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

NCT06977750 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2025-05-18

No results posted yet for this study

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

Interventions

DRUG

succinylated gelatin electrolyte sodium acetate injection 1

Nanjing Chia-Tai Tianqing Pharmaceutical Company

DRUG

succinylated gelatin electrolyte sodium acetate injection

Gelaspan

Sponsors & Collaborators

  • Nanjing Chia-tai Tianqing Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • wen ouyang · Third Xiangya Hospital of Central South University

  • saiying wang · Third Xiangya Hospital of Central South University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-27
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06977750 on ClinicalTrials.gov