October 2020

Sunflower Study team collaborate with Bristol Centre for Surgical Research to produce animation

The Sunflower study is a National Institute for Health Research funded, multi-centre, UK-wide, randomised controlled trial looking at whether a subgroup of patients undergoing gallbladder removal surgery should receive a specific type of MRI scan prior to their surgery. This study is managed by Maddie Clout from the Bristol Royal Infirmary hub. 

Members of the Sunflower study team, led by Natalie Blencowe, have recently completed a project with Anni Skilton at The Bristol Centre for Surgical Research to produce a study animation. This animation is aimed at clinicians and healthcare professionals interested in participating in the Sunflower study. 

The animation covers aspects of the study such as the background and rationale, patient eligibility and what is involved for hospitals when participating in the study. 

You can view the animation on YouTube and via the Sunflower study Twitter account @SunflowerStudy 

Cartoon image of surgeon performing gallbladder removal surgery

The Sunflower study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment Programme (project number 16/142/04). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR HTA or the Department of Health. 

Statistical analysis of CARDIOMAN study begins

The BTC are proud to report that, after a huge effort from the study co-ordination team led by study manager Lucy Dabner, the CARDIOMAN study participants have now completed follow up. This means that the analysis of data collected from this complex study is ready to begin.

CARDIOMAN is a double-blind placebo-controlled crossover study investigating the efficacy of bezafibrate, a drug usually used to lower cholesterol, in patients with Barth syndrome. Barth syndrome is a very rare, life-threatening genetic disease affecting <1 in 100,000 people, which affects primarily young males and is caused by abnormal lipids (fats) in the part of a cell called the mitochondria. Those with the syndrome suffer a range of symptoms including cardiac disease, increased occurrence of bacterial infections due to low white blood cell count and poor growth or feeding problems. Exercise intolerance, lethargy and fatigue are seen in all patients and sudden cardiac death can occur at any stage of childhood. Other than supportive care for acute symptoms, there is no specific treatment for Barth syndrome. A disease-specific therapy is required to reduce morbidity, mortality, psychological distress, and disruption of quality of life in Barth syndrome patients and their families.

The CARDIOMAN study recruited 11 participants out of a total UK population of 26 Barth syndrome patients. Participants received both 15 weeks of bezafibrate and 15 weeks of an identical placebo, with a one month period in between with no treatment. The primary outcome measure of the study was exercise tolerance measured by peak oxygen consumption during an exercise test on a static exercise bicycle. A range of clinical and biochemical secondary outcomes were also measured.

The study data has now been collected and checked for accuracy so that data analysis can begin, with results expected in early 2021.

The results will be:

  • Sent to the participants and their families
  • Published in the National Institute of Health Research Efficacy and Mechanisms Evaluation journal
  • Circulated by the Barth Syndrome Trust (UK charity), Barth Syndrome Service (UK clinic based in Bristol) and the Barth Syndrome Foundation (USA charity) to the wider Barth syndrome community
  • Presented to the medical community at national and international conferences

This study is funded by the NIHR Efficacy and Mechanisms (EME) Programme (12/205/56). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.

Study coordinator: Lucy Dabner

GAP Study Update: Cardiac Recruitment Complete

Currently, patients are prescribed opioids such as morphine after surgery to provide pain relief. The GAP study aims to find out whether prescribing the drug gabapentin, alongside opioids and other drugs: 

  • Improves pain control 
  • Leads to fewer side effects overall 
  • Leads to a quicker recovery.  

The study is recruiting patients having cardiac (heart), thoracic (lung) or abdominal (stomach) surgery.   

Recruitment was paused at all sites in March 2020 due to the Covid-19 pandemic, and some sites have since restarted recruitment. Recently, the 500th cardiac patient was recruited completing recruitment to the cardiac specialty. This is a fantastic achievement, and we would like to congratulate everyone involved! Recruitment to the thoracic and abdominal specialties is ongoing and we hope that the numbers in these specialties will pick up soon.   

Despite the pause in recruitment of new patients over the last few months, follow up of participants by phone and by post has continued. We would like to thank all GAP staff and participants as the data completeness and patient response rates have been extremely high recently.    

Dr Ben Gibbison is the Chief Investigator of the GAP study. For more information about the GAP study please visit our website. 

This study is funded by the National Institute for Health Research – Health Technology Assessment Programme (15/101/16). The views and opinions expressed therein are those of the author(s) and not necessarily reflect those of the National Institute of Health Research, NHS, or the Department of Health and Social Care. 

Graph showing the target recruitment rate vs actual recruitment rate