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 Stenosis
- Mitral Valve Disease
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 30 days
30 days
Effects of Microplegia on overall morbidity and mortality during peri-operative period
Microplegia results in less peri-operative transfusions
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
Microplegia
1 of 2
Cardioplegia
1 of 2
Active Control
314 Total Participants · 2 Treatment Groups
Primary Treatment: Microplegia · No Placebo Group · Phase 4
Microplegia
Drug
ActiveComparator Group · 1 Intervention: Microplegic Solution No. 1 · Intervention Types: DrugCardioplegia
Drug
ActiveComparator Group · 1 Intervention: Cardioplegia Solution · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 30 days
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,805 Previous Clinical Trials
2,278,389 Total Patients Enrolled
3 Trials studying Aortic Valve Stenosis
31 Patients Enrolled for Aortic Valve Stenosis
Quest Medical, IncUNKNOWN
Spencer J Melby, MDPrincipal InvestigatorWashington University School of Medicine
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- 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.
- 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.
- 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.
- Brown, W. Morris, III, John L. Jay, John Parker Gott, Alice H. Huang, Pan-Chih, W. Stewart Horsley, Lynne M.A. Dorsey, Sara Katzmark, Robert J. Siegel, and Robert A. Guyton. 1993. “Warm Blood Cardioplegia: Superior Protection After Acute Myocardial Ischemia”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/0003-4975(93)90470-3.
- Algarni, Khaled D., Richard D. Weisel, Christopher A. Caldarone, Manjula Maganti, Katherine Tsang, and Terrence M. Yau. 2013. “Microplegia During Coronary Artery Bypass Grafting Was Associated with Less Low Cardiac Output Syndrome: A Propensity-matched Comparison”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/j.athoracsur.2012.09.056.
- Onorati, Francesco, Francesco Santini, Rajesh Dandale, Grazia Ucci, Kostantinos Pechlivanidis, Tiziano Menon, Bartolomeo Chiominto, Alesssandro Mazzucco, and Giuseppe Faggian. 2013. ““polarizing” Microplegia Improves Cardiac Cycle Efficiency After CABG for Unstable Angina”. International Journal of Cardiology. Elsevier BV. doi:10.1016/j.ijcard.2012.06.099.
- Murphy, Gavin J., Barnaby C. Reeves, Chris A. Rogers, Syed I.A. Rizvi, Lucy Culliford, and Gianni D. Angelini. 2007. “Increased Mortality, Postoperative Morbidity, and Cost After Red Blood Cell Transfusion in Patients Having Cardiac Surgery”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.107.698977.
- Zeng, Jinming, Wenwu He, Zhanli Qu, Yanyan Tang, Qiuxi Zhou, and Bingdong Zhang. 2014. “Cold Blood Versus Crystalloid Cardioplegia for Myocardial Protection in Adult Cardiac Surgery: A Meta-analysis of Randomized Controlled Studies”. Journal of Cardiothoracic and Vascular Anesthesia. Elsevier BV. doi:10.1053/j.jvca.2013.06.005.
- 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.
- 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.
- 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.
- 2019. "Effects of Microplegia on Transfusion Rates After Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05076604.
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