Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement MAVRIC: study protocol for a randomised controlled trialReportar como inadecuado




Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement MAVRIC: study protocol for a randomised controlled trial - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Trials

, 18:46

First Online: 28 January 2017Received: 14 March 2016Accepted: 21 December 2016DOI: 10.1186-s13063-016-1768-4

Cite this article as: Akowuah, E., Goodwin, A.T., Owens, W.A. et al. Trials 2017 18: 46. doi:10.1186-s13063-016-1768-4

Abstract

BackgroundAortic valve replacement is one of the most common cardiac surgical procedures performed worldwide. Conventional aortic valve replacement surgery is performed via a median sternotomy; the sternum is divided completely from the sternal notch to the xiphisternum. Minimally invasive aortic valve replacement, using a new technique called manubrium-limited ministernotomy, divides only the manubrium from the sternal notch to 1 cm below the manubrio-sternal junction.

More than one third of patients undergoing conventional sternotomy develop clinically significant bleeding requiring post-operative red blood cell transfusion. Case series data suggest a potentially clinically significant difference in red blood cell transfusion requirements between the two techniques. Given the implications for National Health Service resources and patient outcomes, a definitive trial is needed.

Methods-designThis is a single-centre, single-blind, randomised controlled trial comparing aortic valve replacement surgery using manubrium-limited ministernotomy intervention and conventional median sternotomy usual care. Two hundred and seventy patients will be randomised in a 1:1 ratio between the intervention and control arms, stratified by baseline logistic EuroSCORE and haemoglobin value. Patients will be followed for 12 weeks from discharge following their index operation. The primary outcome is the proportion of patients who receive a red blood cell transfusion post-operatively within 7 days of surgery. Secondary outcomes include red blood cell and blood product transfusions, blood loss, re-operation rates, sternal wound pain, quality of life, markers of inflammatory response, hospital discharge, health care utilisation, cost and cost effectiveness and adverse events.

DiscussionThis is the first trial to examine aortic valve replacement via manubrium-limited ministernotomy versus conventional sternotomy when comparing red blood cell transfusion rates following surgery. Surgical trials present significant challenges; strengths of this trial include a rigorous research design, standardised surgery performed by experienced consultant cardiothoracic surgeons, an agreed anaesthetic regimen, patient blinding and consultant-led patient recruitment. The MAVRIC trial will demonstrate that complex surgical trials can be delivered to exemplary standards and provide the community with the knowledge required to inform future care for patients requiring aortic valve replacement surgery.

Trial registrationInternational Standard Randomised Controlled Trial Number ISRCTN ISRCTN29567910. Registered on 3 February 2014.

KeywordsAortic valve replacement AVR Manubrium-limited ministernotomy Minimally invasive aortic valve replacement Sternotomy Red blood cell transfusion Inflammatory response AbbreviationsACTactivated clotting time

AEadverse event

APTTactivated partial thromboplastin time

APTTRactivated partial thromboplastin time ratio

AVRAortic valve replacement

CEACscost-effectiveness acceptability curves

CICUCardiac Intensive Care Unit

CPBcardiopulmonary bypass

DCTUDurham Clinical Trials Unit

DMCData Monitoring Committee

e-CRFselectronic Case Report Forms

FEV1forced expiratory volume

FFPFresh frozen plasma

FVCforced vital capacity

GCPGood Clinical Practice

GPGeneral Practitioner

Hbhaemoglobin

ICERincremental cost-effectiveness ratio

ICHInternational Conference on Harmonisation

INRInternational normalized ratio

JCUHThe James Cook University Hospital

NHSNational Health Service

NIHRNational Institute for Health Research

PTprothrombin time

PTRprothrombin time ratio

QALY quality-adjusted life year

RBCRed Blood Cell

RfPBResearch for Patient Benefit

SAEserious adverse events

SIRsystemic inflammatory response

SPIRITStandard Protocol Items: Recommendations for Interventional Trials

TEGThromboelastography

TMGTrial Management Group

TOEtransoesophageal echocardiogram

TSCTrial Steering Committee

TXAtranexamic acid

Electronic supplementary materialThe online version of this article doi:10.1186-s13063-016-1768-4 contains supplementary material, which is available to authorized users.





Autor: Enoch Akowuah - Andrew T. Goodwin - W. Andrew Owens - Helen C. Hancock - Rebecca Maier - Adetayo Kasim - Adrian Mellor -

Fuente: https://link.springer.com/







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