Effects of Microplegia on Transfusion Rates After Cardiac Surgery

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.

Conditions

• Aortic Valve Disease
• Mitral Valve Disease

Interventions

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.

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.

Sponsors & Collaborators

• Quest Medical, Inc

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Spencer J Melby, MD · Washington University School of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-25

Primary Completion

2023-06-01

Completion

2023-08-01

FDA Drug

Yes

Countries

• United States

Study Locations