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

Medical University of Vienna

Status: Enrolling

Conditions: Hip Fractures

Treatments: Procedure: Early Surgical Fixation vs. Delayed Surgical Fixation

Study type: Observational

Funder types: Other

Identifiers

NCT05070169

1636/2021

Details and patient eligibility

About

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).

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

140 participants in 2 patient groups

Early Surgical Fixation

Description:

Prospective cohort of patients with intertrochanteric fractures with DOAC (direct oral anticoagulation) therapy undergoing early surgical fixation (within 24 hours).

Treatment:

Procedure: Early Surgical Fixation vs. Delayed Surgical Fixation

Delayed Surgical Fixation

Description:

Retrospective control group of patients with intertrochanteric fractures with DOAC medication who underwent delayed surgical fixation (≥48 hours) from January 2014 to December 2018.