NCT05070169 Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
| NCT ID | NCT05070169 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Vienna |
| Condition | Hip Fractures |
| Study Type | OBSERVATIONAL |
| Enrollment | 140 participants |
| Start Date | 2021-10-15 |
| Primary Completion | 2025-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 140 participants in total. It began in 2021-10-15 with a primary completion date of 2025-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Prospective cohort study on patients with intertrochanteric fractures under direct oral anticoagulation (DOAC) therapy undergoing early surgical fixation (within 24 hours). The primary aim of this study is to evaluate the reduction of the peri operative blood loss. The secondary aim is to assess the influence of early surgical fixation of intertrochanteric fractures in patients with DOAC therapy on the 30-day and 1-year mortality. Moreover, the prospective cohort group of patients will be compared with a retrospectively analyzed age-, gender- and fracture-type-matched control group of patients who underwent delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours).
Eligibility Criteria
Inclusion Criteria: Prospective cohort study: Patients with intertrochanteric fractures that need a surgical fixation and under treatment with a DOAC medication Control group: Patients with intertrochanteric fractures under DOAC medication with a delayed surgical fixation from January 2014 to December 2018 (≥ 48 hours after the trauma) Exclusion Criteria: Prospective cohort group: * patients with multiple fractures * acute heart failure, kidney and lung failure and * other concomitant diseases which prevent prompt fixation Retrospective cohort group: Patients with delayed surgical fixation due to other causes than DOAC medication (e.g. multimorbidity, acute myocardial infarction, acute heart, lung or kidney failure)
Frequently Asked Questions
Who can join the NCT05070169 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05070169 currently recruiting?
Yes, NCT05070169 is actively recruiting participants. Visit ClinicalTrials.gov or contact Medical University of Vienna to inquire about joining.
Where is the NCT05070169 trial being conducted?
This trial is being conducted at Vienna, Austria.
Who is sponsoring the NCT05070169 clinical trial?
NCT05070169 is sponsored by Medical University of Vienna. The trial plans to enroll 140 participants.