Acute Normovolemic Hemodilution in Complex Cardiac Surgery

NCT05049590 | Completed Phase 3 FDA Drug

• 1 other identifier: 21-000469
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative bleeding in cardiac surgery is a frequent complication, and cardiac surgery utilizes 15-20% of the national blood supply. Packed red blood cells (pRBCs) are associated with worse short and long term outcomes. For each unit transfused, there is an additive risk of mortality (death) and cardiac adverse events. Despite current guidelines and numerous approaches to bleeding reduction, \>50% of the patients undergoing cardiac surgery receive transfusions. Acute normovolemic hemodilution (ANH), a blood conservation technique that removes whole blood from a patient immediately prior to surgery, could be a valuable method to reduce transfusion in complex cardiac surgery. At the University of California, Los Angeles (UCLA), ANH is routinely utilized in patients who refuse allogenic blood transfusions such as Jehovah's Witnesses. ANH has been shown to be safe with minimal risk to patients. ANH has been studied in simple cardiac surgery, such as coronary artery bypass grafting, however it has not been studied in complex cardiac surgery, such as aortic surgery and adult congenital heart disease. ANH has been demonstrated to reduce pRBC transfusion in lower risk cardiac surgery without any significant complications. Complex heart surgery utilizes more blood products. This study could identify the benefits of ANH in a higher risk surgical group.

Conditions

Cardiac Surgery; Acute Kidney Injury; Congenital Heart Disease; Aortic Surgery

Keywords

acute normovolemic hemodilution; complex cardiac surgery; transfusions; acute kidney injury

Outcome Measures

Primary Outcomes (3)

• Packed red blood cells (pRBC)

  Total transfusion of pRBC units administered 24 hours post-operatively.

  24 hours

• Packed red blood cells (pRBC)

  Total transfusion of pRBC units administered 48 hours post-operatively.

  48 hours

• Packed red blood cells (pRBC)

  Total transfusion of pRBC units administered 72 hours post-operatively.

  72 hours

Secondary Outcomes (50)

• Maximum Intraoperative Vasoactive-Inotropic Score

  Conclusion of intraoperative procedure

• Maximum 24 Hour Vasoactive-Inotropic Score

  24 hours

• Maximum 48 Hour Vasoactive-Inotropic Score

  48 hours

• Maximum 72 Hour Vasoactive-Inotropic Score

  72 hours

• Acute Kidney Injury (AKI)

  72 hours

Study Arms (2)

Intervention Group

EXPERIMENTAL

Perform blood conservation in the operating room (OR).

Biological: Acute normovolemic hemodilution (ANH)

Control Group

NO INTERVENTION

Blood conservation will not be performed in the OR.

Interventions

Acute normovolemic hemodilution (ANH) BIOLOGICAL

A blood conservation technique that removes whole blood (\~8-10cc/kg) from a patient in the operating room prior to incision.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients presenting for elective cardiac surgery
• Surgical procedures to include:
• Redo surgery
• Adult congenital heart disease surgery (ACHD)
• Aortic surgery including aortic surgery requiring deep hypothermic circulatory arrest

You may not qualify if:

• low risk cardiac surgery
• cardiac surgery not requiring cardiopulmonary bypass
• baseline anemia (Hgb \< 13 for men and 12 for women)
• post-dilution Hct \< 21-24 (basis for this is increased risk of AKI on CPB with Hct 21-22)
• preop treatment for anemia
• high-risk ischemia lesions (critical left main, multi-vessel disease, active/recent chest pain, unstable angina, presence of a balloon pump, recent history of myocardial infarction (MI) either non-ST elevation MI (NSTEMI) / ST-elevation MI (STEMI), regional wall motion abnormalities on echo)
• low left ventricular systolic function (LVEF \< 35-40%) - decompensated heart failure
• Hypertrophic obstructive cardiomyopathy (HOCM) patients with significant left ventricular outflow tract (LVOT) gradients
• history of recent blood transfusion
• history of recent gastrointestinal (GI) bleed
• patient refusal to participate in the study
• severe aortic stenosis (AS) with reduced LVEF
• pulmonary hypertension
• underlying significant liver disease impairing synthetic function (elevated PT/INR or PTT) at baseline
• clotting disorders, inherited or acquired or iatrogenic coagulopathy (i.e. thrombocytopenia, pancytopenia)

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center, Department of Anesthesiology & Perioperative Medicine

Los Angeles, California, 90095, United States

Location

Related Publications (2)

• Barile L, Fominskiy E, Di Tomasso N, Alpizar Castro LE, Landoni G, De Luca M, Bignami E, Sala A, Zangrillo A, Monaco F. Acute Normovolemic Hemodilution Reduces Allogeneic Red Blood Cell Transfusion in Cardiac Surgery: A Systematic Review and Meta-analysis of Randomized Trials. Anesth Analg. 2017 Mar;124(3):743-752. doi: 10.1213/ANE.0000000000001609.

  PMID: 27669554 BACKGROUND

• Zhou ZF, Jia XP, Sun K, Zhang FJ, Yu LN, Xing T, Yan M. Mild volume acute normovolemic hemodilution is associated with lower intraoperative transfusion and postoperative pulmonary infection in patients undergoing cardiac surgery -- a retrospective, propensity matching study. BMC Anesthesiol. 2017 Jan 26;17(1):13. doi: 10.1186/s12871-017-0305-7.

  PMID: 28122491 BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lorraine Lubin, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2021
• First Posted: September 20, 2021
• Study Start: February 28, 2022
• Primary Completion: May 22, 2023
• Study Completion: June 22, 2023
• Last Updated: June 5, 2024

Record last verified: 2024-05

Locations

US (1)