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

This study is a multicenter, prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of recombinant human growth hormone (rhGH) in elderly patients with moderate to severe acute brain injury complicated by hypoproteinemia.

Eligible patients aged 60 years and older who are diagnosed with moderate to severe acute brain injury and have serum albumin levels below 35 g/L will be enrolled. After obtaining informed consent, participants will be randomly assigned in a 1:1 ratio to either the rhGH treatment group or the control group using a centralized randomization system.

Patients in the treatment group will receive subcutaneous recombinant human growth hormone in addition to standard medical treatment and nutritional support. Patients in the control group will receive standard medical treatment and nutritional support alone. The dosage and duration of rhGH administration will follow the study protocol.

Baseline demographic data, medical history, and clinical characteristics will be collected at enrollment. Laboratory parameters including serum albumin, total protein, prealbumin, insulin-like growth factor-1, hemoglobin, and inflammatory markers will be measured at baseline and weekly for four weeks.

The primary outcome measure is the change in plasma albumin level from baseline to Week 2. Secondary outcome measures include changes in nutritional indicators, cumulative albumin infusion volume, incidence of infection, length of intensive care unit stay, total hospital stay, functional recovery, and mortality during hospitalization.

Safety assessments will include routine laboratory tests, monitoring of vital signs, and recording of adverse events and serious adverse events throughout the study period. An independent data monitoring committee will oversee study safety and data quality.

All data will be collected using standardized case report forms and entered into a secure electronic database. Data management and statistical analyses will be conducted in accordance with the prespecified statistical analysis plan.

The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Ethical approval has been obtained from the institutional review boards of all participating centers, and written informed consent will be obtained from all participants or their legally authorized representatives.

Inclusion criteria

• Age ≥ 60 years, male or female.
• 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.
• Presence of hypoalbuminemia, defined as serum albumin < 35 g/L and/or prealbumin < 200 mg/L after admission.
• Willing and able to provide informed consent (by patient or legal representative).

Exclusion criteria

• 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.
• Active malignancy or history of malignancy with a disease-free interval of less than 5 years.
• Diabetes mellitus with retinopathy.
• 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).