NCT07464808招募中不适用
Utilizing Anti-Factor Xa as a Predictive Tool for Optimizing Outcome in Burn Patients' Management
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- VTE incidence
研究概览
简要总结
This study aims to compare the efficacy of anti-Xa based versus weight-based enoxaparin dosing and to evaluate anti-Xa levels as a predictive tool for clinical outcomes in burn patients
详细描述
This study aims to compare the efficacy of anti-Xa based versus weight-based enoxaparin dosing and to evaluate anti-Xa levels as a predictive tool for clinical outcomes in burn patients, Patients will be randomized 1:1 to either anti-Xa-based or weight-based enoxaparin dosing.
Group 1 (weight-based):
- Enoxaparin (subcutaneously) adjusted for weight: 1mg/kg twice daily.
- For obese and morbidly obese patients, 1 mg/kg Q 12 h dose will be given up to weights of approximately 150 kg. The maximum dose of enoxaparin should be 150 mg SC Q 12 h.
- Patients weighing < 45 kg were not included in clinical trials; therefore, these patients should also be monitored using the low molecular weight heparin assay.
- No routine anti-Xa monitoring unless clinically indicated.
Group 2 (anti-Xa-based):
- Initial dose as standard: 1mg/kg twice daily; peak anti-Xa level measured 4 hours after third dose, Target: 0.2-0.4 IU/ml for prophylaxis.
- Adjustments: Increase by 10 mg if <0.2 IU/mL; decrease by 10 mg if >0.4 IU/ml.
- Re-check after 3 modified doses until the target level is achieved.
- Prophylaxis continues until mobilization or discharge.
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 (Care Provider)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥21 years) admitted to the burn unit with thermal burns ≥20% TBSA and < 60%.
- •Admission to BICU within 48 hours of burn injury.
- •Indication for VTE prophylaxis (e.g., immobilized, surgical intervention).
- •Ability to provide informed consent
排除标准
- •Pre-existing coagulopathy or anticoagulant therapy prior to injury.
- •Patients with severe comorbidities (e.g., end-stage renal failure, advanced malignancy, hepatic disease).
- •Need for therapeutic anticoagulant therapy.
- •patients with extremes of weight, (45kg >=weight >= 150kg).
研究组 & 干预措施
control (weight based) group
Active Comparator
Group 1 (weight-based):
- Enoxaparin (subcutaneously) adjusted for weight: 1mg/kg twice daily.
- For obese and morbidly obese patients, 1 mg/kg Q 12 h dose will be given up to weights of approximately 150 kg. The maximum dose of enoxaparin should be 150 mg SC Q 12 h.
- Patients weighing < 45 kg were not included in clinical trials; therefore, these patients should also be monitored using the low molecular weight heparin assay.
- No routine anti-Xa monitoring unless clinically indicated. follow up of venous thrombo embolic events.
干预措施: follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay (Other)
active antifactor xa based group
Active Comparator
Group 2 (anti-Xa-based):
- Initial dose as standard: 1mg/kg twice daily; peak anti-Xa level measured 4 hours after third dose, Target: 0.2-0.4 IU/ml for prophylaxis
- Adjustments: Increase by 10 mg if <0.2 IU/mL; decrease by 10 mg if >0.4 IU/ml
- Re-check after 3 modified doses until the target level is achieved.
- Prophylaxis continues until mobilization or discharge follow up of venous thrombo embolic events.
干预措施: follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay (Other)
结局指标
主要结局
VTE incidence
时间窗: from incidence of burn injury and start of anticoagulation till 30day post burn or till discharge from ICU
Incidence of 30-day symptomatic VTE (confirmed by Doppler ultrasound or CT angiography) in anti-Xa-guided vs. fixed-dose enoxaparin group
次要结局
- Proportion of patients achieving target anti-factor Xa level(From initiation of enoxaparin until 30 days post-burn injury or discharge from ICU, whichever occurs first)
- Incidence of Clinically Significant Bleeding Events(From initiation of enoxaparin until 30 days post-burn injury or ICU discharge, whichever occurs first)
- ICU Length of Stay (days)(During ICU stay, up to 30 days post-burn injury.)
- Thirty-Day All-Cause Mortality (%)(Up to 30 days post-burn injury or hospital discharge, whichever occurs first)
- Total Daily Enoxaparin Dose Required to Achieve Target Anti-Factor Xa Level (mg/day)(During ICU stay, up to 30 days)
- Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL)(Baseline and during ICU stay, up to 30 days)
- Correlation Between Serum Creatinine (mg/dL) and Peak Anti-Factor Xa Level (IU/mL)(Baseline and during ICU stay, up to 30 days)
- Correlation Between Total Body Surface Area Burned (%) and Peak Anti-Factor Xa Level (IU/mL)(Baseline and during ICU stay, up to 30 days.)
研究者
研究点 (1)
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