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Blood Transfusion Risk After Early vs. Delayed Surgery in Hip Fracture Patients on Direct Oral Anticoagulants A Natural Experiment
Led by St. Antonius Hospital · Updated on 2025-12-30
374
Participants Needed
7
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates patients with hip fractures who are taking direct oral anticoagulants (DOACs), a type of blood thinner. The study aims to determine whether performing surgery within 24 hours of hospital admission is as safe as delaying surgery beyond 24 hours. This is important because surgery delays may reduce bleeding risks but can also increase complications, longer hospital stays, and mortality. The study is designed as a natural experiment comparing these two timing strategies across multiple hospitals in the Netherlands. The study compares outcomes between patients who receive hip fracture surgery within 24 hours of emergency department arrival (early surgery) and those who have surgery after 24 hours (delayed surgery). No additional procedures are performed beyond routine care, and the timing of surgery is based on hospital protocols. Data on blood transfusions, hemoglobin levels, complications, hospital stay, and functional recovery at three months are collected from electronic health records. Participants are monitored through information routinely recorded during hospital care, including blood transfusion needs after surgery and various postoperative complications. Data quality is ensured by standardized documentation and regular checks. The main measurement is whether patients require blood transfusions after surgery, observed until hospital discharge or up to 30 days. The total participation involves hospital stay from emergency presentation until discharge, with outcomes also assessed up to three months after surgery.
CONDITIONS
Brief Title
Hip Fracture Surgery Timing and Blood Transfusion Risk in Patients on DOACs
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Isolated hip fracture classified as AO/OTA 31A or 31B requiring surgical intervention
- Current use of direct oral anticoagulants (DOACs) with the last dose taken within 24 hours before emergency department presentation
You will not qualify if you...
- Pathologic or periprosthetic hip fractures
- Fracture sustained more than 24 hours before emergency department presentation
- Inter-hospital transfer
- Hematologic disorders such as thalassemia, sickle cell disease, aplastic anemia, myelodysplastic syndromes, or leukemia
- Use of a non-EMA-approved DOAC (e.g., betrixaban)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 30 days postoperatively
Participants undergo hip fracture surgery either within 24 hours or after 24 hours of last DOAC intake, followed by immediate post-operative care during hospitalization.
Visits occur during hospital stay until discharge
Duration - Up to 120 days postoperatively
Participants are monitored for postoperative complications, functional recovery, and mortality up to 120 days after surgery.
Follow-up assessments up to 120 days after surgery
Trial Site Locations
Total: 7 locations
1
Ziekenhuisgroep Twente Hospital
Almelo, Netherlands
Actively Recruiting
2
Onze Lieve Vrouw Gasthuis Hospital
Amsterdam, Netherlands
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3
Rijnstate Hospital
Arnhem, Netherlands
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4
Deventer Hospital
Deventer, Netherlands
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5
Martini Hospital
Groningen, Netherlands
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6
Diakonessenhuis Hospital
Utrecht, Netherlands
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7
St. Antonius Hospital
Utrecht, Netherlands
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Research Team
T
Tim Schiepers, MD
H
Henk Jan Schuijt, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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