BridgeMD
Tests treatment safety and results for Acute Normovolemic Hemodilution
Official title Clinical Study on the Effectiveness and Safety of Succinylated Gelatin Electrolyte Sodium Acetate Injection
ClinicalTrials.gov ID: NCT06977750
What this study is testing
What is succinylated gelatin electrolyte sodium acetate injection 1?
succinylated gelatin electrolyte sodium acetate injection 1 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for acute normovolemic hemodilution.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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 people was ≥ 110 g/L.
You likely can't join if
- Individuals with a history of severe cerebrovascular disease or severe mental illness, who have been deemed unsuitable by the researchers to...
- Previous indications include heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as a history of arteriosclerosis)...
- Suffering from serious heart diseases, including but not limited to unstable angina, cerebrovascular accidents or transient ischemic stroke (within 6...
- Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive...
- Individuals with a history of liver cirrhosis or liver dysfunction during screening and deemed unsuitable for surgery by researchers: AST or ALT\>2...
- Patients with abnormal renal function assessment during screening and deemed unsuitable for surgery by researchers: Cr or BUN\>1.5 times the upper...
See the full eligibility criteria
Who can 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 people 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.
What rules you out
- 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.
- Previous indications include heart valve disease, aortic stenosis, and severe peripheral vascular disease (such as a history of arteriosclerosis), and the researchers have determined that they are not suitable to...
- Suffering from serious heart diseases, including but not limited to unstable angina, cerebrovascular accidents or transient ischemic stroke (within 6 months before screening), myocardial infarction (within 6 months...
- Patients with hypertension have poor blood pressure control (SBP ≥ 160mmHg and/or DBP ≥ 100mmHg), and cannot discontinue long-term antihypertensive drugs such as angiotensin-converting enzyme inhibitors/angiotensin II...
- Individuals with a history of liver cirrhosis or liver dysfunction during screening and deemed unsuitable for surgery by researchers: AST or ALT\>2 times the upper limit of normal values; Albumin level\<35 g/L; Blood...
- Patients with abnormal renal function assessment during screening and deemed unsuitable for surgery by researchers: Cr or BUN\>1.5 times the upper limit of normal values.
- There are any of the following respiratory management risks during screening: 1) history of asthma (such as allergic asthma), wheezing; 2) Individuals with sleep apnea syndrome;
- Hematological disorders such as sickle cell anemia, thalassemia, and pheochromocytoma.
- There is a significant risk of bleeding or coagulation disorders, and the researchers assess that surgery is not suitable, including but not limited to: a) past/current thrombotic or thromboembolic events, or an...
- Diabetes patients with poor control, such as glycosylated hemoglobin ≥ 7%, and the investigator judged that they were not suitable to participate in the trial.
- History of 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...
- Excessive blood volume (such as polycythemia vera) and fluid overload (such as systemic edema).
- There is an active infection with poor control, which the researchers believe makes the people unsuitable to participate in this clinical study.
- Preoperative complications include pulmonary edema, dehydration, burns, intestinal obstruction, critical illnesses such as sepsis, multiple organ failure, respiratory distress syndrome, organ transplantation, shock, etc.
- When screening, there is a water electrolyte imbalance (such as hypercalcemia, hyperkalemia, etc.) and the researcher believes that the abnormality has clinical significance and is not suitable to participate in this...
- 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...
- Received anemia related treatment, colloidal solution, and/or blood products 14 days before surgery.
- Those who have received the vaccine within one month before surgery.
- 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...
- Has a history of drug abuse in the past.
- Patients who cannot discontinue corticosteroids, nonsteroidal anti-inflammatory drugs, cyclosporine, tacrolimus, or succinylcholinergic drugs within 7 days before surgery (or within 5 half lives of the drug, whichever...
- Pregnant or lactating women, as well as male people (or their partners) or female people who have a pregnancy plan or are unwilling to use at least one medically recognized effective contraceptive measure (such as...
- Those who have participated in any other non observational clinical trials and used the study drug or device within one month prior to the trial;
- Participants may not be able to complete this study due to other reasons or may have other reasons deemed inappropriate by the researchers to participate in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Changsha, Hunan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changsha, Hunan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.