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

Short name GH-ABI-RCT

NCTNCT07481656Other id2025-KY630

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Not yet recruiting
Phase: Phase 4
Enrollment: 160 participants (estimated)
Sponsor: Anhui Provincial Hospital · Other gov
Design: Randomized · Open label (no masking)
Countries: 1 country
China
Start: 10 Apr 2026 (estimated)
Primary completion: 30 Sept 2027 (estimated)
Completion: 30 Oct 2028 (estimated)
First posted: 19 Mar 2026
Last update posted: 19 Mar 2026
Conditions: Acute Brain Injuries · Moderate to Severe Traumatic Brain Injury

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 4
GH-ABI-RCT
NCT07481656
est. 10 Apr 2026 to est. 30 Oct 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Recombinant Human Growth Hormone (rhGH) InjectionDrug
Standard Care (Treatment as Usual)Other

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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.
Registry description
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.

Secondary outcomes(17)

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
Registry description
The difference in serum total protein level (g/L) from baseline to Weeks 1, 2, 3, and 4 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
Registry description
The difference in serum albumin level (g/L) from baseline to Weeks 1, 2, 3, and 4 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
Registry description
The difference in serum prealbumin level (mg/L) from baseline to Weeks 1, 2, 3, and 4 after treatment initiation.
Cumulative Amount of Albumin Infused
Time frame · Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Registry description
The total amount of exogenous albumin (in grams) administered to the patient from baseline through Weeks 1, 2, 3, and 4 after treatment initiation.
24-hour Urine Urea Nitrogen (24h UUN)
Time frame · Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.
Registry description
The value of 24-hour urine urea nitrogen (mmol/24h or g/24h) measured at Weeks 1, 2, 3, and 4 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
Registry description
The change in the Z-score of plasma IGF-1 level from baseline to Weeks 1, 2, 3, and 4after treatment initiation.
Hemoglobin Level at Weeks 1, 2, 3, and 4
Time frame · At weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Registry description
Hemoglobin concentration (g/L) measured at Weeks 1, 2, 3, and 4 after treatment initiation.
Cumulative Blood Transfusion
Time frame · Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation.
Registry description
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.
Cumulative Incidence and Infections
Time frame · Up to Weeks 2 and 4 (±2 days) after treatment initiation
Registry description
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.
Time to First Infection
Time frame · From treatment initiation to Week 4 (±2 days)
Registry description
The time (in days) from treatment initiation to the onset of the first infection, assessed within the 4-week follow-up period.
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
Registry description
Level of C-reactive protein (CRP, mg/L) as a marker of inflammation, measured at Weeks 1, 2, 3, and 4 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.
Registry description
Total lymphocyte count (×10⁹/L) as a marker of immune status, measured at Weeks 1, 2, 3, and 4 after treatment initiation.
Length of Hospital Stay
Time frame · From the date of hospital admission to the date of discharge for any reason, assessed up to 6 months.
Registry description
The total number of days from hospital admission to discharge for any reason.
Length of Intensive Care Unit (ICU) Stay
Time frame · From the date of ICU admission to the date of ICU discharge, assessed up to 6 months
Registry description
The total number of days spent in the Intensive Care Unit (ICU) during the hospitalization.
Glasgow Outcome Scale Extended (GOSE) Score at Week 4
Time frame · At Week 4 (±2 days) after treatment initiation.
Registry description
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).
Duration of Mechanical Ventilation (Subgroup Analysis)
Time frame · 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
Registry description
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.
Change in Hemoglobin in Anemic Subgroup (Hemoglobin < 95 g/L)
Time frame · Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Registry description
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.

Posted results

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No results are posted for this trial.

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Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 60 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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).

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