1510160 / The REAppropriate study

The REAppropriate study: Perception of inappropriate CPR: A multicentre international cross-sectional survey (Study due to close 17/05/2015)

1612339 / RAMPP

Pneumothorax – air in the pleural space – is common (~3,000 patients per year in the UK). Primary spontaneous pneumothorax (PSP) is said to occur, in the absence of trauma, in patients with no underlying established lung disease. Some patients are managed conservatively with close observation only; however, many patients will require an intervention to re-inflate the lung. In some cases aspiration of air using cannula and syringe will be sufficient, but many will need to have a chest drain inserted with standard underwater seal with the average duration of in-patient stay of 6-8 days. Portable/’ambulatory’ devices (such as Rocket Pleural Vent) provide the option to treat these patients as an outpatient while their lung reinflates.

RAMPP is an interventional multi-centre (UK only) randomised controlled trial comparing ambulatory to standard (in-patient treatment with aspiration/chest drain) management of primary pneumothorax. Primary outcome is total hospital stay up to 30 days post-randomisation. The study will also investigate whether digitally measured air leak can predict short term outcome (prolonged air leak and requirement for surgery) and whether radiological evidence (on CT scanning) of emphysema-like change and inflammation can predict long term outcome (recurrence rates at 12 months).

Patients will have baseline observations and blood tests and then will be reviewed daily either on the ward (standard management group) or as an outpatient (ambulatory group) with chest x-ray, air leak measurement and assessment of breathlessness and chest discomfort. Patients who do not require treatment, after their initial assessment, can be discharged but return for follow up. All patients will be followed-up at 1 week post treatment completion (including a CT scan), and then at 1, 6 & 12 months post enrolment.

The study is funded by the NIHR Research for Patient Benefit Programme and an MRC Fellowship grant. (Study due to close 31/03/2020)

1705418 / A randomised controlled trial of topical intranasal tranexamic acid versus placebo to reduce the need for nasal packing in patients presenting to the Emergency Department with spontaneous epistaxis.

Can tranexamic acid (TXA) reduce the need for nasal packing in adult patients presenting to the Emergency Department (ED) with spontaneous, serious, nosebleed?
Nosebleed is a very common condition. In most cases nosebleeds stop with simple first aid measures, but some cases are more serious, leading to hospital admission or even death. Patients with serious nosebleed attending the ED are initially treated with vasoconstrictors (solution applied to the inside of the nostril) or cauterisation (briefly burning the blood vessel to seal it).

If bleeding cannot be stopped with these measures, patients usually undergo nasal packing. Nasal packing involves stuffing the nasal passage tightly with a dressing to apply pressure to the source of the bleeding, an extremely uncomfortable and painful experience. The nasal pack is left in place for about 48 hours and patients are admitted to hospital for monitoring during this time.

In other conditions where bleeding is a problem, TXA (injection and tablet) has been shown to help the normal blood clotting process, making clots less likely to break down. TXA has the potential to safely stop serious nosebleeds, and hence reduce the need for patients to undergo nasal packing and an in-patient hospital stay.

This study is a double blind randomised controlled trial. Patients with a serious nosebleed that fails to stop after first aid and initial treatment in the ED are eligible to participate. In the ED, consented participants will receive either TXA or water (placebo) soaked into a small cotton wool roll and placed inside the bleeding nostril for a short time. After trial treatment, participants will resume the usual local care pathway. One week after the ED visit, the research nurse will telephone participants to collect information on any adverse reactions/complications relating to the study, and any further episodes of nosebleeds since the ED visit. (Study due to close 30/09/2018)

1802574 / A randomised, double-blind, multicentre, placebo controlled study to evaluate the safety and efficacy of methoxyflurane (PENTHROX®) for the treatment of acute pain in children and adolescents from 6 to less than 18 years of age (presenting to an Emergency Department with minor trauma)

About 220 people will take part in this study (176 children of 6–11 years of age, and 44 adolescents of 12–17 years of age). The study will be conducted at approximately 10 hospitals in the United Kingdom (UK) and Republic of Ireland. The overall purpose of the study is to gain more information on how well methoxyflurane (PENTHROX®), the study drug, works at relieving pain in patients 6–17 years of age who are admitted to a hospital emergency department with a minor injury (known as trauma) and any side effects. This is a Phase 3 study, which means the study drug has already been given to other patients in other studies. Now, researchers need to learn more about the study drug when it is used in children of various ages and with different health needs. This study is being done to learn more about how best to use the study drug for patients in the future.

Methoxyflurane (PENTHROX®), the study drug, is a licensed product in the UK. It is taken using a hand-held inhaler and is currently used in the emergency department to relieve pain in injured adults. The study drug will be compared to a placebo. A placebo looks the same as the medicine being studied but does not contain any active substance.

Participants will have an equal chance (50:50) that they will be given either the study drug or placebo. This study will include screening and enrolment, followed by treatment and day 14 ± 2 day safety telephone follow-up post treatment. The procedure for screening and enrolment including obtaining consent/assent is to occur on the (Study due to close 31/07/2018)

1812729 / Identification and characterization of the clinical toxicology of novel psychoactive substances (NPS) by laboratory analysis of biological samples from recreational drug users.

Recreational drug use has been common for many years, but a major recent change in epidemiology has been the increasing use of new recreational drugs, sometimes termed Novel Psychoactive Substances (NPS) or ‘legal highs.’ These substances are numerous and associated with significant acute toxicity including increasing hospital presentations and fatalities. The effects of chronic exposure are usually unknown.

Currently there is no systematic national UK data collection system linking analytically confirmed use of NPS with acute toxicity. This causes a delay before clinicians, public health teams, law enforcement and policy makers can define and mitigate the harms associated with specific NPS. There are typically no published data available on the pharmacology and toxicity of these substances as they emerge into recreational use, leaving healthcare professionals without evidence to guide patient management in the event of toxicity.

This research will help to address this gap by collating information about the acute toxicity of NPS in the UK via four inter-related
studies using

(1) Anonymised aggregated data collected by the National Poisons Information Service (NPIS)
(2) Anonymised aggregated data available on positive samples from participating NHS toxicology laboratories
(3) Further laboratory analysis of linked-anonymised samples collected from patients with acute severe toxicity as part of usual clinical care and sent to participating NHS laboratories, where NPS use is suspected.
(4) Collection and analysis of samples from consenting patients presenting to participating emergency departments with severe toxicity associated with suspected NPS use.

Samples will be subjected to detailed toxicology analysis using state of the art methods, informed by the latest information on the NPS being encountered by clinicians in the UK.
The research will identify trends in enquiries and positive laboratory samples relating to NPS. (Study due to close 31/03/2020)

1812735 / LoDED

When someone arrives in Accident and Emergency (A&E) with chest pain, it is often hard for doctors to tell if the pain is due to a heart attack. Most patients have to wait in hospital, having two blood tests taken a few hours apart, before a heart attack can be ruled out. Only 1 in 10 of these patients have actually had a heart attack – most have conditions like heartburn that aren’t serious. Ruling-out heart attacks faster would reassure patients earlier and reduce time spent in hospital. Around 2 million people a year in Britain come to A&E with chest pain. Finding a way for them to be discharged earlier would mean hospitals would be under less pressure.

A blood test, called high-sensitivity troponin, may be used to rule-out heart attacks using just one blood sample shortly after a patient arrives in A&E. This test measures low levels of heart muscle damage in the blood. We aim to find out whether this single test works in everyday practice.

We will ask 600 patients with chest pain, arriving at one of seven A&Es, to take part in the study. We will allocate them by chance to one of two groups. One group will be discharged after one blood test, if no heart damage is found. The other group will have two blood tests as usual. We will compare groups to see how many patients can be discharged within 4 hours. We will see if the new method saves hospital resources and if patients are reassured when discharged earlier.

Patient volunteers have helped us design this research and will ensure the study is acceptable to patients.

Study results will be available to doctors and patients to allow improvements in care. (Study due to close 04/06/2019)