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Procedure

Cardioplegia for Aortic Valve Disease

Phase 4

Recruiting

Led By Spencer J Melby, MD

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial will test whether undiluted microplegia reduces transfusion rates in patients after planned heart surgery, as compared to standard 4:1 cardioplegia.

Eligible Conditions

Aortic Valve Disease
Aortic Valve Stenosis
Mitral Valve Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effects of Microplegia on overall morbidity and mortality during peri-operative period

Microplegia results in less peri-operative transfusions

Trial Design

2Treatment groups

Active Control

Group I: CardioplegiaActive Control1 Intervention

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

Group II: MicroplegiaActive Control1 Intervention

Nondiluted microplegia consists of all parts human blood.

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Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,935 Previous Clinical Trials

2,299,493 Total Patients Enrolled

Quest Medical, IncUNKNOWN

Spencer J Melby, MDPrincipal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Microplegia a safe and effective treatment option for patients?

"The safety rating of Microplegia is 3, as this treatment has been approved by the Phase 4 medical trial."

Answered by AI

How many participants are contributing to this clinical research?

"Affirmative. The information on clinicaltrials.gov suggests that this research venture, which was initially posted in March 2019, is presently searching for participants. A total of 314 patients need to be enrolled from a single medical facility."

Answered by AI

Are researchers in this study still accepting enrollees?

"Affirmative. Clinicaltrials.gov lists this clinical trial as actively recruiting patients, with 314 participants needed from a single site since its March 25th 2019 posting date and most recent update on September 13th 2022."

Answered by AI

Recent research and studies

Journal of the American College of CardiologyJournal

Myocardial Protection During Surgical Coronary Reperfusion

Rosenkranz, Eliot R., and Gerald D. Buckberg. 1983. “Myocardial Protection During Surgical Coronary Reperfusion”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/s0735-1097(83)80135-1.

CirculationJournal

Is Blood Superior to Crystalloid Cardioplegia?

Guru, Veena, John Omura, Abdullah A. Alghamdi, Richard Weisel, and Stephen E. Fremes. 2006. “Is Blood Superior to Crystalloid Cardioplegia?”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.105.001644.

Annals of SurgeryJournal

Its Possible Role in Cardiac Surgery

Bigelow, W. G., W. K. Lindsay, and W. F. Greenwood. 1950. “Its Possible Role in Cardiac Surgery”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000658-195011000-00001.

The Annals of Thoracic SurgeryJournal