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Acute Normovolemic Hemodilution in Complex Cardiac Surgery

About

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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase III

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • baseline chronic kidney disease (CKD) stage 3/above or End-stage renal disease (ESRD) +/- hemodialysis
  • hemodynamically unstable patients including sepsis/recently treated sepsis
  • preoperative extracorporeal membrane oxygenation (ECMO) or high suspicion for postoperative ECMO
  • emergent cases

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Study Stats
Protocol No.
21-000469
Category
Anesthesiology & Perioperative Medicine
Contact
Jennifer Scovotti
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05049590
For detailed technical eligibility, visit ClinicalTrials.gov.