Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Large Volume Acute Normovolemic Hemodilution All the participants will undergo Large Volume Acute Normovolemic Hemodilution. |
Procedure: Acute Normovolemic Hemodilution
Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.
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Outcome Measures
Primary Outcome Measures
- Enrollment rate of subjects [Through study completion，about 8 months]
The percentage of patients who completed the study
- Completion rate of acute normovolemic hemodilution [Through study completion，about 8 months]
The percentage of patients who complete large volume of acute normovolemic hemodilution
- Additional blood transfusion beyond transfusion protocol [Through study completion，about 8 months]
Nonstandard blood transfusion
Secondary Outcome Measures
- Rate of perioperative blood transfusion [Through study completion，about 8 months]
The percentage of red blood, fresh frozen plasma and platelet transfusion
- Rate of postoperative cardiac complications [Through study completion，about 8 months]
Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination
- Rate of postoperative pulmonary complications [Through study completion，about 8 months]
Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination
- Rate of postoperative neurological complication [Through study completion，about 8 months]
Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination
- Rate of postoperative renal complication [Through study completion，about 8 months]
Need renal replacement therapy
- Other severe complication [Through study completion，about 8 months]
Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record
Eligibility Criteria
Criteria
Inclusion Criteria:
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Audlt patients ( ≥ 18 years old);
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elective valve surgery under cardiopulmonary bypass;
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Preoperative hemoglobin (Hb) ≥ 12g/dl; (4) Transfusion Risk Understanding Scoring Tool (TRUST) ≥ 2 (possibility of blood transfusion ≥40%).
Exclusion Criteria:
（1）Low body weight (male: <50 kg;Female: < 45kg);（2）preoperative shock；（3）myocardial infarction within 3 months before surgery；（4）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);（5）uncontrolled hypertension;（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）preoperative preparation platelet;（12） contagious or infectious diseases;（13） patient or family members refused to participate in research;（14）refused to infusion of autologous blood or allogeneic blood products
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The second affiliated hospital of Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Study Chair: Min Yan, Doctor, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2019-056