Application of Large Volume Acute Normovolemic Hemodilution in Cardiac Surgery

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04369443
• Collaborator: (none)
• Enrollment: 110
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 7.2
• Patients Per Site Per Month: 15.2

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
Cardiac Surgery; Acute Normovolemic Hemodilution	Procedure: Large volume Acute Normovolemic Hemodilution	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Apr 24, 2020
• Anticipated Primary Completion Date: Nov 30, 2020
• Anticipated Study Completion Date: Nov 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Volume of allogeneic blood transfusion [Through study completion，about 8 months]

   The mean volume of allogeneic blood transfusion

Secondary Outcome Measures

1. 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

2. 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

3. Rate of postoperative renal complication [Through study completion，about 8 months]

   Acute kidney injury or Need renal replacement therapy

4. 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

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Second Affiliated Hospital of Zhejiang University anesthesiology department	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

• Study Chair: Min Yan, Doctor, The second affiliated hospital of Zhejiang University hangzhou, Zhejiang, China, 310000

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
• ClinicalTrials.gov Identifier: NCT04369443
• Other Study ID Numbers: 2020-110
• First Posted: Apr 30, 2020
• Last Update Posted: Apr 30, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 30, 2020