Recently Published Trials

Study Type: Observational
Phase: N/A
Location: Single Centre - St Bartholomew's Hospital
Objective: The overall aim of this study is to describe and explore the recovery process of patients undergoing cardiac surgery during the covid-19 pandemic.

More Details: Patient Recovery From Heart Surgery During the Covid-19 Pandemic (CardiacCovid) (NCT04366167)

Study type: Interventional
Phase: N/A
Location: Single Centre  – Guy's and St Thomas' NHS Foundation Trust
Objective: Primary objective To determine the feasibility of delivery of a randomised control trial. Secondary objective (s) To determine baseline outcome data that may be used to power a randomised control trial.

More Details: POWER: PrehabilitatiOn Workshop and Mentored Exercise Programme in Patients Having Elective Aortic Aneurysm Repair (POWER) (NCT04169217)

Study type: Interventional
Phase: Feasibility
Location: Single Centre  – James Cook University Hospital
Objective: The current study will investigate whether it is possible to utilise ERP bundles in the population of cardiac surgery patients at James Cook Hospital, with a view to rolling out a full ERP service. Secondary study outcomes will be patient-centred, including; pain scores, nausea and vomiting rates and time taken to return to normal function.

More Details: Enhanced Recovery After Cardiac Surgery (ERAS) (NCT03859102)

Study type: Observational
Phase: N/A
Location: Single Centre  – Royal Papworth Hospital
Objective: Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.

More Details: Quality of Life After Cardiac Surgery (QUACS) (NCT04231461)

Study type: Interventional
Phase: 4
Location: Multi Centre  – St Thomas' Hospital; Kings College Hospital NHS Foundation Trust
Objective: The objective of this research proposal is to find out whether comparing the two different anaesthetic maintenance techniques (Propofol vs volatile anaesthetics) in adult patients undergoing heart surgery is practical for the anaesthetist treating the patients and whether it is feasible for the research team to recruit patients and follow them up after the operation.

More Details: Comparison Between Propofol and Inhalational Anaesthetic Agents on Cardiovascular Outcomes Following Cardiac Surgery (COPIA) (NCT04039854)

Study type: Interventional
Phase: 2
Location: Multi Centre  (31) – Derriford Hospital
Objective: This is a multi-center, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study to evaluate the efficacy and safety of botulinum toxin type A (AGN-151607) injections into the epicardial fat pads, foci of ganglionic plexi, to prevent Post-Operative Atrial Fibrillation (POAF) in patients undergoing open-chest cardiac surgery.

More Details: Botulinum Toxin Type A (AGN-151607) for the Prevention of Post-operative Atrial Fibrillation in Patients Undergoing Open-chest Cardiac Surgery (NOVA) (NCT03779841)

Study type: Observational
Phase: N/A
Location: Single Centre – St Bartholomew's hospital (Barts NHS trust)
Objective: To identify determinants of 'good and bad recovery' from ICUAW and build knowledge around the timing of these processes. Also, the investigators want to discover the effects of ICUAW on physical function and HRQoL following aortic surgery.

More Details: Muscle Recovery Following Aortic Surgery Induced ICUAW. (VARIANCE) (NCT03714399)

Study type: Interventional
Phase: N/A
Location: Single Centre – Barts Health NHS Trust
Objective: A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive coronary angiography. Invasive coronary procedures in patients with bypass grafts can be more complicated due to the variation in bypass graft ostia. This can lead to longer procedure times, with higher doses of contrast and radiation and more discomfort for the patient. The aim of this study is to see if the use of computed tomography cardiac angiography (CTCA) in patients with previous bypass grafts prior to invasive coronary angiography will help make their procedure safer and quicker.

More Details: Randomised Controlled Trial to Assess Whether Computed Tomography Cardiac Angiography Can Improve Invasive Coronary Angiography in Bypass Surgery Patients (BYPASS-CTCA) (NCT03736018)

Study type: Interventional
Phase: 2
Location: Multi Centre (2) – Southampton General Hospital, Southampton
Objective: This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery.

More Details: Effects of Prolonged Delivery of Nitric Oxide Gas on Plasma Reduction-Oxidation Reactions in Cardiac Surgical Patients (NCT04022161)

Study type: Interventional
Phase: N/A
Location: Single Centre – Glenfield Hospital, Leicester
Objective: The PRE-OP ENERGY Trial proposes to test the overarching hypothesis that a pre-surgery high energy diet will protect patients against organ damage during cardiac surgery with cardiopulmonary bypass.

More Details: The PRE-OP ENERGY Trial (NCT04015973)

Study type: Interventional
Phase: 1b/2
Location: Single Centre – Glenfield Hospital, Leicester
Objective: The Val-CARD trial aims to answer the question: "Does the drug sodium valproate reduce complications affecting the heart and kidneys in patients having heart operations?"

More Details: The Val-CARD Trial (NCT03825250)

Study type: Interventional
Phase: 2
Location: Single Centre - St Bartholomew's Hospital, London
Objective: This pilot study will investigate the feasibility of delivering the different components of the trial, so that investigators can determine if it's feasible to move to a future large trial that will aim to compare the efficacy and safety of FFP versus PCC in adult patients who are actively bleeding during cardiac surgery.

More Details: Trial of PCC Versus FFP in Patients Undergoing Heart Surgery (NCT03715348)

Study type: Interventional
Phase: N/A
Location: Multi Centre.
Objective: The aim of the MARS2 study is to compare surgery - (extended) pleurectomy decortication - with no surgery with respect to overall survival, cost-effectiveness and quality of life. Patients will be followed up by phone at regular intervals for 2 years. Patients will be asked to complete and return a Quality of Life Questionnaire at these time points. MARS 2 also includes an optional 'Information study', where consenting patients may be interviewed or have their consultations audio-recorded. The aim of the Information study is to explore how a patient makes a decision to take part in research or not, with the overall aim of improving recruitment to clinical trials.

More Details: Mesothelioma and Radical Surgery 2 (MARS2) (NCT02040272)

Study type: Interventional
Phase: N/A
Location: Multi Centre.
Objective: The VIOLET study will compare the effectiveness, cost-effectiveness and acceptability of VATS lobectomy versus open surgery for treatment of lung cancer and will test the hypothesis that VATS surgery is superior to open surgery with respect to self-reported physical function five weeks after randomisation (approx. one month after surgery). Specific objectives are to estimate: A. The difference between groups in the average self-reported physical function at five weeks. B. The difference between groups with respect to a range of secondary outcomes including assessment of efficacy (hospital stay, pain, proportion and time to uptake of chemotherapy), measures of safety (adverse health events), oncological outcomes (proportion of patients upstaged to pN2 disease and disease free survival) and overall survival. C. The cost effectiveness of VATs and open surgery.

More Details: VIdeo Assisted Thoracoscopic Lobectomy Versus Conventional Open LobEcTomy for Lung Cancer (VIOLET) (NCT03521375)

Study type: Observational
Phase: N/A
Location: Multi Centre (2) – Barts Health NHS Trust; James Cook University Hospital.
Objective: To examine the variability of change in exercise capacity and health-related quality of life (HRQOL) between those who receive thoracotomy V RATS. To compare the difference in post-operative physical activity (step and activity count), across 7 days, in those who receive thoracotomy V RATS. To explore the manner in which patients appraise their experience of undergoing RATS.

More Details: Exploring Robotic-assisted Thoracic Surgery for Lung Cancer (ROSE) (NCT03658083)

Study type: Interventional
Phase: N/A
Location: Multi Centre (5) – Royal Brompton Hospital, Glenfield Hospital, St Bartholomew’s Hospital, Northern General Hospital, Golden Jubilee National Hospital.
Objective: The aim of this study is to evaluate the relative effectiveness and value of two options currently available for the treatment of COPD patients with a heterogeneous pattern of emphysema. These are lung volume reduction surgery (LVRS) and the bronchoscopic placement of endobronchial valves (BLVR).

More Details: CELEB: Lung volume reduction in COPD - surgery vs endobronchial valves (ISRCTN19684749)

Study type: Interventional
Phase: N/A
Location: Multi Centre.
Objective: The trial's hypothesis is that in adult patients undergoing elective open thoracotomy, the use of paravertebral blockade for pain relief at or around the time of surgery reduces both the number of people reporting chronic pain and the persistence of chronic pain at six months by at least 10%, compared with the use of thoracic epidural block. To detect this difference a total of 1026 patients will be recruited from approximately 20 UK hospitals.

More Details: The Effectiveness of ThOracic Epidural and Paravertebral Blockade In Reducing Chronic Post- Thoracotomy Pain: 2 (TOPIC-2) (NCT03677856)

Study type: Interventional
Phase: N/A
Location: Multi Centre (5).
Objective: Project MURRAY is a trial comparing the effectiveness of personalised integrated smoking cessation delivered by trained health-care practitioners in the thoracic surgical pathway, and is a three part package of behaviour interventions and pharmacotherapy as per National Institute of Clinical Excellence (NICE)/ National Centre for Smoking Cessation Training (NCSCT) guidance which is supported by an adjunct web-based application. This is a pilot study to evaluate feasibility of a substantive trial and study processes in 5 adult thoracic centres including the trial coordinating site at the University Hospitals Birmingham NHS Foundation Trust. This is a multicentre feasibility study, with aim for equal weighting between the two arms of the integrated smoking cessation and an observation only group of usual care.

More Details: Smoking Cessation in the Surgical Pathway Before Major Lung Surgery (MURRAY) (NCT04190966)

Study type: Interventional
Phase: N/A
Location: Multi Centre: Queen's Medical Centre, The James Cook University Hospital, Morriston Hospital, John Radcliffe Hospital, Queen Elizabeth Hospital, Royal London Hospital, Derriford Hospital, Aintree University Hospital.
Objective: The aim of this study is to compare rib fixation with plates and screws to the supportive treatments currently available in the NHS. Participants are randomly allocated to receive either supportive treatments, as is the standard care, or to also undergo an operation to stabilise their rib fractures. Patient outcomes (survival after the injury and quality of life, among other things) and also the cost of treatment to the NHS are measured up until study completion at 12 months.

More Details: The Operative Rib Fixation (ORiF) study (ISRCTN10777575)

Study type: Interventional
Phase: N/A
Location: Single Centre: University Hospitals Birmingham.
Objective: The aim of this study is to compare serratus anterior plane block with usual care versus usual care in adult patients with multiple (>3) rib fractures following blunt thoracic trauma recruited within 72 hours from admission.

Study type: Interventional
Phase: N/A
Location: Single Centre – Bristol Royal Hospital for Sick Children.
Objective: The principal hypothesis is that using lower levels of oxygen during cardiopulmonary bypass will reduce the levels of re-oxygenation injury to paediatric patients, measured both in terms of clinical outcomes (e.g., length of post-operative hospital stay and type of care required) and in long term behavioural outcomes (measured preoperatively and 3 and 12 months post-operatively using the Bayley III Infant Development Scales).

More Details: A randomised controlled trial to compare normoxic versus standard cardiopulmonary bypass in cyanotic children undergoing cardiac surgery (OXIC-2) (ISRCTN81773762)

Study type: Interventional
Phase: N/A
Location: Single Centre – Bristol Royal Hospital for Sick Children.
Objective: Congenital heart disease is not uncommon and morbidity following cardiac surgery in children remains significant. Surgical repair of congenital heart defects usually requires the heart to be stopped using a cold solution containing potassium (cardioplegia) which protects the heart and keeps it still when operating. Cold cardioplegia solutions may have deleterious effects on the recovery of the heart after surgery in adults. However, very little is known about the effects of using warm cardioplegia solutions in children. Therefore, children undergoing open heart surgery will be assigned by chance to one of two groups, using either warm or cold cardioplegia solutions to stop and protect the heart. Clinical and biochemical measures of recovery and complications following surgery will be compared between the two groups. A sub-study will also look at methods for measuring core body temperature monitoring in children undergoing cardiac surgery with cardiopulmonary bypass.

THERMIC-2 trial published at: http://dx.doi.org/10.1136/heartjnl-2018-313567

More Details: Intermittent antegrade warm blood versus cold blood cardioplegia in children undergoing open heart surgery (THERMIC-3) (ISRCTN13467772)

Study type: Observational
Phase: N/A
Location: Single Centre – Bristol Royal Hospital for Sick Children.
Objective: To compile a data registry of patients with CHD undergoing surgery and/or catheterisation, bringing together routinely collected clinical data, as well as collecting bio-samples (blood, urine and waste tissue when appropriate) in order to characterise patients and their biological mothers genetically and phenotypically.

More Details: Outcome monitoring after cardiac procedure in congenital heart disease (Children OMACp) (ISRCTN17650644)

Study type: Interventional
Phase: II
Location: Multi Centre (2) – Birmingham Children’s Hospital, Leeds Children’s Hospital.
Objective: To determine whether adequately delivered remote ischaemic preconditioning (RIPC) improves myocardial protection and reduces markers of IR injury in young children undergoing surgery, and whether any effects are attenuated in those with chronic hypoxaemia. To determine whether RIPC has an impact on myocardial metabolism at the onset and end of surgical ischaemia, and whether this is impact by preoperative chronic hypoxaemia.

More Details: The Bilateral Remote Ischaemic Conditioning in Children (BRICC) trial (ISRCTN12923441)

Study type: Observational
Phase: N/A
Location: Single Centre – Bristol Royal Hospital for Sick Children.
Objectives:

1. To describe the prevalence of the different types of blood clotting abnormality in children before and after cardiac surgery.
2. To estimate the association between (a) the laboratory test results and clinical concern about bleeding (CCB) after cardiac surgery, and (b) different types of blood clotting abnormality and clinical concern about bleeding after cardiac surgery.
3. To estimate the diagnostic accuracy of ROTEM tests vs. reference laboratory tests for the different types of blood clotting abnormality identified (a) before and (b) after cardiac surgery.
4. To investigate the agreement between the treatment recommended by the results of the reference tests and the treatment recommended by the ROTEM test results.

More Details: The Decision Study (ISRCTN55439761)