Clinical trial NCT06937372: Delivery and Implementation of a Randomised Crossover Trial on Thrombosis
Official title: Delivery and Implementation of a Randomised Cluster Crossover Trial on Thrombosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hip Fractures
Venous Thromboembolism (VTE)
Keywords: Hip fracture
Blood clot
Aspirin
Low molecular weight heparin (LMWH)
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 21194
Sex: ALL
Minimum age (years): 60
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A multicentre, pragmatic, standard-of-care controlled, cluster (hospital) randomised, single crossover, registry-enabled trial reporting a single-sided comparison for non-inferiority of a first-line thromboprophylaxis strategy including aspirin compared with LMWH.
Primary purpose: TREATMENT

Brief summary: What is the Study About? The DIRECT study (Delivery and Implementation of a Randomised Crossover Trial on Thrombosis) is a large research project investigating the best way to prevent blood clots (thrombosis) in people who break their hip. The study will compare two common treatments: aspirin (a tablet) and low molecular weight heparin (LMWH, an injection).

Every year, thousands of people in the UK suffer a hip fracture, which often requires surgery and hospital care. After a hip fracture, patients are at risk of developing serious blood clots in their legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE), which can be life-threatening. Currently, doctors prescribe different medications to prevent these clots, but there is uncertainty about which treatment is best for people with hip fractures.

Why is This Study Needed? Blood clot prevention is vital for hip fracture patients, but the current recommended treatment (LMWH) involves daily injections for 28 days, which some patients find uncomfortable and difficult to manage at home. Aspirin, a tablet taken by mouth, is a much simpler alternative, but there is not enough evidence to confirm whether it is as effective and safe as LMWH in this group of patients.

The DIRECT study will help doctors and the NHS understand whether aspirin could be a safe and cost-effective alternative to LMWH. If aspirin is found to be just as effective, it could make treatment easier for patients and save millions of pounds for the NHS.

How Will the Study Work? The study will involve 96 hospitals across the UK and will include over 21,000 patients aged 60 and older who have broken their hip. Hospitals will be randomly assigned to use either aspirin or LMWH as their standard treatment for a set period. After this, they will switch to the other treatment. This approach allows researchers to compare the two treatments fairly.

All data will be collected from national NHS databases, which routinely record patient care and outcomes. This means patients will not need to do anything extra or attend additional follow-ups.

What Are the Expected Benefits?

This study will provide clear evidence on which treatment is better for preventing blood clots while minimising risks like bleeding. If aspirin is shown to be as effective as LMWH, it could:

* Reduce the need for daily injections, making treatment more comfortable for patients.
* Lower NHS costs, as aspirin is much cheaper than LMWH.
* Provide a simple, widely available treatment option for older adults with hip fractures.

How Will Patient Data Be Protected? The study will use anonymised patient data from NHS records. This means that all personal details will be kept confidential and protected according to strict NHS and research regulations. Patients who do not want their data to be used can opt out via NHS data-sharing policies.

Summary The DIRECT study is an important project that will help improve care for hip fracture patients by determining whether aspirin can be a safe and effective alternative to injections for preventing blood clots. The results will help shape future NHS guidelines, ensuring patients receive the best possible treatment while reducing unnecessary costs and discomfort.


Eligibility criteria: Inclusion Criteria:

* Adults from 60 to 150 years sustaining fragility hip fracture identified by their entry into UK hip registries.

Exclusion Criteria:

* Individuals who do not meet the eligibility criteria to be enrolled in the NHFD and SHFA registries Hip fracture individuals above 150 years of age.

Primary outcomes:
measure: Primary Composite Outcome: 90-Day Symptomatic Venous Thromboembolism (VTE) and All-Cause Mortality
timeFrame: 28 days (safety) and 90 days (efficacy)
Secondary outcomes:
measure: Cause-Specific Mortality
timeFrame: 90 days
measure: Major Bleeding Events
timeFrame: 28 days
Other outcomes:
Locations:
Study officials:
References: