Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection

NCT06977750 | Recruiting DMC

• 1 other identifier: HPXMJDJZ-III01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Normovolemic Hemodilution

Outcome Measures

Primary Outcomes (1)

• Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH

  5 minutes after the completion of ANH compared to immediately before the start of ANH

Study Arms (2)

experimental grou

EXPERIMENTAL

Drug: succinylated gelatin electrolyte sodium acetate injection

control group

ACTIVE COMPARATOR

Drug: succinylated gelatin electrolyte sodium acetate injection 1

Interventions

succinylated gelatin electrolyte sodium acetate injection 1 DRUG

Nanjing Chia-Tai Tianqing Pharmaceutical Company

control group

succinylated gelatin electrolyte sodium acetate injection DRUG

Gelaspan

experimental grou

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

Study Sites (1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Study Officials

• wen ouyang

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• saiying wang

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yumeng zhou

CONTACT

86-025-85109999; yumeng_zhou@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2025
• First Posted: May 18, 2025
• Study Start: April 27, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CN (1)