Actively Recruiting
Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection for Acute Isovolumetric Hemodilution in Elective Surgery
Led by Nanjing Chia-tai Tianqing Pharmaceutical · Updated on 2025-05-18
104
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the clinical equivalence of two formulations of succinylated gelatin electrolyte sodium acetate injection in patients undergoing elective surgery with acute normovolemic hemodilution (ANH). The study compares the changes in stroke volume (SV) between 5 minutes after ANH completion and immediately before its start to assess their effects. The trial is randomized, double-blind, and controlled, conducted by Nanjing Chia-tai Tianqing Pharmaceutical to study effectiveness and safety.
CONDITIONS
Brief 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, any gender
- Weight between 50 and 100 kilograms
- Body mass index between 19.0 and 30.0 kg/m2
- Planned elective surgery with expected duration less than 6 hours
- Expected blood collection volume for ANH between 10% and 15% of total blood volume
- Hemoglobin level at or above 110 g/L before enrollment
- 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
- Heart valve disease, aortic stenosis, or severe peripheral vascular disease deemed unsuitable by researchers
- Serious heart diseases such as unstable angina, recent stroke or myocardial infarction, severe arrhythmia, congestive heart failure, or abnormal heart test results
- Poorly controlled hypertension or inability to stop certain antihypertensive drugs before surgery
- Liver cirrhosis or dysfunction beyond specified limits
- Abnormal kidney function beyond specified limits
- Respiratory risks including asthma or sleep apnea
- Hematological disorders like sickle cell anemia or thalassemia
- High risk of bleeding or coagulation disorders
- Poorly controlled diabetes
- History of malignant tumors except certain cured cases
- Excessive blood volume or fluid overload
- Active uncontrolled infection
- Severe preoperative complications such as pulmonary edema or sepsis
- Electrolyte imbalances considered clinically significant
- Recent major surgeries or unhealed surgical incisions
- Recent anemia-related treatments or vaccines before surgery
- Known allergies to study drug components or related substances
- History of drug abuse
- Inability to stop certain medications before surgery
- Pregnancy, lactation, or unwillingness to use effective contraception
- Participation in other clinical trials within one month
- Other researcher-assessed reasons making participation inappropriate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During elective surgery lasting less than 6 hours
Participants receive succinylated gelatin electrolyte sodium acetate injection during elective surgery for acute isovolumetric hemodilution.
1 treatment visit (in-person)
Trial Site Locations
Total: 1 location
1
Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Actively Recruiting
Research Team
Y
yumeng zhou
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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