NCT02984384已完成3 期
PREVENTion of Clot in Orthopaedic Trauma (PREVENT CLOT): A Randomized Pragmatic Trial Comparing the Complications and Safety of Blood Clot Prevention Medicines Used in Orthopaedic Trauma Patients
Major Extremity Trauma Research Consortium21 个研究点 分布在 2 个国家目标入组 12,424 人开始时间: 2017年4月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12,424
- 试验地点
- 21
- 主要终点
- Number of Participants With All-cause Mortality
研究概览
简要总结
The purpose of this study is to compare aspirin versus low-molecular weight heparin (LMWH) (Enoxaparin) as a thromboprophylaxis in patients who sustain a fracture.
详细描述
Patients who sustain orthopaedic trauma are at an increased risk of venous thromboembolism (VTE), including fatal pulmonary embolism (PE). Current guidelines recommend low-molecular-weight heparin (LMWH) for VTE prophylaxis in orthopaedic trauma patients. However, emerging literature in total joint arthroplasty patients suggests the potential clinical benefits of VTE prophylaxis with aspirin. This trial aims to determine if aspirin is non-inferior to LMWH for thromboprophylaxis in fracture 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
- •Patients who have a planned operative or non-operative pelvis or acetabular fracture, or any operative extremity fracture proximal to the metatarsals or carpals.
- •Patients at increased risk of blood clot(s) from their orthopaedic injury(ies) and will receive prophylactic blood thinner regimen per standard of care.
- •Patients 18 years or older.
排除标准
- •Patients who present to the hospital more than 48 hours post injury
- •Patients who received more than 2 doses of LMWH or aspirin for initial VTE prophylaxis
- •Patients on long term blood thinners (other than low-dose aspirin or platelet inhibitors such as Plavix or Aggrenox)
- •Patients who have had a VTE within the last 6 months
- •Patients on therapeutic (as opposed to prophylactic) blood thinners for an acute issue at the time of admission
- •Patients who have a newly diagnosed indication for therapeutic blood thinners (for example vascular injury) that will require therapeutic anticoagulation for more than one week
- •Patients who cannot receive either of the study medications due to an allergy (history of heparin induced thrombocytopenia, allergy to aspirin, or NSAIDs) or other medical contraindication to blood thinners
- •Patients who are on higher dose aspirin (>81 mg once a day or higher) for medical reasons or who will be treated with higher dose aspirin
- •Patients with underlying chronic clotting disorders (i.e. Factor V Leiden, hyperhomocysteinemia, Protein C and S deficiency) that require full dose anticoagulation or are a contraindication to venous thromboembolism chemoprophylaxis
- •Patients with end stage renal disease or impaired creatinine clearance <30 ml/min at time of randomization(note: creatinine clearance does not need to be documented if prescribing physician would order medication without test as SOC)
- •Pregnant or lactating patients
- •Prisoners
- •Patients who do not speak either English or Spanish
- •Patients who are likely to have severe problems maintaining follow-up
- •Patients, based upon the clinical judgment of the treating clinician, NOT equally suited for treatment with either aspirin or low-molecular-weight heparin
- •Patients may be excluded for other reasons at the discretion of the treating physician; the reason for exclusion must be documented on the screening form
- •Patients who have a known COVID-19 diagnosis prior to fracture treatment or within 3 months of the index fracture
研究组 & 干预措施
Low Molecular Weight Heparin (LMWH)-Enoxaparin
Active Comparator
Injection of 30 mg enoxaparin, twice a day via injection
干预措施: Low Molecular Weight Heparin (LMWH) (Drug)
Acetylsalicylic acid (ASA)-Aspirin
Active Comparator
Enteral ingestion or administration of 81 mg ASA, twice a day
干预措施: Acetylsalicylic acid (Drug)
结局指标
主要结局
Number of Participants With All-cause Mortality
时间窗: 90 days
Death from any cause
次要结局
- Deep Vein Thrombosis(90 days)
- Bleeding Complication(90 days)
- Wound Complication(90 days)
- Number of Participants With Cause-specific Death(90 days)
- Non-fatal Pulmonary Embolism(90 days)
- Deep Surgical Site Infection(90 days)
研究者
研究点 (21)
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