Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 2:38 AM
Study NCT ID:
NCT07481656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT)
Sponsor:
Anhui Provincial Hospital
Organization:
Study Overview
Official Title:
A Multicenter, Randomized Controlled Trial Evaluating Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury and Hypoalbuminemia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GH-ABI-RCT
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: