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NCT Number: NCT05070169

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

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).

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Key information

Conditions

Hip Fractures Femoral Fractures Fractures, Bone Hip Injuries Leg Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna, Department of Traumatology

Vienna, 1090, Austria

Location status: Recruiting

Location contact

Valerie Weihs, MD

CONTACT

[email protected]

00436505008952

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Early Surgical Fixation vs. Delayed Surgical Fixation

Procedure

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 outcomes

  1. Evaluation of the perioperative blood loss

    Time frame: 3 days

    The main objective of this study is the evaluation of the perioperative blood loss in patients with intertrochanteric fractures with DOAC medication treated in a level I trauma center undergoing early surgical fixation (within 24 hours after the trauma). After routine surgical fixation of the fracture, patients will receive blood draws at day 3 according to standardized routinely performed clinical procedures. The perioperative blood loss will be calculated using the "haemoglobin balance method".

  2. Evaluation of the perioperative need for transfusions

    Time frame: 3 days

    The rate of transfusion will be expressed as the percentage of patients who need at least one unit of red blood cells (RBCs) and the total number of transfused RBC units will be recorded. Only perioperative transfusion up to the third post-operative day will be considered.

Secondary outcomes

  1. Coagulation parameters

    Time frame: 3 days

    Coagulation parameters such as plasma DOAC concentrations and Clot Pro analyzes will be measured in accordance with routine clinical practice.

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2021
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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