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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.
. 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).