Acute Brain InjuriesPhase 4GH-ABI-RCTNCT07481656
Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT)
A Phase 4 study testing Recombinant Human Growth Hormone (rhGH) Injection in people with Acute Brain Injuries and Moderate to Severe Traumatic Brain Injury, run by Anhui Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Brain Injuries, Moderate to Severe Traumatic Brain Injury
- What is being tested?
- Recombinant Human Growth Hormone (rhGH) Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2026to 30 Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ChunSheng Xia, MD contact
China1 site
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230036
Hao Xu, PhD, 18019576586, Xuhao2021@ustc.edu.cn
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Recombinant Human Growth Hormone (rhGH) Injection, Standard Care (Treatment as Usual)
- Keywords
- recombinant human growth hormone, rhGH, hypoproteinemia, Moderate to Severe Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Hypoproteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Growth Hormone (rhGH) InjectionDrug
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.
Standard Care (Treatment as Usual)Other
Participants receive standard clinical care and/or routine observation without recombinant human growth hormone.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Care (Treatment as Usual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The difference in serum total protein level (g/L) from baseline to Weeks 1, 2, 3, and 4 after treatment initiation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2026
- Study start10 Apr 2026 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Fuyang people's hospital, The First Affiliated Hospital of Bengbu Medical University, the First Affiliated Hospital of Anhui University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Hao Xu, Study chair, The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07481656
- Sponsor's protocol ID
- 2025-KY630
- Acronym
- GH-ABI-RCT
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia
- ClinicalTrials.gov ID
- NCT07481656
- Acronym / sponsor ID
- GH-ABI-RCT / 2025-KY630
- Keywords
- recombinant human growth hormone, rhGH, hypoproteinemia, Moderate to Severe Traumatic Brain Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Fuyang people's hospital, The First Affiliated Hospital of Bengbu Medical University, the First Affiliated Hospital of Anhui University of Science and Technology
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 19 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| rhGH Treatment Group | Experimental | Drug: Recombinant Human Growth Hormone (rhGH) Injection, Other: Standard Care (Treatment as Usual)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. |
| Standard Care Group | Active comparator | Other: Standard Care (Treatment as Usual)Participants receive standard clinical care or routine observation without recombinant human growth hormone, according to usual practice and individual clinical conditions. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Growth Hormone (rhGH) InjectionRecombinant 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. | Drug | rhGH Treatment Group |
| Standard Care (Treatment as Usual)Participants receive standard clinical care and/or routine observation without recombinant human growth hormone. | Other | Standard Care Group, rhGH Treatment Group |
Primary outcome
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.
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.
17 secondary outcomes
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.
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.
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
Glasgow Outcome Scale Extended (GOSE) Score at Week 4
Time frame: At Week 4 (±2 days) after treatment initiation.
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
Change in Hemoglobin in Anemic Subgroup (Hemoglobin < 95 g/L)
Time frame: Baseline, Weeks 1, 2, 3, 4 (±2 days) after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ChunSheng Xia, MD contact
Hao Xu study chair
The First Affiliated Hospital of University of Science and Technology of China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Human Growth Hormone (rhGH) Injection in people with Acute Brain Injuries and Moderate to Severe Traumatic Brain Injury, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Xu, PhD (18019576586, Xuhao2021@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.