NCT07464808

Utilizing Anti-Factor Xa as a Predictive Tool for Optimizing Outcome in Burn Patients' Management

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Venous Thromboembolic Event

Interventions

Type	Name	Description
OTHER	follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay	follow up vte incidence and routine clexan dose modification
OTHER	follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay	follow up of vte incidence with no routine dose modification unless indicated

Timeline

• Start date: 2025-11-28
• Primary completion: 2027-01-30
• Completion: 2027-11-30
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Egypt