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Effects of Microplegia on Transfusion Rates After Cardiac Surgery

Effects of Microplegia on Transfusion Rates After Cardiac Surgery: A Randomized Prospective Analysis

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05076604
Enrollment
314
Registered
2021-10-13
Start date
2019-03-25
Completion date
2023-08-01
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Disease, Mitral Valve Disease

Brief summary

This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital. Cardioplegia refers to the method of stopping (arresting) the heart in order to perform heart surgery. However, cardioplegia has also come to refer to the solution to achieve cardiac arrest as well as the machinery in which to deliver the solution. This study will investigate our current Standard Cardioplegia (diluted 4:1 blood cardioplegia) versus Microplegia (undiluted blood cardioplegia) to determine if Microplegia reduces peri-operative blood transfusion rates as compared to Standard Cardioplegia. All forms of cardioplegia will be delivered using the MPS2 Microplegia delivery machine by Quest Medical, Inc. Patients will be randomized to receive undiluted microplegia or standard 4:1 cardioplegia. The patient and the surgeon will be blinded to the randomization. Patients will be followed for 30 days post-operatively (or until their initial standard of care post-operative follow up visit with cardiac surgery if that appointment falls outside of the 30 day post-operative window) for the development of any adverse events as well as documentation of blood products given. We will draw one tube of blood for troponin levels at four time points; 1 draw before surgery (this may be done during the intraoperative period), and 3 draws post-operatively: ICU arrival, 12 hours post-ICU arrival and 24 hours post-ICU arrival. This is to closely monitor the patient for any heart tissue injury.

Detailed 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.

Interventions

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.

DRUGMicroplegic 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.

Sponsors

Quest Medical, Inc
CollaboratorINDUSTRY
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperative and Postoperative TransfusionsIntraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.

Countries

United States

Participant flow

Recruitment details

Participants were recruited at a tertiary care academic medical center.

Pre-assignment details

All enrolled patients were randomized.

Participants by arm

ArmCount
Cardioplegia
4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood. 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.
157
Microplegia
Nondiluted microplegia consists of all parts human blood. 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.
157
Total314

Baseline characteristics

CharacteristicCardioplegiaTotalMicroplegia
Age, Continuous61.0 years
STANDARD_DEVIATION 12.2
60.7 years
STANDARD_DEVIATION 12.8
60.4 years
STANDARD_DEVIATION 13.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
6 Participants7 Participants1 Participants
Race (NIH/OMB)
Black or African American
3 Participants20 Participants17 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
148 Participants287 Participants139 Participants
Region of Enrollment
United States
157 participants314 participants157 participants
Sex: Female, Male
Female
60 Participants128 Participants68 Participants
Sex: Female, Male
Male
97 Participants186 Participants89 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
11 / 1577 / 157
other
Total, other adverse events
50 / 15756 / 157
serious
Total, serious adverse events
23 / 15719 / 157

Outcome results

Primary

Intraoperative and Postoperative Transfusions

To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.

Time frame: Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)

ArmMeasureGroupValue (MEAN)Dispersion
CardioplegiaIntraoperative and Postoperative TransfusionsIntraoperative Red Blood Cell Transfusion (units)2.43 units of blood per participantStandard Deviation 3.14
CardioplegiaIntraoperative and Postoperative TransfusionsPostoperative Red Blood Cell Transfusion (units)4.42 units of blood per participantStandard Deviation 6.06
MicroplegiaIntraoperative and Postoperative TransfusionsIntraoperative Red Blood Cell Transfusion (units)2.97 units of blood per participantStandard Deviation 3.49
MicroplegiaIntraoperative and Postoperative TransfusionsPostoperative Red Blood Cell Transfusion (units)3.50 units of blood per participantStandard Deviation 4.25
Comparison: Intraoperative packed red blood cell transfusionp-value: 0.354t-test, 2 sided
Comparison: Postoperative red blood cell transfusionp-value: 0.314t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026