Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Early Surgical Fixation Prospective cohort of patients with intertrochanteric fractures with DOAC (direct oral anticoagulation) therapy undergoing early surgical fixation (within 24 hours). |
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.
|
| Delayed Surgical Fixation Retrospective control group of patients with intertrochanteric fractures with DOAC medication who underwent delayed surgical fixation (≥48 hours) from January 2014 to December 2018. |
Outcome Measures
Primary Outcome Measures
- Evaluation of the perioperative blood loss [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".
- Evaluation of the perioperative need for transfusions [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 Outcome Measures
- Coagulation parameters [3 days]
Coagulation parameters such as plasma DOAC concentrations and Clot Pro analyzes will be measured in accordance with routine clinical practice.
Eligibility Criteria
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
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical University of Vienna, Department of Traumatology | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1636/2021