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NCT05076604 · ClinicalTrials.gov registry record · Phase 4

Effects of Microplegia on Transfusion Rates After Cardiac Surgery

A Phase 4 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 4
Development phase
314
Enrollment target

NCT05076604: Completed Phase 4 study, sponsored by Washington University School of Medicine.

NCT05076604 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 314 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05076604, a Phase 4 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 4
Development phase
314 participants
Enrollment target

Study 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.

Primary Outcome

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

Interventions

  • DRUG Cardioplegia Solution
  • DRUG Microplegic Solution No. 1

Trial Details

FieldValue
Enrollment Target 314 participants
Start Date 2019-03-25
Est. Completion 2023-08-01
Phase Phase 4

What the finished NCT05076604 record still lists

NCT05076604 is an interventional study that assigns participants to a tested intervention. The registered 314 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (39% lower).

The record links to 0 conditions, and to 2 interventions - of which Cardioplegia Solution is the first listed.

NCT05076604 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05076604 about?

NCT05076604 is a clinical study titled "Effects of Microplegia on Transfusion Rates After Cardiac Surgery". 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 sur...

What is the current status of trial NCT05076604?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 314 participants. The study started on 2019-03-25. Estimated completion is 2023-08-01.

What interventions are being tested in trial NCT05076604?

The interventions under investigation include: Cardioplegia Solution (DRUG), Microplegic Solution No. 1 (DRUG).

Who is sponsoring clinical trial NCT05076604?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05076604's enrollment target sits among peer trials

314 262nd of 2000 higher than 1,739 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05076604, the US trial registry maintained by the National Library of Medicine. NCT05076604 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.