DIRECT
Research type
Research Study
Full title
The DIRECT Study: a highly pragmatic, efficient, whole population randomised trial of thromboprophylaxis in hip fracture.
IRAS ID
271289
Contact name
Xavier L Griffin
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Research Summary:
In the UK there are 70,000 hip fractures annually. One common complication after hip fracture treatment is a blood clot, known as hospital-associated venous thromboembolism (VTE), affecting two in every five patients. The best treatments to reduce blood clots, and the complications associated with them are uncertain. In people with hip fractures the main aim of these treatments is to reduce mortality. NICE has issued a recommendation to address this specific research question. Current trials are too small to measure differences in mortality and have used proxy outcomes.\n\nThis will be a highly pragmatic, cluster randomised trial, comparing two established thromboprophyalxis first-line policies for the prevention of blood clots in people with hip fracture; using national registries to identify patients and routinely collected data to measure outcomes. Such an approach will allow us to conduct the trial at a scale necessary to detect differences in mortality. \n\nBoth thromboprophylaxis policies are already in use in UK hospitals and are commonly used in the treatment of patients with hip fracture or receiving hip replacements. A minimum of 120 hospitals will be recruited, which taken together can be expected to treat 43,800 participants with hip fracture over one year in the UK. The primary outcome will be determined at 90 days from hospital-associated VTE and bleeding events are defined within the NHS over this period following index admission to hospital.\n\nThis study will draw on data that has been routinely collected by different systems. Firstly, the National Hip Fracture Database (NHFD) and Scottish Hip Fracture Audit (SHFA) collect data related to the care of people who break a hip bone across the UK. Information held in the relevant registers of deaths in each country will be linked to treatment information held in hospital administrative databases for participants identified in the hip fracture audits to measure outcomes.Summary of Results:
Study did not open due to inadequate funding being gained.REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0002
Date of REC Opinion
20 Jan 2020
REC opinion
Favourable Opinion