November 2022

ProMPT 2 reaches full recruitment target

The Trial Team are delighted to announce that ProMPT 2 has now reached its full recruitment target of 240 patients randomised into the study.

ProMPT 2 is an NIHR-funded randomised controlled trial investigating post-operative complications for patients undergoing heart surgery, specifically, coronary artery bypass graft (CABG) surgery.

Research suggests that propofol, widely used as a general anaesthetic, may have a protective effect on the heart. Cardioplegia solution is given to patients to keep the heart still and provide nutrients during heart surgery. This study aims to investigate the efficacy of adding different doses of propofol or saline to the cardioplegia solution during CABG surgery   to reduce post-operative complications.

The study team had anticipated needing an additional 6-months to finish recruitment, but with consistent recruitment over the summer of 2022, the team ended up only needing an additional 2-months extension. Special thanks go out to the cardiac research team at University Hospitals Bristol and Weston NHS Foundation Trust for their amazing efforts in recruiting 90% of ProMPT 2 patients! We could not have reached this milestone without you.

With recruitment now complete, the study enters a 12-month follow-up period, with data cleaning already in progress. The overall study end date is 31/03/2024.

 

This project (EME Project: 15/180/55) is funded by the Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership. The views expressed in this publication are those of the author(s) and not necessarily those of the MRC, NIHR or the Department of Health and Social Care.

 

International Clinical Trials Methodology Conference (ICTMC) – October 2022

The ICTMC is the leading international platform for researchers and practitioners to present the very latest in trials methodology research. The meeting also offers valuable networking and training opportunities. A number of colleagues attended the meeting, presenting posters, abstracts and lightning talks.

Posters

RCTs in follow-up A remote intervention to maintain site engagement and improve data quality during the Covid-19 pandemic

Impact of the COVID 19 pandemic on study participation

Evaluation of the introduction of a remote electronic consent processes in the CO2 study

Delivering COVID-19 Vaccine Trials at Speed The ComFluCOV Experience 

Challenges of emulating a target trial for surgical management of pressure sores

Approaches to address multiplicity in pragmatic RCTs

The impact of PPI in the dissemination of clinical trials results to participants

Assessing the accuracy of routine data sources for identifying operation type in cardiac surgery patients

Integrated Participant Storytelling Presentation: An Innovative Method for Disseminating Complex Participant Stories

Presentations

ComFluCOV

Integrated Participant Storytelling Presentation: An Innovative Method for Disseminating Complex Participant Stories

Abstracts

Approaches to address multiplicity in pragmatic RCTs simulation studies to aid with the design and interpretation of RCTs

Integrated Participant Digital Storytelling

Virtual Clinical Outcome Ascertainment in a Prostate Cancer Treatment Trial

A more efficient approach to randomised controlled trials in primary care using routinely collected practice-level data