Effects of Microplegia on Transfusion Rates After Cardiac Surgery

NCT05076604 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 201801103
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Disease; Mitral Valve Disease

Outcome Measures

Primary Outcomes (1)

• Intraoperative and Postoperative Transfusions

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

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

Study Arms (2)

Cardioplegia

ACTIVE COMPARATOR

4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.

Drug: Cardioplegia Solution

Microplegia

ACTIVE COMPARATOR

Nondiluted microplegia consists of all parts human blood.

Drug: Microplegic Solution No. 1

Interventions

Cardioplegia Solution DRUG

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.

Cardioplegia

Microplegic Solution No. 1 DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are to undergo non-emergent cardiac surgery
• \>18 years of age
• Willing and able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Quest Medical, Inc: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

• Follette DM, Fey K, Buckberg GD, Helly JJ Jr, Steed DL, Foglia RP, Maloney JV Jr. Reducing postischemic damage by temporary modification of reperfusate calcium, potassium, pH, and osmolarity. J Thorac Cardiovasc Surg. 1981 Aug;82(2):221-38.

  PMID: 7253686 BACKGROUND

• Fremes SE, Christakis GT, Weisel RD, Mickle DA, Madonik MM, Ivanov J, Harding R, Seawright SJ, Houle S, McLaughlin PR, et al. A clinical trial of blood and crystalloid cardioplegia. J Thorac Cardiovasc Surg. 1984 Nov;88(5 Pt 1):726-41.

  PMID: 6387286 BACKGROUND

• Guru V, Omura J, Alghamdi AA, Weisel R, Fremes SE. Is blood superior to crystalloid cardioplegia? A meta-analysis of randomized clinical trials. Circulation. 2006 Jul 4;114(1 Suppl):I331-8. doi: 10.1161/CIRCULATIONAHA.105.001644.

  PMID: 16820596 BACKGROUND

• McCann UG 2nd, Lutz CJ, Picone AL, Searles B, Gatto LA, Dilip KA, Nieman GF. Whole blood cardioplegia (minicardioplegia) reduces myocardial edema after ischemic injury and cardiopulmonary bypass. J Extra Corpor Technol. 2006 Mar;38(1):14-21.

  PMID: 16637518 BACKGROUND

• Algarni KD, Weisel RD, Caldarone CA, Maganti M, Tsang K, Yau TM. Microplegia during coronary artery bypass grafting was associated with less low cardiac output syndrome: a propensity-matched comparison. Ann Thorac Surg. 2013 May;95(5):1532-8. doi: 10.1016/j.athoracsur.2012.09.056.

  PMID: 23608252 BACKGROUND

• Onorati F, Santini F, Dandale R, Ucci G, Pechlivanidis K, Menon T, Chiominto B, Mazzucco A, Faggian G. "Polarizing" microplegia improves cardiac cycle efficiency after CABG for unstable angina. Int J Cardiol. 2013 Sep 10;167(6):2739-46. doi: 10.1016/j.ijcard.2012.06.099. Epub 2012 Jul 12.

  PMID: 22795715 BACKGROUND

• Murphy GJ, Reeves BC, Rogers CA, Rizvi SI, Culliford L, Angelini GD. Increased mortality, postoperative morbidity, and cost after red blood cell transfusion in patients having cardiac surgery. Circulation. 2007 Nov 27;116(22):2544-52. doi: 10.1161/CIRCULATIONAHA.107.698977. Epub 2007 Nov 12.

  PMID: 17998460 BACKGROUND

• BIGELOW WG, LINDSAY WK, GREENWOOD WF. Hypothermia; its possible role in cardiac surgery: an investigation of factors governing survival in dogs at low body temperatures. Ann Surg. 1950 Nov;132(5):849-66. doi: 10.1097/00000658-195011000-00001. No abstract available.

  PMID: 14771796 RESULT

MeSH Terms

Conditions

Aortic Valve Disease

Interventions

Cardioplegic Solutions

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Matthew Schill
• Organization: Washington University School of Medicine

schillm@wustl.edu

3147470707

Study Officials

• Spencer J Melby, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: October 13, 2021
• Study Start: March 25, 2019
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 6, 2024
• Results First Posted: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)