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Recruiting NCT05070169

Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation

— Observational Hip Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early Surgical Fixation vs. Delayed Surgical Fixation.
Who it may be relevant to
Registry conditions: Hip Fractures. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Procedure Early Surgical Fixation vs. Delayed Surgical Fixation
    Evaluation of the reduction of the peri-operative blood loss in patients undergoing early surgical fixation (within 24 hours) of an intertrochanteric fracture under DOAC therapy compared to a retrospectively enrolled group of patients who underwent delayed surgical fixation (≥48 hours) of an intertrochanteric fracture under DOAC therapy.

Primary outcome measures

  • Evaluation of the perioperative blood loss [Time frame: 3 days]
  • Evaluation of the perioperative need for transfusions [Time frame: 3 days]
Secondary outcome measures (1)
  • Coagulation parameters [Time frame: 3 days]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medical University of Vienna, Department of Traumatology — Vienna

Identifiers

NCT: NCT05070169 · 1636/2021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗