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ID07309848

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

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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

All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

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

Post-operative Follow-up

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

Actively Recruiting

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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