NCT06977763

Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection

A Multicenter, Randomized, Double-blind, Positive Controlled Clinical Study on the Efficacy and Safety of Succinylated Gelatin Injection for Acute Isovolumetric Hemodilution (ANH) in Elective Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	succinylated gelatin injection 1	Nanjing Chia-Tai Tianqing Pharmaceutical Company
DRUG	succinylated gelatin injection	Gelofusine

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-11-01
• Completion: 2025-12-01
• First posted: 2025-05-18
• Last updated: 2025-05-18