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RECRUITING
NCT06977750
NA

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

Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2025-04-27

Completion Date

2025-12-31

Last Updated

2025-05-18

Healthy Volunteers

No

Interventions

DRUG

succinylated gelatin electrolyte sodium acetate injection 1

Nanjing Chia-Tai Tianqing Pharmaceutical Company

DRUG

succinylated gelatin electrolyte sodium acetate injection

Gelaspan

Locations (1)

Third Xiangya Hospital of Central South University

Changsha, Hunan, China