Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery (NCT04369443) | Clinical Trial Compass
CompletedNot Applicable
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
China110 participantsStarted 2020-05-01
Plain-language summary
The application of acute Normovolemic Hemodilution in cardiac surgery can effectively reduce perioperative blood transfusion, reduce postoperative complications and mortality, and is a low-cost, operable and effective blood protection measure.For the application of Acute Normovolemic Hemodilution in heart surgery, we still face an urgent problem: to what extent can Acute Normovolemic Hemodilution achieve better "blood saving effect", that is, whether a large number of Acute Normovolemic Hemodilution can reduce perioperative blood transfusion to a greater extent
Who can participate
Age range
18 Years – 75 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:
* (1)18-75years old;(2)elective cardiac surgery under cardiopulmonary bypass; (3)Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).
Exclusion Criteria:
* (1)congenital heart disease、Cardiac tumor、aortic dissection、heart transplantation(2)Low body weight(\<50 kg);(3)preoperative shock;(4)myocardial infarction within 3 months before surgery;(5)ischemic heart disease;Left main coronary artery stenosis \>70%;Severe aortic stenosis (area \< 0.7cm2);Severe changes in left ventricular function (ejection fraction \<30%, requiring vasoactive agents to assist circulation);(6)severe carotid artery stenosis (\>70% or with symptoms);(7) kidney failure (blood creatinine level \>442 mmol/L) or dialysis treatment;(8) serum albumin level (ALB) is less than 25 g/L.(9) international standardized ratio (INR) \>1.5 or platelet count \<100 103/mm3;(10)Inherited/acquired coagulation function defect;(11)contagious or infectious diseases;(12) patient or family members refused to participate in research;(13)refused to infusion of autologous blood or allogeneic blood products
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
Volume of allogeneic blood transfusion
Timeframe: Through study completion,about 8 months
Trial details
NCT IDNCT04369443
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University