Anti-Xa Guided Dosing of Low Molecular Weight Heparin for Prevention of Venous Thromboembolism Following Traumatic Injury: a Multicentre Pilot Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Recruitment (Patients per site per month)
研究概览
简要总结
This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether bloodwork guided dosing of blood thinners reduces the risk of clotting in high-risk trauma patients. Patients will receive either standard of care dosing or dosing with adjustments based on bloodwork to achieve a minimum therapeutic threshold.
详细描述
This multicentre pilot trial will assess the feasibility of a full-scale, randomized trial to determine whether anti-Xa guided dosing of low molecular heparin (LMWH) reduces the risk of venous thromboembolism (VTE) in high-risk trauma patients. Patients will receive either standard of care fixed dosing of Enoxaparin or 0.5 mg/kg twice daily with dose adjustments to achieve an anti-Xa trough level between 0.1 and 0.2 IU/mL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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 18 years of age or older admitted to a hospital ward or intensive care unit following a traumatic injury involving two or more body systems (head, chest, abdomen, pelvis, extremity) and meeting at least one of the following high-risk criteria previously identified in a recent systematic review (1): age ≥ 65, body mass index ≥ 30 kg/m2, injury severity score ≥ 16, pelvic injury with activity restrictions, lower extremity injury with activity restrictions, or surgery during the index hospitalization.
- •To be eligible, patients must be deemed appropriate for pharmacologic prophylaxis by the most responsible physician and randomized with the intention to receive prophylaxis within 48 hours of admission. Prior to randomization, there is no restriction on whether or not patients have previously received pharmacologic or mechanical prophylaxis.
排除标准
- •Greater than 7 days since time of injury.
- •Requirement for therapeutic anticoagulation or dual-antiplatelet therapy
- •Unable or unwilling to receive pharmacologic prophylaxis within 48 hours of admission.
- •History of allergic reaction or sensitivity to LMWH.
- •Thrombocytopenia with platelets <
- •Expected discharge or transfer from hospital within 72 hours.
研究组 & 干预措施
Standard of Care
Participants will receive Enoxaparin dosed at the discretion of the most responsible physician (MRP). In cases of severe renal insufficiency (CrCl < 30mL/min^:), the LMWH may dose reduced or changed to Heparin at the discretion of the MRP.
干预措施: Standard of Care Dosing (Drug)
Intervention (Anti-Xa Guided)
Participants will receive Enoxaparin 0.5 mg/kg twice daily (rounded up or down to the nearest 10 mg) the initial starting dose. Dose adjustments will be made based on trough levels drawn between the 3rd and 4th dose. The target anti-Xa level range is between 0.1 and 0.2 IU/mL. If the patient is below the target range, then the next Enoxaparin dose will be increased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. If the patient is above the target range, then the next Enoxaparin dose will be decreased by 10 mg per dose with a new trough anti-Xa level 24 hours after dose modification. This dose will be maintained until hospital discharge.
干预措施: Anti-Xa Guided Dosing of Low Molecular Weight Heparin (Drug)
结局指标
主要结局
Recruitment (Patients per site per month)
时间窗: Participants per site per month x 15 months
The pilot trial will have an expected duration of 15 months during which time we hope to enroll at least 150 participants total across all sites - therefore, 5 patients/site/month. There are no maximum enrollment targets for each site.
次要结局
- Eligibility rate(15 months)
- Consent rate(15 months)
- Adherence to monitoring(15 months)
- Retention rate(15 months)
- Study completion rate(15 months)
- Adherence rate(15 months)
- Adherence to dose adjustment(15 months)
- Adherence to anti-Xa target(15 months)
- Reasons for declining participation(15 months)
研究者
Alexandre Tran
Associate Scientist
Ottawa Hospital Research Institute