- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03933917
Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery
Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Zhejiang
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Hangzhou, Zhejiang, China, 310000
- The Second Affiliated Hospital of Zhejiang University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Audlt patients ( ≥ 18 years old);
- elective valve surgery under cardiopulmonary bypass;
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Large Volume Acute Normovolemic Hemodilution
All the participants will undergo Large Volume Acute Normovolemic Hemodilution.
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment rate of subjects
Time Frame: Through study completion,about 8 months
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The percentage of patients who completed the study
|
Through study completion,about 8 months
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Completion rate of acute normovolemic hemodilution
Time Frame: Through study completion,about 8 months
|
The percentage of patients who complete large volume of acute normovolemic hemodilution
|
Through study completion,about 8 months
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Additional blood transfusion beyond transfusion protocol
Time Frame: Through study completion,about 8 months
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Nonstandard blood transfusion
|
Through study completion,about 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of perioperative blood transfusion
Time Frame: Through study completion,about 8 months
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The percentage of red blood, fresh frozen plasma and platelet transfusion
|
Through study completion,about 8 months
|
Rate of postoperative cardiac complications
Time Frame: Through study completion,about 8 months
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Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination
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Through study completion,about 8 months
|
Rate of postoperative pulmonary complications
Time Frame: Through study completion,about 8 months
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Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination
|
Through study completion,about 8 months
|
Rate of postoperative neurological complication
Time Frame: Through study completion,about 8 months
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Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination
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Through study completion,about 8 months
|
Rate of postoperative renal complication
Time Frame: Through study completion,about 8 months
|
Need renal replacement therapy
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Through study completion,about 8 months
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Other severe complication
Time Frame: Through study completion,about 8 months
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Including re-operation, re-admission of intensive care unit, multiple organ dysfunction, all cause death according to physical and laboratory examination and medical record
|
Through study completion,about 8 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2019-056
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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