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出境医 / 临床实验 / Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

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
Cardiac Valve Surgery Procedure: Acute Normovolemic Hemodilution Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery
Actual Study Start Date : May 27, 2019
Actual Primary Completion Date : April 22, 2020
Actual Study Completion Date : April 22, 2020
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.
Outcome Measures
Primary Outcome Measures :
  1. Enrollment rate of subjects [ Time Frame: Through study completion，about 8 months ]
    The percentage of patients who completed the study

  2. 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

  3. Additional blood transfusion beyond transfusion protocol [ Time Frame: Through study completion，about 8 months ]
    Nonstandard blood transfusion


Secondary Outcome Measures :
  1. Rate of perioperative blood transfusion [ Time Frame: Through study completion，about 8 months ]
    The percentage of red blood, fresh frozen plasma and platelet transfusion

  2. Rate of postoperative cardiac complications [ Time Frame: Through study completion，about 8 months ]
    Including myocardial infarction, heart failure, low cardiac output, pericardial tamponade, severe arrhythmia according to physical and laboratory examination

  3. Rate of postoperative pulmonary complications [ Time Frame: Through study completion，about 8 months ]
    Including moderate and massive pleural effusion, respiratory failure, re-intubation according to physical and laboratory examination

  4. Rate of postoperative neurological complication [ Time Frame: Through study completion，about 8 months ]
    Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination

  5. Rate of postoperative renal complication [ Time Frame: Through study completion，about 8 months ]
    Need renal replacement therapy

  6. Other severe complication [ Time Frame: 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
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Audlt patients ( ≥ 18 years old);
  2. elective valve 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）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
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China, Zhejiang
The second affiliated hospital of Zhejiang University
Hangzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
Layout table for investigator information
Study Chair: Min Yan, Doctor Zhejiang University
Tracking Information
First Submitted Date  ICMJE April 24, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE May 27, 2019
Actual Primary Completion Date April 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Enrollment rate of subjects [ Time Frame: Through study completion，about 8 months ]
    The percentage of patients who completed the study
  • 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
  • Additional blood transfusion beyond transfusion protocol [ Time Frame: Through study completion，about 8 months ]
    Nonstandard blood transfusion
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2019)
  • Rate of perioperative blood transfusion [ Time Frame: Through study completion，about 8 months ]
    The percentage of red blood, fresh frozen plasma and platelet transfusion
  • Rate of postoperative cardiac complications [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Through study completion，about 8 months ]
    Including cerebral hemorrhage, cerebral infarction according to physical and laboratory examination
  • Rate of postoperative renal complication [ Time Frame: Through study completion，about 8 months ]
    Need renal replacement therapy
  • Other severe complication [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery
Official Title  ICMJE Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cardiac Valve Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Large Volume Acute Normovolemic Hemodilution
All the participants will undergo Large Volume Acute Normovolemic Hemodilution.
Intervention: Procedure: Acute Normovolemic Hemodilution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2020) 		74
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2019) 		72
Actual Study Completion Date  ICMJE April 22, 2020
Actual Primary Completion Date April 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Audlt patients ( ≥ 18 years old);
  2. elective valve 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）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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933917
Other Study ID Numbers  ICMJE 2019-056
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor  ICMJE Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Min Yan, Doctor Zhejiang University
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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