Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNanjing Chia-tai Tianqing Pharmaceutical

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • succinylated gelatin injection 1
  • succinylated gelatin injection

Treatment groups

104 Participants
are divided into 2 treatment groups

Locations

This trial has no locations