Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery (NCT02527811) | Clinical Trial Compass
UnknownPhase 4
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
China450 participantsStarted 2015-04
Plain-language summary
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease
2. Explore the efficacy of Ulinastatin use in improving intraoperative hemodynamic instability as well as other post-operative organ recuperation and its impact on hospital stay \& cost
Who can participate
Age range
30 Days – 4 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Children diagnosed with Complex Congenital Heart Disease .
. Hospitalized children, both gender, aged ≥ 30 days to ≤ 4 years.
. Preoperative assessment meet with surgical condition.
. Without signs of Liver, Kidney, and Coagulatory dysfunction.
. Written informed consent form has been signed by the Legal Guardian.
Exclusion criteria
. Patients will accept minimally invasive surgery or palliative surgery, as well as Major Aortopulmonary Collateral Arteries (MAPCAs);
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Dynamic changes of arterial oxygen tension / inspired oxygen fraction (PaO2/FiO2) ratio
Timeframe: Participants will be followed for the duration of ICU, an expected average of 5 days
. Its decided that subject needs to undergo second surgery in a short period of time, or underwent other major surgery.
. Subjects with known hypersensitivity to study medication (Ulinastatin for Injection) or patients with highly allergic history.
. Though meeting the study inclusion criteria, the Legal Guardian reject to sign on informed consent. Or at the discretion of study investigator/coinvestigator that the subjects is not appropriate to be included in the study.