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Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT04369443
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

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 Surgery Acute Normovolemic Hemodilution Procedure: Large volume Acute Normovolemic Hemodilution Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery
Actual Study Start Date : April 24, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
No Intervention: MANH
Experimental: LANH Procedure: Large volume 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.




Primary Outcome Measures :
  1. Volume of allogeneic blood transfusion [ Time Frame: Through study completion,about 8 months ]
    The mean volume of allogeneic blood transfusion


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Rate of postoperative renal complication [ Time Frame: Through study completion,about 8 months ]
    Acute kidney injury or Need renal replacement therapy

  4. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369443


Contacts
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Contact: Yue Ming, Master 15858287132 1120596162@qq.com
Contact: Min Yan, Doctor zryanmin@zju.edu.cn

Locations
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China, Zhejiang
The Second Affiliated Hospital of Zhejiang University anesthesiology department Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Min Yan, Doctor       zryanmin@zju.edu.cn   
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Study Chair: Min Yan, Doctor The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT04369443    
Other Study ID Numbers: 2020-110
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No