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Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC) : study protocol for a randomised controlled trial
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Akowuah, Enoch, Goodwin, Andrew T., Owens, W. Andrew, Hancock, Helen C., Maier, Rebecca, Kasim, Adetayo, Mellor, Adrian, Khan, Khalid, Murphy, Gavin and Mason, James (2017) Manubrium-limited ministernotomy versus conventional sternotomy for aortic valve replacement (MAVRIC) : study protocol for a randomised controlled trial. Trials, 18 . 46. ISSN 1745-6215.
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WRAP_art%3A10.1186%2Fs13063-016-1768-4.pdf - Published Version - Requires a PDF viewer. Available under License Creative Commons Attribution 4.0. Download (1003Kb) | Preview |
Official URL: http://dx.doi.org/10.1186/s13063-016-1768-4
Abstract
Background:
Aortic 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/design:
This 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.
Discussion:
This 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.
Item Type: | Journal Article | ||||||||
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Subjects: | R Medicine > RD Surgery | ||||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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Library of Congress Subject Headings (LCSH): | Aortic valve- -- Surgery, Clinical trials , Heart -- Surgery -- Research | ||||||||
Journal or Publication Title: | Trials | ||||||||
Publisher: | Biomed Central | ||||||||
ISSN: | 1745-6215 | ||||||||
Official Date: | 28 January 2017 | ||||||||
Dates: |
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Volume: | 18 | ||||||||
Article Number: | 46 | ||||||||
Status: | Peer Reviewed | ||||||||
Publication Status: | Published | ||||||||
Access rights to Published version: | Open Access (Creative Commons) | ||||||||
Date of first compliant deposit: | 6 February 2017 | ||||||||
Date of first compliant Open Access: | 6 February 2017 | ||||||||
Funder: | National Institute for Health Research (Great Britain) (NIHR) | ||||||||
Grant number: | Grant Reference Number PB-PG-1112-29035 |
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