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.
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).
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).
Parallel
Recombinant Human Growth Hormone (rhGH) Injection
DrugRecombinant 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 interventionParticipants receive standard clinical care and/or routine observation without recombinant human growth hormone.
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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
Anhui Provincial Hospital
Lead sponsor
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
This trial is not recruiting at the moment. You can still explore other options:
