Delivery and Implementation of a Randomised Crossover Trial on Thrombosis (DIRECT)

Background

People who break their hip (hip fracture) are at high risk of developing blood clots in their veins, known as venous thromboembolism (VTE). These clots can lead to serious complications such as deep vein thrombosis (DVT) or pulmonary embolism (PE), which can be life-threatening.

Currently, many hospitals use injections of a medicine called Low Molecular Weight Heparin (LMWH) to prevent these blood clots. However, some hospitals already use aspirin, which is a tablet taken by mouth. Aspirin is much cheaper and easier to take, but it’s still unclear whether it works as well and is as safe as LMWH for people recovering from hip fractures.

This trial aims to answer that question once and for all. If aspirin is shown to be just as effective and safe, it could save the NHS money and make treatment more comfortable for patients.

Hospitals are invited to complete our Site Feasibility Questionnaire to take part in the DIRECT Trial.

Summary

The DIRECT trial will evaluate a change in policy in blood clot prevention following a hip fracture:

  • Aspirin tablets (taken by mouth once a day for 28 days)
  • LMWH injections (given under the skin once a day for 28 days)

96 hospitals across England and Wales will take part. Each hospital will follow one of these treatments for a few months, then switch to the other. The results will be compared using existing NHS data about hospital treatment and recovery.

Because both medicines are already used in standard care, patients will automatically receive the treatment chosen for their hospital during that period – no extra visits or procedures are needed.

Aims & Objectives

Main aim:

  • To find out whether aspirin works as well and is as safe as LMWH for preventing blood clots after a hip fracture.

Secondary objectives:

  • Measure differences in deaths caused by blood clots between the two treatments.
  • Measure differences in deaths caused by bleeding or heart problems between the two treatments.
  • Compare hospital stays, readmissions, and other healthcare costs between the two treatments.
  • Assess long-term health and quality of life (in “quality-adjusted life years”) and evaluate which option gives better value for the NHS.

 

Study Design

The trial involves 96 NHS hospitals across England and Wales. It will include over 21,000 adults aged 60 years or older who are admitted with a hip fracture. Each hospital will use one treatment (aspirin or LMWH) for five months, then switch to the other for another five months.

All patient data will come from existing national records, such as the National Hip Fracture Database and hospital records. The trial will not require extra clinic visits or direct consent because both treatments are already part of standard NHS care.

 

Possible Outcomes and Benefits

If aspirin is shown to be just as safe and effective as LMWH:

  • Patients could take an oral medicine instead of having daily injections.
  • The NHS could save around £27 million per year in treatment costs.
  • Hospitals could simplify care and improve patient comfort.
  • Results would help update NICE guidelines and standardise care across the UK.

Hospitals interested in taking part in the DIRECT Trial can complete the Site Feasibility Questionnaire
(https://forms.cloud.microsoft/e/ersu2XyFP1)

 

funded by

NIHR Health Technology Assessment Programme

sponsor

Queen Mary Univeristy of London

Our Team

Chief Investigator

Professor Xavier Griffin

Trial Manager

Dr. Nkemjika Abiakam

Contact us

Have a question or want to get involved?

DIRECT Trial management team

direct-bjh@qmul.ac.uk