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Completed

NCT Number: NCT03933917

Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Valve Surgery

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.

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Key information

Conditions

Cardiac Valve Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The second affiliated hospital of Zhejiang University

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acute Normovolemic Hemodilution

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Effect of Large Volume Acute Normovolemic Hemodilution on Perioperative Blood Transfusion and Outcomes in Cardiac Valve Surgery

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 1, 2019
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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