Delivery and Implementation of a Randomised Crossover Trial on Thrombosis

NCT06937372 | Not Yet Recruiting

• 2 other identifiers: Edge Number: 177790NIHR159321
• Study Type: interventional
• Target: 21,194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Fractures; Venous Thromboembolism (VTE)

Keywords

Hip fracture; Blood clot; Aspirin; Low molecular weight heparin (LMWH)

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days (safety) and 90 days (efficacy)

Secondary Outcomes (2)

• Cause-Specific Mortality

  90 days

• Major Bleeding Events

  28 days

Study Arms (2)

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.

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.

Drug: Low molecular weight heparin (LMWH)

Interventions

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.

Aspirin Arm

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.

Low Molecular Weight Heparin (LMWH) Arm

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead

MeSH Terms

Conditions

Hip Fractures; Venous Thromboembolism; Thrombosis

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Central Study Contacts

Nkemjika S Abiakam, BSc, MRes, MSc, PhD

CONTACT

00000000; n.abiakam@qmul.ac.uk

Jamila Kassam, BSc (Hons), MRes MCSP

CONTACT

j.kassam@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 22, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01