Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection (NCT06977763) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection
104 participantsStarted 2025-07-01
Plain-language summary
The succinylated gelatin 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 injection (trade name: Gelofusine) produced by B. Braun Melsungen AG is licensed ®； 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.
✕. Individuals who have a history of heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as arteriosclerosis) and are deemed unsuitable to participate in this trial by the researchers.
✕. Suffering from severe heart disease, including but not limited to a history of unstable angina, cerebrovascular accident or transient ischemic stroke (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure, severe arrhythmia with poor drug control, requiring mechanical maintenance (such as pacemakers), placement of cardiac stents or New York Heart Association (NYHA) classification ≥ III at the time of screening, abnormal results on echocardiography and/or 12 lead electrocardiogram have clinical significance.
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
✕. Patients who have previously suffered from pheochromocytoma or had poor blood pressure control during screening (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg), and the researchers have determined that they are not suitable to participate in this trial.
✕. Individuals with a history of liver cirrhosis or abnormal liver function during screening and deemed unsuitable for participation in this trial by the 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.
✕. Having any of the following respiratory management risks in the past: 1) history of asthma (such as allergic asthma); 2) People with sleep apnea syndrome.
✕. Previously suffered from hematological disorders such as sickle cell anemia, thalassemia, etc.
✕. Patients with previous or current malignant tumors (excluding non metastatic basal cell carcinoma or squamous cell carcinoma, papillary thyroid carcinoma, and cervical cancer in situ that have been cured for ≥ 5 years and do not require follow-up).