Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection

NCT06977763 | Not Yet Recruiting DMC

• 1 other identifier: HPXMJ-III01
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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.

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 group

EXPERIMENTAL

Drug: succinylated gelatin injection 1

control group

ACTIVE COMPARATOR

Drug: succinylated gelatin injection

Interventions

succinylated gelatin injection 1 DRUG

Nanjing Chia-Tai Tianqing Pharmaceutical Company

experimental group

succinylated gelatin injection DRUG

Gelofusine

control group

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.
• 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).
• There is a significant risk of bleeding or coagulation disorders, and the researcher evaluates those who are not suitable to participate in this trial, including but not limited to: a) past/current thrombosis or thromboembolic events; b) Patients who stop using antiplatelet or anticoagulant drugs (such as warfarin and clopidogrel) before surgery and have not reached a half-life of 7 days or more (whichever is shorter), except for aspirin (up to 100 mg/d) and low molecular weight heparin (routine prophylactic use before surgery); 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) When screening, PT extension\>upper limit of normal value for 3 seconds or APTT extension\>upper limit of normal value for 10 seconds, and the researcher evaluates it as unsuitable for surgery; e) PLT\<80 × 109/L during screening.
• Individuals with abnormal renal function assessment during screening and deemed unsuitable for participation in this trial by the researchers: Cr or BUN\>1.5 times the upper limit of normal values.
• Individuals with excessive fluid load during screening (such as systemic edema) and deemed unsuitable for participation in this trial by the researchers.
• There were active infections with poor control during screening, and the researchers deemed it unsuitable to participate in this trial.
• During screening, pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc. are combined.
• Individuals with water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) during screening and deemed clinically significant by the researchers are not suitable to participate in this trial.
• 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.

Sponsors & Collaborators

• Nanjing Chia-tai Tianqing Pharmaceutical: lead

MeSH Terms

Interventions

succinylated gelatin

Study Officials

• wangning shangguan

  The 2nd Affiliated Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

• ting li

  The 2nd Affiliated Hospital of Wenzhou Medical 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: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05