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RecruitingNAINTERVENTIONAL

Delivery and Implementation of a Randomised Crossover Trial on Thrombosis

The DIRECT study is a big research project looking into the best way to stop blood clots forming in people who have broken their hip. After a hip fracture, patients are at risk of serious clots in their legs or lungs. Currently, various medicines are used, but we don't know which is best for this specific group. This study compares two common treatments: aspirin (a tablet) and low molecular weight heparin (LMWH, a daily injection). The main goal is to see if aspirin, which is simpler and cheaper, is just as safe and effective as LMWH. If it is, this could make treatment much easier for patients and save the NHS a lot of money, shaping future care guidelines.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Queen Mary University of London
Enrolment target
21,194
Start
01 Jul 2026
Estimated completion
30 Apr 2028

What is this study about?

When someone breaks their hip, which often needs surgery and hospital care, there's a risk of serious blood clots forming. These clots can appear in the legs (called a deep vein thrombosis or DVT) or travel to the lungs (called a pulmonary embolism or PE), which can be very dangerous. To stop these clots, doctors currently use different medicines, but it's not fully clear which one works best and is easiest for people with hip fractures.

The DIRECT study is a large research project that wants to answer this question. It's comparing two main treatments: aspirin, which is a tablet you take by mouth, and low molecular weight heparin (LMWH), which is given as a daily injection. We know preventing these clots is crucial, but daily injections for a month can be uncomfortable and tricky for some people to manage, especially at home. Aspirin is much simpler, but we need more proof that it's just as good and safe as injections for hip fracture patients.

This study will involve many hospitals across the UK and over 21,000 patients. It will help doctors and the NHS understand if aspirin could be a safe, effective, and more convenient option. If aspirin is found to work just as well, it could make treatment much easier for patients, potentially saving money for the NHS, and improve care for thousands of people every year.

Key takeaways

  • The DIRECT study compares aspirin vs. injections to prevent blood clots after a hip fracture.
  • It aims to find a safer, easier, and potentially cheaper treatment option.
  • No extra appointments or actions are needed from patients.
  • Your personal data is protected and anonymised.
  • The results could change future NHS guidelines for hip fracture care.

Who may be eligible?

This study is for adults who have recently broken their hip. To be included, you generally need to be 60 years old or older.

The study focuses on patients whose hip fracture is recorded in national UK health registries. This helps make sure that the information gathered is consistent and accurate.

It's important to note that if your hip fracture isn't recorded in these specific registries, or if you are under 60, you wouldn't be part of this particular study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 60 years old or older?
  2. Have you recently broken your hip?
  3. Is your hip fracture recorded in a UK hip registry?
  4. Are you receiving care in a UK hospital participating in this study?
Answer every question to see your result.

What does participation involve?

This study is designed to use information already collected by the NHS. This means that if you are part of this study, you won't need to do anything extra. There are no additional appointments, tests, or visits beyond your usual care. You also won't be asked to take any study-specific medication.

Instead, the hospital you are treated in will be following a specific plan for preventing blood clots using either aspirin or LMWH, which is part of their standard practice for a set period. Researchers will then look at your routine health records (which are kept private) to understand how well these standard treatments worked for many patients. The study simply collects information about the care you would already be receiving, so it won't impact your daily life or treatment.

Potential risks and benefits

The main benefit of this study is that it will provide clear evidence to help doctors choose the best and safest way to prevent blood clots after a hip fracture. If aspirin proves to be as effective, it could lead to easier, more comfortable treatment for patients (no daily injections) and save the NHS money. Because the study only uses information from routine NHS records, there are no extra risks or changes to your care directly from being part of the study. All your personal details will be kept confidential and protected. You always have the right to decide that your anonymised data should not be used in research, and you can opt out through NHS data-sharing policies.

Locations (1)

  • Whipps Cross University Hospital
    Verified postcode
    London, United Kingdom· Recruiting

Common questions

What is the DIRECT study about?

It's a large UK study comparing two ways to prevent blood clots in people who've broken their hip: aspirin tablets versus daily injections (LMWH).

Why is this study important for me?

If you've had a hip fracture, this study aims to find the safest and easiest way to prevent dangerous blood clots, potentially making your recovery simpler.

Do I need to do anything extra if I'm in this study?

No, you don't need to do anything extra. The study uses information already collected by the NHS from your regular care.

How will my personal information be kept private?

The study uses anonymised data from NHS records, meaning your personal details are removed and kept private, following strict regulations.

Can I choose not to have my data used?

Yes, you can opt out of having your health data used for research by following the NHS data-sharing policies.

How to find out more

Nkemjika S Abiakam, BSc, MRes, MSc, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Delivery and Implementation of a Randomised Crossover Trial …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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