April 1, 2019Open Access
‘Off pump’ self-expanding injectable tissue valves (IPVR) versus ‘on pump’ conventional tissue valves (PVR) for replacement of the pulmonary valve: trial protocol for a randomised controlled trial (InVITe trial)
Key Result
This is a trial protocol for a randomized controlled trial comparing 'off pump' injectable tissue valves versus 'on pump' conventional tissue valves; no results are available yet.
Study Design
Type
RCT
Blinding
Single-blind
Randomization
1:1
Multicenter
Yes
Structured PICO
Does 'off pump' injectable pulmonary valve replacement reduce post-surgery blood loss in the first 24 hours compared to 'on pump' conventional pulmonary valve replacement in patients with congenital heart disease?
P
Population
Patients aged 12 to 80 years with congenital heart disease requiring pulmonary valve replacement.
I
Intervention
'Off pump' injectable pulmonary valve replacement (self-expanding valves without cardiopulmonary bypass)
C
Comparator
'On pump' conventional pulmonary valve replacement (with cardiopulmonary bypass)
O
Outcome
Difference between the groups with respect to post-surgery blood loss (as measured by chest drain volume) in the first 24 hourssurrogate
This trial protocol outlines a study to determine if off-pump injectable pulmonary valve replacement reduces post-operative blood loss compared to conventional on-pump surgery in patients with congenital heart disease.
Abstract
INTRODUCTION: Patients with congenital heart disease often need repeated operations throughout life to replace the pulmonary valve. Valve replacement with 'injectable' self-expanding valves (which is performed 'off pump' without the use of cardiopulmonary bypass, CPB) may result in quicker recovery and lower risk of major complications than valve replacement with conventional valves (which is performed 'on pump' with the use of CPB). METHODS AND ANALYSIS: We are conducting a multicentre, single-blind randomised controlled trial in patients with congenital heart disease and aged between 12 and 80 years. We will randomise participants in a 1:1 ratio to receive either 'off pump' injectable pulmonary valve replacement or 'on pump' conventional pulmonary valve replacement. The primary outcome will be the difference between the groups with respect to post-surgery blood loss (as measured by chest drain volume) in the first 24 hours. Secondary outcomes will include in-hospital outcomes (intensive care unit stay, inotropic/vasodilator support, chest drain volume in the first 12 hours post-surgery, time of readiness for extubation, blood products used in the first 24 hours post-surgery, time of fitness for discharge, valve and heart function 6 months post-surgery (assessed using cardiovascular magnetic resonance and ECHOCARDIOGRAPHY) and health-related quality of life 6 weeks and 6 months post-surgery. ETHICS AND DISSEMINATION: This trial has been approved by the South West Exeter Research Ethics Committee. Findings will be shared with participating hospitals and disseminated to the academic community through peer reviewed publications and presentation at national and international meetings. Patients will be informed of the results through patient organisations and newsletters to participants. TRIAL REGISTRATION NUMBER: ISRCTN23538073.