Effects of Microplegia on Transfusion Rates After Cardiac Surgery

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified June 2024 by Washington University School of Medicine
Sponsor
Washington University School of Medicine
Information Provided by (Responsible Party)
Washington University School of Medicine
Clinicaltrials.gov Identifier
NCT05076604
Other Study ID Numbers:
201801103
First Submitted
October 3, 2021
First Posted
October 12, 2021
Results First Posted
May 31, 2024
Last Update Posted
August 5, 2024
Last Verified
June 2024

ClinicalTrials.gov processed this data on July 2024Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Cardioplegia was first introduced as a method to protect the heart during cardiac surgery in the 1950s (1). Initially, it consisted of a crystalloid solution and in the 1970s Follette and colleagues proposed that blood was the best mode of delivery of cardioplegia as it is rich in nutrients and oxygen (2). Blood has better osmotic, buffering, and antioxidant qualities that are needed by ischemic myocardium. More recent studies comparing blood and crystalloid cardioplegias showed that there was less cardiac edema, and recovery of ventricular function was more rapid with blood based cardioplegia (3). A meta-analysis of over 5000 patients corroborated these findings and showed that blood based cardioplegia reduced the incidence of postoperative low cardiac output syndrome and was associated with less myocardial damage (4).

Standard diluted blood cardioplegia can also be modified to undiluted blood cardioplegia also known as microplegia. To compare the cardioprotection of 4:1 blood:crystalloid cardioplegia to microplegia, McCann et al randomized 20 pigs to either group. Cardiac edema was measured using histologic morphometrics and echocardiogram. It was noted that both edema percentage and left ventricular mass were significantly more decreased in the microplegia group. Furthermore, all animals receiving microplegia were successfully weaned off cardiopulmonary bypass, whereas only 40% of those receiving standard cardioplegia were successfully weaned (5).

More recently, Algarni et al. showed decreased prevalence of low cardiac output syndrome in patients who received microplegia (n=2,630) (6). Another study compared microplegia and standard cardioplegia in patients undergoing coronary artery bypass grafting and found that the microplegia group had lower troponin levels during the post-operative course. Moreover, microplegia resulted in lower transfusion rates and decreased length of hospital stay (7).

A high rate of patients undergoing cardiac surgery require red blood cell transfusions (RBC). Red blood cell transfusions are strongly associated with both infection and ischemic postoperative morbidity, length of stay, increased early and late mortality, and overall hospital costs (8). Given that previous studies have shown that microplegia is associated with less transfusions, it would be reasonable to incorporate this into practice at Washington University.

Condition or DiseaseIntervention/Treatment
Aortic Valve DiseaseMitral Valve Disease
Drug: Cardioplegia SolutionDrug: Microplegic Solution No. 1

Study Design

Study TypeInterventional
Actual Enrollment314 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeSupportive Care
Official TitleEffects of Microplegia on Transfusion Rates After Cardiac Surgery: A Randomized Prospective Analysis
Study Start DateMarch 24, 2019
Actual Primary Completion DateMay 31, 2023
Actual Study Completion DateJuly 31, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Cardioplegia
4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.
Drug: Cardioplegia Solution
The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is: Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia. 4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. Nondiluted microplegia consists of all parts human blood.
Microplegia
Nondiluted microplegia consists of all parts human blood.
Drug: Microplegic Solution No. 1
The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is: Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia. 4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. Nondiluted microplegia consists of all parts human blood.

Outcome Measures

Primary Outcome Measures
  1. Intraoperative and Postoperative Transfusions
    To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Are to undergo non-emergent cardiac surgery
\>18 years of age
Willing and able to provide informed consent
Exclusion Criteria
History of endocarditis
Dialysis-dependent renal failure
Currently on pre-operative mechanical circulatory support (i.e. ECMO, LVAD or intra-aortic balloon pump \[IABP\])
Contraindication to receiving a blood transfusion (i.e. Jehovah's Witness)
Emergency procedures

Contacts and Locations

Sponsors and CollaboratorsWashington University School of Medicine
Locations
Washington University School of Medicine | St Louis Missouri, United States, 63110
Investigators
Principal Investigator: Spencer J Melby, MD, Washington University School of Medicine
Study Documents (Full Text)
Documents provided by Washington University School of MedicineStudy Protocol and Statistical Analysis Plan  March 24, 2019