Venous Thromboembolic Prophylaxis After Major Trauma: A Randomized Controlled Trial of Three Times a Day Unfractionated Heparin Versus Twice a Day Enoxaparin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Lower Extremity Deep Vein Thrombosis
研究概览
简要总结
The rate of venous thromboembolic events in trauma patients at high risk for deep vein thrombosis and pulmonary embolism receiving low dose unfractionated heparin every 8 hours will be equivalent or less than a similar group of patients given a standard every 12 hour dose of low molecular weight heparin.
详细描述
Venous thromboembolism (VTE) is a common and potentially life threatening complication of major trauma. The risk of developing deep vein thrombosis (DVT) following major trauma exceeds 50% unless adequate chemoprophylaxis is used. Recent national quality improvement initiatives, such as the Surgical Care Improvement Project (SCIP), mandate the risk stratification of hospitalized patients and the use of VTE prophylaxis based on the risk assessment. Low Molecular Weight Heparin (LMWH, enoxaparin) and Low Dose Unfractionated Heparin (LDUH) are commonly used alternatives for VTE chemoprophylaxis following major trauma. LMWH became favored in most trauma centers following a prospective randomized controlled trial comparing the two agents that demonstrated superior efficacy and equivalent safety of LMWH over a twice per day dosing of LDUH. The results of this study were largely responsible for practice guideline recommendation changes favoring the use of LMWH in trauma patients by both the American College of Chest Physicians (ACCP) and the Eastern Association for the Surgery of Trauma (EAST). , This landmark paper did not, however, utilize a three times a day (every 8 hours) dosing of LDUH for prophylaxis, which is the dosing schedule recommended by earlier trials. LDUH administered every 8 hours was demonstrated to have similar efficacy to LMWH in trauma patients in a recent retrospective study. These results call into question the validity of the conclusions of the 1996 study. Because LDUH is less expensive ($0.50/dose) than LMWH (Enoxaparin, $28/dose), similar effectiveness would imply a significant reduction in the cost of prophylaxis and increased value to patients, providers and accountable care organizations and tax-payers.
To validate this hypothesis the investigators propose to achieve the following study objectives:
- Assess the degree of risk for VTE in each patient admitted to the trauma service
- Determine the rate of VTE events in high risk trauma patients receiving either:
- LMWH (30mg enoxaparin) given every twelve hours
- LDUH (5000 Units unfractionated Heparin) given every eight hours.
- Identify and quantify any adverse events associated with either treatment arm.
- Compare the value of LMWH versus LDUH in the prophylactic treatment of VTE disease in trauma patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Admitted to Scripps Mercy Trauma Service
- •≥18 Years old
- •Stratified to either Significant or Highest risk of VTE by ACCP guidelines
排除标准
- •Estimated Injury Severity Score (ISS) ≤9
- •Likely to be discharged before hospital day 7
- •Systemic coagulopathy defined with an International Normalized Ratio (INR) of ≥1.2
- •Body Mass Index (BMI) >40
- •Likely to Survive for <7 Days
- •Pregnancy
- •Evidence of renal insufficiency (Cr ≥1.3)
- •Delayed transfer to this facility (>24 hrs)
- •Prisoners
研究组 & 干预措施
5000 Units unfractionated Heparin Q 8 hr
Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
干预措施: 5000 Units unfractionated Heparin Q 8 hr (Drug)
30mg enoxaparin Q12 hr
Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.
干预措施: 30mg enoxaparin Q12 hr (Drug)
结局指标
主要结局
Lower Extremity Deep Vein Thrombosis
时间窗: Within 30 days of hospital admission
Patients will have a bilateral lower extremity duplex ultrasound performed by a registered vascular technologist twice per week if the patient is in the ICU, or once per week if the patient is on the trauma ward. All of the deep veins from the external iliac to and including the calf veins will be interrogated. Diagnosis of deep vein thrombosis (DVT) will be defined as absence of complete vein compressibility, presence of an echogenic thrombus within the vein, absence of color flow characteristics including lack of spontaneity, phasicity, pulsatility and augmentability as noted in the clinical practice guidelines of the American Thoracic Society. The vascular technologist and physician reading the ultrasound study will be blinded to the patient's enrollment status and randomization arm/medication group.
Pulmonary Embolus
时间窗: Within 30 days from admission to hospital
Patients with any or all of the following signs and symptoms suggestive of pulmonary embolism will have a CT angiogram (CTA) performed for diagnosis: Sudden onset of dyspnea, deterioration of existing dyspnea, decreased oxygen saturation (\<92%), onset of pleuritic chest pain without another apparent cause, onset of tachycardia (\>100), evidence of hypoxemia, hypocapnia, or respiratory alkalosis on arterial blood gas, or electrocardiographic changes reflecting right ventricular strain.
次要结局
- Heparin Induced Thrombocytopenia(Within 30 of admission to hospital)
- Bleeding Event(Within 30 days of admission to hospital)