Acute Normovolemic HemodilutionNCT06977763
Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Injection
A study testing succinylated gelatin injection 1 and succinylated gelatin injection in people with Acute Normovolemic Hemodilution, run by Nanjing Chia-tai Tianqing Pharmaceutical.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Normovolemic Hemodilution
- What is being tested?
- succinylated gelatin injection 1 and succinylated gelatin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Received anemia related treatment, colloidal solution, and/or blood products 14 days before surgery.
- If corticosteroids or nonsteroidal anti-inflammatory drugs cannot be discontinued within 7 days before surgery (or within 5 half lives of the drug, whichever is shorter), or if drugs that affect the subject's blood volume cannot be discontinued within 1 day before surgery (such as mannitol, etc.).
- Individuals who are known to be allergic to any component of the investigational drug; Known to be allergic to meat, especially red meat (mammalian meat) or internal organs; Known individuals who are allergic to lactose - α -1,3-galactose; And subjects with a history of severe allergic reactions (such as urticaria, angioedema, etc.).
- Pregnant or lactating women, as well as male subjects (or their partners) or female subjects who have a pregnancy plan during the study period until 1 month after the last use of medication, or who are unwilling to use at least one medically recognized effective contraceptive measure (such as intrauterine devices or condoms) during the study period until 1 month after the last use of medication.
- Individuals who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;
- Other situations that the researcher deems unsuitable to participate in this experiment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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
- Being tested
- succinylated gelatin injection 1, succinylated gelatin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
succinylated gelatin injection 1Drug
Nanjing Chia-Tai Tianqing Pharmaceutical Company
succinylated gelatin injectionDrug
Gelofusine
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Not described Receives: Drug: succinylated gelatin injection 1 |
| control group | Active comparator | Not described Receives: Drug: succinylated gelatin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH
Measured: 5 minutes after the completion of ANH compared to immediately before the start of ANH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Normovolemic HemodilutionStudies of the same condition, open and under way.
- More trials run by Nanjing Chia-tai Tianqing PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- wangning shangguan, Principal investigator, Second Affiliated Hospital of Wenzhou Medical Universityting li, Principal investigator, Second Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977763
- Sponsor's protocol ID
- HPXMJ-III01
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06977763
- Acronym / sponsor ID
- HPXMJ-III01
- Conditions
- Acute Normovolemic Hemodilution
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: succinylated gelatin injection 1 |
| control group | Active comparator | Drug: succinylated gelatin injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| succinylated gelatin injection 1Nanjing Chia-Tai Tianqing Pharmaceutical Company | Drug | experimental group |
| succinylated gelatin injectionGelofusine | Drug | control group |
Primary outcome
Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH
Time frame: 5 minutes after the completion of ANH compared to immediately before the start of ANH
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
wangning shangguan principal investigator
Second Affiliated Hospital of Wenzhou Medical University
ting li principal investigator
Second Affiliated Hospital of Wenzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing succinylated gelatin injection 1 and succinylated gelatin injection in people with Acute Normovolemic Hemodilution, run by Nanjing Chia-tai Tianqing Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yumeng Zhou (86-025-85109999, yumeng_zhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in stroke volume (SV) 5 minutes after completion of ANH compared to immediately before the start of ANH (time frame: 5 minutes after the completion of ANH compared to immediately before the start of ANH). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.