H. pylori Eradication vs Aspirin Toxicity (HEAT) Trial: Pilot Study
Lead Research Organisation:
University of Nottingham
Department Name: Nottingham Digestive Diseases Centre
Abstract
The protocol has been drawn up with the help of the primary care research users group in Nottingham. Representatives will sit on the project advisory board, help with all patient information and communication documents, provide advice on how best to contact applicants and advice on the use of the media for recruitment and publicity. They have been centrally involved in the development of our research plans. The study will depend upon high level media publicity for success and this group will help us with this aspect of the subject and with using the links that are consequently developed to publicise results of the research when the trial is complete.
Technical Summary
The proposed trial
Substantive trial: Consenting aspirin users 60, identified by MIQUEST automated searching will undergo H. pylori breath testing and randomisation, if positive, to eradication immediately or after 18 months delay. Rates of ulcer bleeding over the first and second 18 month period will be assessed using primary (MIQUEST) and secondary care records and NHS Central Registry (deaths). Outcomes, confirmed by an adjudication committee, will be compared for the two randomised groups and for non-randomised H. pylori negative participants.
Pilot Study: Rates of aspirin use and ulcer bleeding in potential collaborating areas will be established using the QResearch Database. Direct study in these areas will also investigate aspirin use as well as H. pylori infection in aspirin users, the success of eradication treatment and evaluate the feasibility of study methods.
Substantive trial: Consenting aspirin users 60, identified by MIQUEST automated searching will undergo H. pylori breath testing and randomisation, if positive, to eradication immediately or after 18 months delay. Rates of ulcer bleeding over the first and second 18 month period will be assessed using primary (MIQUEST) and secondary care records and NHS Central Registry (deaths). Outcomes, confirmed by an adjudication committee, will be compared for the two randomised groups and for non-randomised H. pylori negative participants.
Pilot Study: Rates of aspirin use and ulcer bleeding in potential collaborating areas will be established using the QResearch Database. Direct study in these areas will also investigate aspirin use as well as H. pylori infection in aspirin users, the success of eradication treatment and evaluate the feasibility of study methods.