NCT02272621.
Trial name or title | Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement |
Methods |
Study design: open‐label, randomised, controlled trial Duration: 20 months No. of centres: single Location: Sweden Setting: cardiac surgical centre Dates: April 2014 to December 2016 |
Participants | 40 participants scheduled for aortic valve replacement Inclusion criteria: aged ≥ 18 years; severe aortic stenosis defined as aortic valve area of < 1 cm2 or index area of 0.6 cm2/m2 by echocardiography; referred for medically indicated aortic valve replacement; sinus rhythm; provide written informed consent Exclusion criteria: left ventricular ejection fraction < 0.45; presence of any coexisting severe valvular disorder; previous cardiac surgery; urgent or emergent surgery |
Interventions | Partial upper hemi‐sternotomy |
Outcomes | Primary outcomes: interleukin‐6; interleukin‐8; interleukin‐10; tumour necrosis factor‐alpha. All postoperatively at 0 to 3 days |
Starting date | April 2015 |
Contact information | Peter Svenarud, MD, PhD +46 (0) 8 517 708 12 peter.svenarud@karolinska.se |
Notes |