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Phase 4 N=314 Randomized Double-blind Supportive Care

Effects of Microplegia on Transfusion Rates After Cardiac Surgery

Aortic Valve Disease · Mitral Valve Disease

Enrolled (actual)
314
Serious AEs
13.4%
Results posted
Aug 2024
Primary outcome: Primary: Intraoperative and Postoperative Transfusions — 2.43; 2.97; 4.42; 3.50 units of blood per participant — p=0.354

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Cardioplegia Solution (Drug); Microplegic Solution No. 1 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Washington University School of Medicine
Primary completion
Jun 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Intraoperative and Postoperative Transfusions
2.43; 2.97; 4.42; 3.50 0.354

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.

Eligibility 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05076604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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