Acute Brain Injuries, Moderate to Severe Traumatic Brain Injury
Conditions
Keywords
recombinant human growth hormone, rhGH, hypoproteinemia, Moderate to Severe Traumatic Brain Injury
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.
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
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.
Participants receive standard clinical care and/or routine observation without recombinant human growth hormone.
Sponsors
Anhui Provincial Hospital
Fuyang people's hospital
The First Affiliated Hospital of Bengbu Medical University
the First Affiliated Hospital of Anhui University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study.
Intervention model description
Participants will be randomly assigned in parallel to either the intervention group receiving recombinant human growth hormone or the control group receiving standard treatment.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Plasma Albumin Level from Baseline to Week 2 | Baseline (within 7 days before first treatment) and Week 2 (±2 days) after treatment initiation. | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation | 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 | Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation | 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 | Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation | 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) | Weeks 1, 2, 3, 4 (±2 days) after treatment initiation. | 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 | Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation | 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 | At weeks 1, 2, 3, 4 (±2 days) after treatment initiation | Hemoglobin concentration (g/L) measured at Weeks 1, 2, 3, and 4 after treatment initiation. |
| Cumulative Blood Transfusion | Up to Weeks 1, 2, 3, 4 (±2 days) after treatment initiation. | 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 | Up to Weeks 2 and 4 (±2 days) after treatment initiation | 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 | From treatment initiation to Week 4 (±2 days) | 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 | At weeks 1, 2, 3, 4 (±2 days) after treatment initiation | 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 | At Weeks 1, 2, 3, and 4 (±2 days) after treatment initiation. | 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 | From the date of hospital admission to the date of discharge for any reason, assessed up to 6 months. | The total number of days from hospital admission to discharge for any reason. |
| Length of Intensive Care Unit (ICU) Stay | From the date of ICU admission to the date of ICU discharge, assessed up to 6 months | The total number of days spent in the Intensive Care Unit (ICU) during the hospitalization. |
| Glasgow Outcome Scale Extended (GOSE) Score at Week 4 | At Week 4 (±2 days) after treatment initiation. | 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) | 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 | 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) | Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation | 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. |
Countries
China
Contacts
CONTACTHao Xu, PhD
CONTACTChunSheng Xia, MD
STUDY_CHAIRHao Xu
The First Affiliated Hospital of University of Science and Technology of China
Outcome results
None listed