Early Surgical Fixation of Low-Velocity Hip Fractures in Patients With Direct Oral Anticoagulation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Evaluation of the perioperative need for transfusions
研究概览
简要总结
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Evaluation of the perioperative need for transfusions
时间窗: 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.
Evaluation of the perioperative blood loss
时间窗: 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".
次要结局
- Coagulation parameters(3 days)
研究者
Dr. Valerie Weihs
Principal Investigator
Medical University of Vienna