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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Brain Injuries; Moderate to Severe Traumatic Brain Injury
• Intervention / Treatment: Drug: Recombinant Human Growth Hormone (rhGH) Injection; Other: Standard Care (Treatment as Usual)

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hao Xu, PhD; Phone Number: 18019576586; Email: Xuhao2021@ustc.edu.cn
• Study Contact Backup: Name: ChunSheng Xia, MD; Email: xiassen@163.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230036
      • The First Affiliated Hospital of University of Science and Technology of China
      • Contact: Hao Xu, PhD; Phone Number: 18019576586; Email: Xuhao2021@ustc.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rhGH Treatment Group; Participants receive recombinant human growth hormone 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.	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.
Active Comparator: Standard Care Group; Participants receive standard clinical care or routine observation without recombinant human growth hormone, according to usual practice and individual clinical conditions.	Other: Standard Care (Treatment as Usual); Participants receive standard clinical care and/or routine observation without recombinant human growth hormone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma Albumin Level from Baseline to Week 2	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.	Baseline (within 7 days before first treatment) and Week 2 (±2 days) after treatment initiation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Total Protein (TP) from Baseline to Weeks 1, 2, 3, and 4	The difference in serum total protein level (g/L) from baseline to Weeks 1, 2, 3, and 4 after treatment initiation.	Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Change in Albumin (ALB) from Baseline to Weeks 1, 2, 3, and 4	The difference in serum albumin level (g/L) from baseline to Weeks 1, 2, 3, and 4 after treatment initiation.	Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Change in Prealbumin (PA) from Baseline to Weeks 1, 2, 3, and 4	The difference in serum prealbumin level (mg/L) from baseline to Weeks 1, 2, 3, and 4 after treatment initiation.	Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Cumulative Amount of Albumin Infused	The total amount of exogenous albumin (in grams) administered to the patient from baseline through Weeks 1, 2, 3, and 4 after treatment initiation.	Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
24-hour Urine Urea Nitrogen (24h UUN)	The value of 24-hour urine urea nitrogen (mmol/24h or g/24h) measured at Weeks 1, 2, 3, and 4 after treatment initiation.	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	The change in the Z-score of plasma IGF-1 level from baseline to Weeks 1, 2, 3, and 4after treatment initiation.	Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Hemoglobin Level at Weeks 1, 2, 3, and 4	Hemoglobin concentration (g/L) measured at Weeks 1, 2, 3, and 4 after treatment initiation.	At weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Cumulative Blood Transfusion	The cumulative volume (mL) or number of units of packed red blood cells transfused from baseline through Weeks 1, 2, 3, and 4 after treatment initiation.	Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.
Cumulative Incidence and Infections	The occurrence (yes/no) and cumulative frequency of any infection (e.g., pulmonary, urinary, central nervous system) occurring within Weeks 2 and 4 after treatment initiation.	Up to Weeks 2 and 4 (±2 days) after treatment initiation
Time to First Infection	The time (in days) from treatment initiation to the onset of the first infection, assessed within the 4-week follow-up period.	From treatment initiation to Week 4 (±2 days)
C-reactive Protein (CRP) Level at Weeks 1, 2, 3, and 4	Level of C-reactive protein (CRP, mg/L) as a marker of inflammation, measured at Weeks 1, 2, 3, and 4 after treatment initiation.	At weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Total Lymphocyte Count at Weeks 1, 2, 3, and 4	Total lymphocyte count (×10⁹/L) as a marker of immune status, measured at Weeks 1, 2, 3, and 4 after treatment initiation.	At Weeks 1, 2, 3, and 4 (±2 days) after treatment initiation.
Length of Hospital Stay	The total number of days from hospital admission to discharge for any reason.	From the date of hospital admission to the date of discharge for any reason, assessed up to 6 months.
Length of Intensive Care Unit (ICU) Stay	The total number of days spent in the Intensive Care Unit (ICU) during the hospitalization.	From the date of ICU admission to the date of ICU discharge, assessed up to 6 months
Glasgow Outcome Scale Extended (GOSE) Score at Week 4	Functional neurological outcome assessed using the Glasgow Outcome Scale Extended (GOSE) at Week 4 after treatment initiation. Scores range from 1 (death) to 8 (upper good recovery).	At Week 4 (±2 days) after treatment initiation.
Duration of Mechanical Ventilation (Subgroup Analysis)	The total duration (in hours or days) of mechanical ventilation during hospitalization, analyzed in the subgroup of patients who required mechanical ventilation. Duration is measured from initiation of ventilation until first successful extubation or death from any cause, whichever occurs first.	From the initiation of mechanical ventilation until the date of first successful extubation or death from any cause, whichever came first, assessed up to 6 months
Change in Hemoglobin in Anemic Subgroup (Hemoglobin < 95 g/L)	The change in hemoglobin level (g/L) from baseline to Weeks 1, 2, 3, and 4 in the subgroup of patients with anemia (hemoglobin < 95 g/L) at baseline.	Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital
• Collaborators: Fuyang people's hospital; The First Affiliated Hospital of Bengbu Medical University; the First Affiliated Hospital of Anhui University of Science and Technology
• Investigators: Study Chair: Hao Xu, The First Affiliated Hospital of University of Science and Technology of China

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2028

Study Registration Dates

• First Submitted: February 8, 2026
• First Submitted That Met QC Criteria: March 16, 2026
• First Posted (Actual): March 19, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rhGH; recombinant human growth hormone; hypoproteinemia; Moderate to Severe Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Hematologic Diseases; Craniocerebral Trauma; Trauma, Nervous System; Blood Protein Disorders; Hemic and Lymphatic Diseases; Brain Injuries; Hypoproteinemia; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Health Services Administration; Health Care Quality, Access, and Evaluation; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Quality of Health Care; Quality Indicators, Health Care; Pituitary Hormones; Pituitary Hormones, Anterior; Standard of Care; Therapeutics; Growth Hormone
• Other Study ID Numbers: 2025-KY630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data (IPF) with researchers outside the study team. The primary reasons include protecting participant confidentiality and the absence of a formal data-sharing agreement between the participating multicenter sites at this stage of the research.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No