Actively Recruiting
Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection
Led by Nanjing Chia-tai Tianqing Pharmaceutical · Updated on 2025-05-18
104
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The succinylated gelatin electrolyte sodium acetate injection (specification: 500 mL: 20 g) developed and produced by Nanjing Chia-tai Tianqing Pharmaceutical. is used as the experimental drug, and the succinylated gelatin electrolyte sodium acetate injection (trade name: Jialeban) produced and licensed by Braun Medical (Suzhou) Co., Ltd ®； Specification: 500 mL: 20 g) is used as a control drug to evaluate the clinical equivalence of two formulations in patients planning elective surgery by comparing the changes in stroke volume (SV) between 5 minutes after completion of ANH and immediately before the start of ANH.
CONDITIONS
Official Title
Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 65 years old, all genders allowed
- Body weight between 50 and 100 kg with BMI from 19.0 to 30.0 kg/m2
- Planned elective surgery lasting less than 6 hours
- Expected blood collection volume during ANH is 10% to 15% of total blood volume
- Hemoglobin level before enrollment is at least 110 g/L
- American Society of Anesthesiologists (ASA) rating I to III
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of severe cerebrovascular disease or severe mental illness deemed unsuitable
- History of heart valve disease, aortic stenosis, or severe peripheral vascular disease
- Serious heart diseases including unstable angina, recent stroke or myocardial infarction within 6 months, NYHA class III or higher heart failure, severe arrhythmia requiring mechanical support, abnormal heart test results
- Poorly controlled hypertension with inability to stop certain antihypertensive drugs before surgery
- History of liver cirrhosis or liver dysfunction with abnormal liver tests
- Abnormal kidney function with elevated creatinine or BUN
- Respiratory risks including asthma or sleep apnea syndrome
- Hematological disorders like sickle cell anemia or thalassemia
- Significant bleeding or coagulation disorders, or use of certain blood-thinning drugs besides low-dose aspirin
- Poorly controlled diabetes with high glycosylated hemoglobin
- History of malignant tumors except certain cured cancers
- Excessive blood volume or fluid overload
- Active uncontrolled infections
- Preoperative complications like pulmonary edema, sepsis, organ failure, or shock
- Clinically significant electrolyte imbalances
- Recent major surgeries or unhealed surgical wounds within 6 months
- Anemia treatment, colloids, or blood products within 14 days before surgery
- Vaccination within one month before surgery
- Known allergies to investigational drug components or related substances
- History of drug abuse
- Inability to stop certain medications before surgery
- Pregnant or lactating women, or those unwilling to use effective contraception
- Participation in other clinical trials within one month prior
- Other conditions making participation unsuitable as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
yumeng zhou
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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