Trial Outcomes & Findings for Effects of Microplegia on Transfusion Rates After Cardiac Surgery (NCT NCT05076604)
NCT ID: NCT05076604
Last Updated: 2024-08-06
Results Overview
To determine if use of microplegia results in less peri-operative transfusions compared to diluted 4:1 cardioplegia.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
314 participants
Primary outcome timeframe
Intraoperative (time in operating room), Postoperative (from transfer from operating room to intensive care unit to 30 days)
Results posted on
2024-08-06
Participant Flow
Participants were recruited at a tertiary care academic medical center.
All enrolled patients were randomized.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
157
|
|
Overall Study
COMPLETED
|
136
|
126
|
|
Overall Study
NOT COMPLETED
|
21
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Microplegia on Transfusion Rates After Cardiac Surgery
Baseline characteristics by cohort
| Measure |
Cardioplegia
n=157 Participants
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.
|
Microplegia
n=157 Participants
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.
|
Total
n=314 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.0 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
60.7 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
186 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
148 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
287 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
157 participants
n=5 Participants
|
157 participants
n=7 Participants
|
314 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Intraoperative (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.
Outcome measures
| Measure |
Cardioplegia
n=157 Participants
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.
|
Microplegia
n=157 Participants
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.
|
|---|---|---|
|
Intraoperative and Postoperative Transfusions
Intraoperative Red Blood Cell Transfusion (units)
|
2.43 units of blood per participant
Standard Deviation 3.14
|
2.97 units of blood per participant
Standard Deviation 3.49
|
|
Intraoperative and Postoperative Transfusions
Postoperative Red Blood Cell Transfusion (units)
|
4.42 units of blood per participant
Standard Deviation 6.06
|
3.50 units of blood per participant
Standard Deviation 4.25
|
Adverse Events
Cardioplegia
Serious events: 23 serious events
Other events: 50 other events
Deaths: 11 deaths
Microplegia
Serious events: 19 serious events
Other events: 56 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cardioplegia
n=157 participants at risk
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.
|
Microplegia
n=157 participants at risk
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.
|
|---|---|---|
|
Renal and urinary disorders
Postoperative Acute Kidney Injury
|
7.0%
11/157 • 30 days
|
5.7%
9/157 • 30 days
|
|
Renal and urinary disorders
Postoperative Hemodialysis
|
6.4%
10/157 • 30 days
|
5.1%
8/157 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged Ventilation
|
12.7%
20/157 • 30 days
|
8.9%
14/157 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Tracheostomy
|
1.9%
3/157 • 30 days
|
1.9%
3/157 • 30 days
|
|
Cardiac disorders
Reintervention due to MI
|
0.00%
0/157 • 30 days
|
0.64%
1/157 • 30 days
|
|
Nervous system disorders
Stroke
|
2.5%
4/157 • 30 days
|
1.3%
2/157 • 30 days
|
|
Cardiac disorders
Postoperative ECMO
|
0.64%
1/157 • 30 days
|
1.9%
3/157 • 30 days
|
Other adverse events
| Measure |
Cardioplegia
n=157 participants at risk
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.
|
Microplegia
n=157 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
6.4%
10/157 • 30 days
|
3.2%
5/157 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.7%
9/157 • 30 days
|
3.8%
6/157 • 30 days
|
|
Cardiac disorders
Postoperative Atrial Fibrillation
|
24.2%
38/157 • 30 days
|
29.9%
47/157 • 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place