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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 is a Phase 4 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 314 participants.
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.
Interventions
- DRUG Cardioplegia Solution
- DRUG Microplegic Solution No. 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 314 participants |
| Start Date | 2019-03-25 |
| Est. Completion | 2023-08-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05076604
The ClinicalTrials.gov registry entry for NCT05076604 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 314 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cardioplegia Solution is the first listed.
NCT05076604 reports 0 study locations.
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.
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