Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate… (NCT06977750) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection
China104 participantsStarted 2025-04-27
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Age range is 18 to 65 years old (including boundary values), with no gender restrictions.
✓. Weight not less than 50 kg, weight not more than 100 kg, body mass index \[BMI=weight (kg)/height 2 (m2)\] within the range of 19.0\~30.0 kg/m2 (including critical values).
✓. Planned elective surgery with an estimated duration of less than 6 hours.
✓. The expected ANH blood collection volume is 10% to 15% of the total blood volume.
✓. Prior to enrollment, the Hb level of the subjects was ≥ 110 g/L.
✓. The American Society of Anesthesiologists (ASA) has a rating of I-III.
✓. Voluntarily participate in this experiment and sign a written informed consent form.
Exclusion criteria
✕. Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to participate in this trial.
✕
What they're measuring
1
Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH
Timeframe: 5 minutes after the completion of ANH compared to immediately before the start of ANH
. Previous indications include heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as a history of arteriosclerosis), and the researchers have determined that they are not suitable to participate in this trial.
✕. Suffering from serious heart diseases, including but not limited to unstable angina, cerebrovascular accidents or transient ischemic stroke (within 6 months before screening), myocardial infarction (within 6 months before screening), New York Heart Association (NYHA) classification ≥ III, congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placing heart stents or abnormal results of echocardiography and/or 12 lead electrocardiogram during screening, has clinical significance.
✕. Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive drugs such as angiotensin-converting enzyme inhibitors/angiotensin II receptor antagonists and potassium sparing diuretics 10 hours before surgery, and the researchers have determined that they are not suitable to participate in this trial.
✕. Individuals with a history of liver cirrhosis or liver dysfunction during screening and deemed unsuitable for surgery by researchers: AST or ALT\>2 times the upper limit of normal values; Albumin level\<35 g/L; Blood bilirubin is greater than 1.5 times the upper limit of normal value.
✕. Patients with abnormal renal function assessment during screening and deemed unsuitable for surgery by researchers: Cr or BUN\>1.5 times the upper limit of normal values.
✕. There are any of the following respiratory management risks during screening: 1) history of asthma (such as allergic asthma), wheezing; 2) Individuals with sleep apnea syndrome;
✕. Hematological disorders such as sickle cell anemia, thalassemia, and pheochromocytoma.