Utilization of Thromboelastography to Monitor Rivaroxaban Activity in Trauma and Emergency Surgery Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in thromboelastography (TEG) as a measure of anticoagulation following Rivaroxaban reversal in trauma and emergency general surgery patients
研究概览
简要总结
The invesigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patients available as point-of-care testing.
Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.
详细描述
Rivaroxaban is a novel factor Xa inhibitor that is widely used for stroke prevention in nonvalvular atrial fibrillation, treatment of venous thromboembolism (VTE), and for VTE prophylaxis in patients undergoing knee or hip replacement surgery.
Current standard measurements of coagulation are relatively poor at reliably measuring detecting Rivaroxaban effects and more elaborate means of testing such as measurement of factor Xa activity are not immediately available so not useful in Urgent situations such as traumatic injury or emergent surgical indications. Due to the unmet need to devise a strategy for detecting Rivaroxaban activity in urgent situations, unnecessary reversal, which can lead to significant complications and cost, often results.
The investigators seek to devise a strategy for the assessment of Rivaroxaban activity in trauma and Emergency General Surgery (EGS) patient available as point-of-care testing.
Thromboelastography (TEG) is a point of care, viscoelastic measurement of coagulation that is widely used in trauma and is viewed by many as superior to standard coagulation studies for the assessment of coagulopathy following injury and may be useful in detecting Rivaroxaban effect in trauma and EGS patients to assess the degree of functional factor Xa impairment.
This proposed study is a observational, prospective, cross sectional, study evaluating the Pharmacokinetics of rivaroxaban utilization thromboelastography (TEG) in a population of 80 trauma and emergency EGS patients who were taking rivaroxaban prior to admission and 20 active control trauma and EGS patients who were not taking rivaroxaban prior to admission (matched by age gender injury mechanism or illness)
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
- •Age ≥ 18 years
- •Evidence of Rivaroxaban use with-in the last 48hours per medical records or report by patient, family, or other healthcare member familiar with patients drug medical history
- •Willingness of subject or legally authorized representative to provide written consent for study procedures.
排除标准
- •Known to be pregnant
- •Known to be a prisoner
- •Known Chronic liver disease
- •Documented hypo coagulation condition (hemophilia, Von Willebrands, any congenital factor deficiency (V,X,XII) leukemia)
- •Use of any anticoagulant medication other than Rivaroxaban (examples: Warfarin, lovenox, arixtra, fragmin, eliquis)
- •Prehospital blood product administration (FFP, platelets, Prothrombin Complex Concentrate (PCC), tranexamic acid (TXA)
- •Non-survivable traumatic brain Injury
- •Comfort Measure Only (CMO) status
结局指标
主要结局
Change in thromboelastography (TEG) as a measure of anticoagulation following Rivaroxaban reversal in trauma and emergency general surgery patients
时间窗: 2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal
To best observe inhibition of factor Xa, the investigators will perform kaolin TEGs as opposed to alternative forms of activated TEG (rapid-TEG) which may artificially induce coagulation and miss an effect on factor Xa activity. Additional TEG formats that may better target factor Xa inhibition will be investigated in parallel. As a control group, a second cohort of trauma and EGS patients (matched by demographics, injury mechanism, and illness) who are not taking Rivaroxaban will be identified. TEG and coagulation studies will be obtained on admission as described above. Following reversal of Rivaroxaban for subjects that a clinical decision is made to give reversal agents, or at 24 hours post admission for all other subjects, the TEG and PT/PTT/INR will be repeated to assess for changes in both groups.
次要结局
- TEG as a point-of-care analysis following Rivaroxaban as compared to the standard of care measurement of coagulation.(2 time-points: First TEG immediately upon presentation to the emergency department - 2nd timepoint is within 1 hour of Rivaroxaban reversal)
研究者
Matthew Neal MD
Matthew D. Neal, MD
University of Pittsburgh