Hip FracturesDIRECTNCT06937372
Delivery and Implementation of a Randomised Crossover Trial on Thrombosis
A study testing Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery. and Low molecular weight heparin (LMWH) in people with Hip Fractures and Venous Thromboembolism (VTE), run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 120 years
- Conditions the study is for
- Hip Fractures, Venous Thromboembolism (VTE)
- What is being tested?
- Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery. and Low molecular weight heparin (LMWH)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21,194 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults from 60 to 150 years sustaining fragility hip fracture identified by their entry into UK hip registries.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jamila Kassam, BSc (Hons), MRes MCSP contact
United Kingdom1 site, 1 recruiting
- Recruiting
Whipps Cross University Hospital
London, E11 1NR
Jonathan Ward
About this study
Official title: Delivery and Implementation of a Randomised Cluster Crossover Trial on Thrombosis
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.
Read more
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.
- Conditions
- Hip Fractures, Venous Thromboembolism (VTE)
- Being tested
- Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery., Low molecular weight heparin (LMWH)
- Keywords
- Hip fracture, Blood clot, Aspirin, Low molecular weight heparin (LMWH)
- Medical subject headings
- Hip Fractures, Venous Thromboembolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery.Drug
Unlike low molecular weight heparin (LMWH), which requires daily subcutaneous injections, aspirin is taken orally, making it more comfortable and acceptable for patients, particularly the elderly or those with mobility issues. Aspirin is significantly less expensive than injectable anticoagulants like LMWH or newer oral anticoagulants, making it a potentially cost-effective alternative for thromboprophylaxis.
Low molecular weight heparin (LMWH)Drug
LMWH is administered via daily subcutaneous injection, typically starting shortly after surgery and continued for a defined period as per each hospital's local policy, often 14 to 28 days. LMWH has a proven track record of reducing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) after surgery.
However, it carries a risk of bleeding and may be challenging for some frail or elderly patients to tolerate, especially if self-injection is required post-discharge.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Arm | Experimental | Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery. Aspirin is a widely available, low-cost medication that may reduce the risk of blood clots with fewer side effects such as bleeding. Receives: Drug: Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery. |
| Low Molecular Weight Heparin (LMWH) Arm | Active comparator | Patients in hospitals allocated to this arm will receive LMWH, which is the current standard treatment in many hospitals for preventing blood clots after hip surgery. Receives: Drug: Low molecular weight heparin (LMWH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Composite Outcome: 90-Day Symptomatic Venous Thromboembolism (VTE) and All-Cause Mortality
To estimate and draw inferences on the risk differences between first-line venous thromboembolism (VTE) thromboprophylaxis management strategies including aspirin versus low molecular weight heparin (LMWH) of the co-primary outcomes of VTE events, combined pulmonary embolism (PE) and deep vein thrombosis (DVT), within 90 days (efficacy) and major bleeding events within 28 days (safety) after hospital admission following index hip fracture.
Measured: 28 days (safety) and 90 days (efficacy)
Secondary outcomes (2)
Cause-Specific Mortality
Deaths specifically attributable to pulmonary embolism, bleeding, or other identifiable causes within 90 days post-surgery
Measured: 90 days
Major Bleeding Events
Incidents of clinically significant bleeding requiring medical intervention or transfusion.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jul 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 21,194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937372
- Sponsor's protocol ID
- Edge Number: 177790
- Other IDs
- NIHR159321
- Acronym
- DIRECT
- Status last verified
- Sep 2026
- First submitted
- 10 Apr 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery and Implementation of a Randomised Cluster Crossover Trial on Thrombosis
- ClinicalTrials.gov ID
- NCT06937372
- Acronym / sponsor ID
- DIRECT / Edge Number: 177790
- Conditions
- Hip Fractures, Venous Thromboembolism (VTE)
- Keywords
- Hip fracture, Blood clot, Aspirin, Low molecular weight heparin (LMWH)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 21,194 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Aspirin Arm | Experimental | Drug: Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery.Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery. Aspirin is a widely available, low-cost medication that may reduce the risk of blood clots with fewer side effects such as bleeding. |
| Low Molecular Weight Heparin (LMWH) Arm | Active comparator | Drug: Low molecular weight heparin (LMWH)Patients in hospitals allocated to this arm will receive LMWH, which is the current standard treatment in many hospitals for preventing blood clots after hip surgery. |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults from 60 to 150 years sustaining fragility hip fracture identified by their entry into UK hip registries.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery.Unlike low molecular weight heparin (LMWH), which requires daily subcutaneous injections, aspirin is taken orally, making it more comfortable and acceptable for patients, particularly the elderly or those with mobility issues. Aspirin is significantly less expensive than injectable anticoagulants like LMWH or newer oral anticoagulants, making it a potentially cost-effective alternative for thromboprophylaxis. | Drug | Aspirin Arm |
| Low molecular weight heparin (LMWH)LMWH is administered via daily subcutaneous injection, typically starting shortly after surgery and continued for a defined period as per each hospital's local policy, often 14 to 28 days. LMWH has a proven track record of reducing the risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) after surgery. However, it carries a risk of bleeding and may be challenging for some frail or elderly patients to tolerate, especially if self-injection is required post-discharge. | Drug | Low Molecular Weight Heparin (LMWH) Arm |
Primary outcome
Primary Composite Outcome: 90-Day Symptomatic Venous Thromboembolism (VTE) and All-Cause Mortality
Time frame: 28 days (safety) and 90 days (efficacy)
To estimate and draw inferences on the risk differences between first-line venous thromboembolism (VTE) thromboprophylaxis management strategies including aspirin versus low molecular weight heparin (LMWH) of the co-primary outcomes of VTE events, combined pulmonary embolism (PE) and deep vein thrombosis (DVT), within 90 days (efficacy) and major bleeding events within 28 days (safety) after hospital admission following index hip fracture.
2 secondary outcomes
Cause-Specific Mortality
Time frame: 90 days
Major Bleeding Events
Time frame: 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamila Kassam, BSc (Hons), MRes MCSP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients in hospitals allocated to this arm will receive aspirin as their routine thromboprophylaxis after surgery. and Low molecular weight heparin (LMWH) in people with Hip Fractures and Venous Thromboembolism (VTE), run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nkemjika S Abiakam, BSc, MRes, MSc, PhD (00000000, n.abiakam@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Composite Outcome: 90-Day Symptomatic Venous Thromboembolism (VTE) and All-Cause Mortality (time frame: 28 days (safety) and 90 days (efficacy)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.