Science and Technology of China	Hefei	Anhui

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07481656 on ClinicalTrials.gov ↗ ← All trials in China