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

Official title

A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia

Overview

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.

Detailed description

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.

Interventions

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

Primary outcome measures

• Change in Plasma Albumin Level from Baseline to Week 2 [Time frame: Baseline (within 7 days before first treatment) and Week 2 (±2 days) after treatment initiation.]

Secondary outcome measures (12)

• Change in Total Protein (TP) from Baseline to Weeks 1, 2, 3, and 4 [Time frame: Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• Change in Albumin (ALB) from Baseline to Weeks 1, 2, 3, and 4 [Time frame: Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• Change in Prealbumin (PA) from Baseline to Weeks 1, 2, 3, and 4 [Time frame: Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• Cumulative Amount of Albumin Infused [Time frame: Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• 24-hour Urine Urea Nitrogen (24h UUN) [Time frame: Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.]
• Change in Z-score of Plasma Insulin-like Growth Factor 1 (IGF-1) Level from Baseline [Time frame: Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• Hemoglobin Level at Weeks 1, 2, 3, and 4 [Time frame: At weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• Cumulative Blood Transfusion [Time frame: Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.]
• Cumulative Incidence and Infections [Time frame: Up to Weeks 2 and 4 (±2 days) after treatment initiation]
• Time to First Infection [Time frame: From treatment initiation to Week 4 (±2 days)]
• C-reactive Protein (CRP) Level at Weeks 1, 2, 3, and 4 [Time frame: At weeks 1, 2, 3, 4 (±2 days) after treatment initiation]
• Total Lymphocyte Count at Weeks 1, 2, 3, and 4 [Time frame: At Weeks 1, 2, 3, and 4 (±2 days) after treatment initiation.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The First Affiliated Hospital of University of Science and Technology of China — Hefei

Identifiers

NCT: NCT07481656 · 2025-KY630

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗