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

Hip Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05070169
• Other study ID #: 1636/2021
• Status: Recruiting
• Start date: October 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 31, 2024
• Est. primary completion date: September 15, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Traumatology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the perioperative blood loss	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".	3 days
Primary	Evaluation of the perioperative need for transfusions	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.	3 days
Secondary	Coagulation parameters	Coagulation parameters such as plasma DOAC concentrations and Clot Pro analyzes will be measured in accordance with routine clinical practice.	3 days