Actively Recruiting
Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
Led by Medical University of Vienna · Updated on 2024-11-25
140
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on patients with intertrochanteric hip fractures who are treated with direct oral anticoagulation (DOAC) medication. It aims to compare early surgical fixation performed within 24 hours of injury to delayed surgical fixation done 48 hours or more after injury. The study evaluates whether early surgery reduces blood loss during the operation and examines how timing affects 30-day and 1-year mortality rates. A retrospective control group matched by age, gender, and fracture type is included for comparison. The study compares two groups: one undergoing early surgical fixation within 24 hours while on DOAC therapy, and a retrospective control group who had delayed surgery after 48 hours or more. Researchers assess perioperative blood loss and the need for blood transfusions within 3 days post-surgery. Coagulation parameters are also monitored during this period to understand the effects of timing on blood clotting and recovery. Participants will be monitored closely for three days after surgery to measure blood loss, transfusion needs, and coagulation status. The study collects data on patient outcomes including survival at 30 days and one year. This prospective cohort is compared to historical patient data to evaluate differences related to surgery timing. The study is sponsored by the Medical University of Vienna and follows patients from surgery through follow-up periods to gather comprehensive safety and outcome information.
CONDITIONS
Brief Title
Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with intertrochanteric fractures requiring surgical fixation
- Patients currently treated with direct oral anticoagulant (DOAC) medication
- Adults aged 18 years or older
- Retrospective control patients with delayed surgical fixation (48 hours or more after trauma) under DOAC therapy from January 2014 to December 2018
You will not qualify if you...
- Patients with multiple fractures
- Patients with acute heart failure
- Patients with kidney failure
- Patients with lung failure
- Patients with other diseases preventing prompt surgical fixation
- Retrospective patients who had delayed surgery due to causes other than DOAC medication, such as multimorbidity or acute myocardial infarction
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 3 days
Participants undergo surgical fixation of intertrochanteric hip fractures under direct oral anticoagulation therapy, either early (within 24 hours) or delayed (48 hours or more).
1 surgical visit and daily assessments during hospital stay
Duration - 3 days
Participants are observed for perioperative blood loss, need for transfusions, and coagulation parameters after surgery.
Daily visits or assessments for 3 days post-surgery
Trial Site Locations
Total: 1 location
1
Medical University of Vienna, Department of Traumatology
Vienna, Austria, 1090
Actively Recruiting
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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