Timing of hip fracture surgery for patients on DOAC blood thinners
Blood Transfusion Risk After Early vs. Delayed Surgery in Hip Fracture Patients on Direct Oral Anticoagulants: A Natural Experiment
This project will see if operating within 24 hours is as safe as delaying surgery for people with hip fractures who recently took DOAC blood thinners by comparing how often they need blood transfusions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 374 (estimated) |
| Sex | All |
| Sponsor | St. Antonius Hospital Academic / other |
| Locations | 7 sites (Almelo and 6 other locations) |
| Trial ID | NCT07309848 on ClinicalTrials.gov |
What this trial studies
This is a multicenter observational cohort that uses variation in hospital practice across the Netherlands as a natural experiment to compare outcomes for patients having hip fracture surgery within 24 hours versus after 24 hours. Eligible patients have isolated AO/OTA 31A or 31B hip fractures and took an EMA-approved DOAC within 24 hours before emergency department presentation. The primary outcome is postoperative blood transfusion; secondary outcomes include perioperative hemoglobin change, infections, delirium, thromboembolic events, length of stay, and mortality. Because assignment to early or delayed surgery is based on routine hospital practice rather than randomization, the analysis will adjust for confounders across centers.
Who should consider this trial
Good fit: Ideal candidates are adults with isolated AO/OTA 31A or 31B hip fractures who took an EMA-approved DOAC within 24 hours before presenting to the emergency department and who do not have pathologic/periprosthetic fractures, major hematologic disorders, or inter-hospital transfer.
Not a fit: Patients with pathologic or periprosthetic fractures, hematologic disorders, use of non-EMA-approved DOACs, fractures presenting more than 24 hours after injury, or those transferred from other hospitals are not represented and may not benefit from the findings.
Why it matters
Potential benefit: If early surgery does not increase transfusion rates, patients on DOACs could have faster operations with fewer complications and shorter hospital stays.
How similar studies have performed: Existing evidence is limited and mixed from small observational reports, so this multicenter natural-experiment approach addresses a relatively unresolved and partly novel question.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Isolated hip fracture classified as AO/OTA 31A or 31B requiring surgical intervention. * Current DOAC use with the last dose taken ≤24 hours before emergency department (ED) presentation Exclusion Criteria: * Pathologic or periprosthetic hip fractures. * Fracture sustained \>24 hours before ED presentation. * Inter-hospital transfer. * Hematologic disorders (e.g., thalassemia, sickle cell disease, aplastic anemia, myelodysplastic syndromes, leukemia). * Use of a non-EMA-approved DOAC (e.g., betrixaban).
Where this trial is running
Almelo and 6 other locations
- Ziekenhuisgroep Twente Hospital — Almelo, Netherlands (Recruiting)
- Onze Lieve Vrouw Gasthuis Hospital — Amsterdam, Netherlands (Recruiting)
- Rijnstate Hospital — Arnhem, Netherlands (Recruiting)
- Deventer Hospital — Deventer, Netherlands (Recruiting)
- Martini Hospital — Groningen, Netherlands (Recruiting)
- Diakonessenhuis Hospital — Utrecht, Netherlands (Recruiting)
- St. Antonius Hospital — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Henk Jan Schuijt, MD, PhD — Amsterdam University Medical Center
- Study coordinator: Tim Schiepers, MD
- Email: t.schiepers@antoniusziekenhuis.nl
- Phone: +31637557472
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.