NCT06977750招募中不适用
A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery
Nanjing Chia-tai Tianqing Pharmaceutical1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2025年4月27日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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.
- •There is a significant risk of bleeding or coagulation disorders, and the researchers assess that surgery is not suitable, including but not limited to: a) past/current thrombotic or thromboembolic events, or an increased risk of thrombotic or thromboembolic events; b) Require the use of antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) other than aspirin (up to 100 mg/d); c) Having a history of gastrointestinal, intracerebral hemorrhage, or other events considered severe bleeding, such as bleeding caused by the use of nonsteroidal anti-inflammatory drugs; d) PT prolongation>upper limit of normal value of 3 seconds or APTT prolongation>upper limit of normal value of 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT<80 × 109/L.
- •Diabetes patients with poor control, such as glycosylated hemoglobin ≥ 7%, and the investigator judged that they were not suitable to participate in the trial.
- •History of 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).
- •Excessive blood volume (such as polycythemia vera) and fluid overload (such as systemic edema).
- •There is an active infection with poor control, which the researchers believe makes the subjects unsuitable to participate in this clinical study.
- •Preoperative complications include pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc.
- •When screening, there is a water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) and the researcher believes that the abnormality has clinical significance and is not suitable to participate in this clinical study.
- •Having undergone major surgeries or surgical incisions that have not fully healed within the first 6 months of screening: Major surgeries include but are not limited to any surgeries with significant bleeding risks, prolonged general anesthesia periods, or significant traumatic injuries.
- •Received anemia related treatment, colloidal solution, and/or blood products 14 days before surgery.
- •Those who have received the vaccine within one month before surgery.
- •Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).
- •Has a history of drug abuse in the past.
- •Patients who cannot discontinue corticosteroids, nonsteroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or succinylcholinergic drugs within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter).
- •Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan or are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine device or condom) during the study period until 1 month after the last use of medication.
- •Those who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;
- •Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.
研究组 & 干预措施
experimental grou
Experimental
干预措施: succinylated gelatin electrolyte sodium acetate injection (Drug)
control group
Active Comparator
干预措施: succinylated gelatin electrolyte sodium acetate injection 1 (Drug)
结局指标
主要结局
Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH
时间窗: 5 minutes after the completion of ANH compared to immediately before the start of ANH
次要结局
未报告次要终点
研究者
研究点 (1)
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