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

NCT07481656 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 2025-KY630
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Brain Injuries; Moderate to Severe Traumatic Brain Injury

Keywords

recombinant human growth hormone; rhGH; hypoproteinemia; Moderate to Severe Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Change in Total Protein (TP) from Baseline to Weeks 1, 2, 3, and 4

  Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation

• Change in Albumin (ALB) from Baseline to Weeks 1, 2, 3, and 4

  Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation

• Change in Prealbumin (PA) from Baseline to Weeks 1, 2, 3, and 4

  Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation

• Cumulative Amount of Albumin Infused

  Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation

• 24-hour Urine Urea Nitrogen (24h UUN)

  Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.

Study Arms (2)

rhGH Treatment Group

EXPERIMENTAL

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; Other: Standard Care (Treatment as Usual)

Standard Care Group

ACTIVE COMPARATOR

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)

Interventions

Recombinant Human Growth Hormone (rhGH) Injection DRUG

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.

rhGH Treatment Group

Standard Care (Treatment as Usual) OTHER

Participants receive standard clinical care and/or routine observation without recombinant human growth hormone.

Standard Care Group; rhGH Treatment Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Fuyang people's hospital: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• the First Affiliated Hospital of Anhui University of Science and Technology: collaborator

Study Sites (1)

The First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 230036, China

Location

MeSH Terms

Conditions

Brain Injuries; Hypoproteinemia

Interventions

Growth Hormone; Standard of Care; Therapeutics

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Hao Xu

  The First Affiliated Hospital of University of Science and Technology of China

  STUDY CHAIR

Central Study Contacts

Hao Xu, PhD

CONTACT

18019576586; Xuhao2021@ustc.edu.cn

ChunSheng Xia, MD

CONTACT

xiassen@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in parallel to either the intervention group receiving recombinant human growth hormone or the control group receiving standard treatment.

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 19, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): October 30, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)