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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05070169
Other study ID # 1636/2021
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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)

Study Design


Related Conditions & MeSH terms


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
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