Overview

Effects of Microplegia on Transfusion Rates After Cardiac Surgery

Status:
Recruiting
Trial end date:
2022-02-15
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Washington University School of Medicine
Collaborator:
Quest Diagnostics-Nichols Insitute
Treatments:
Cardioplegic Solutions
Pharmaceutical Solutions
Criteria
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