Anti‑Factor Xa–guided enoxaparin dosing for preventing blood clots in adults with major burns

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

This trial will test whether using anti‑Factor Xa blood levels to guide enoxaparin dosing prevents venous blood clots better than standard weight‑based dosing in adults with moderate-to-large thermal burns.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: Ain Shams University (Academic / other)
• Locations: 1 site (Cairo, Abbassia)
• Trial ID: NCT07464808 on ClinicalTrials.gov

What this trial studies

Adults with thermal burns covering 20–60% total body surface area who are admitted within 48 hours and need VTE prophylaxis are randomized 1:1 to weight‑based enoxaparin (1 mg/kg twice daily, max 150 mg) or anti‑Xa‑guided dosing. In the anti‑Xa arm a peak level is measured 4 hours after the third dose with a prophylactic target of 0.2–0.4 IU/mL and dose adjustments of ±10 mg are made until the target is reached. The weight‑based arm receives standard dosing without routine anti‑Xa monitoring. Prophylaxis continues until mobilization or hospital discharge and patients are followed for venous thromboembolic events.

Who should consider this trial

Good fit: Adults aged 21 or older with thermal burns of 20–60% TBSA admitted to the burn ICU within 48 hours who require VTE prophylaxis and can provide consent are ideal candidates.

Not a fit: Patients with pre-existing coagulopathy or on prior anticoagulation, those with severe comorbidities (like end‑stage renal failure or advanced liver disease), those needing therapeutic anticoagulation, and patients with very low or very high body weight (e.g., <45 kg or ≥150 kg) are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If successful, tailoring enoxaparin by anti‑Factor Xa levels could lower the risk of VTE and optimize dosing safety for burn patients.

How similar studies have performed: Anti‑Xa‑guided dosing has produced mixed results in other surgical and trauma populations and remains relatively untested specifically in burn patients.

Eligibility criteria

Inclusion Criteria:

1. Adults (≥21 years) admitted to the burn unit with thermal burns ≥20% TBSA and \< 60%.
2. Admission to BICU within 48 hours of burn injury.
3. Indication for VTE prophylaxis (e.g., immobilized, surgical intervention).
4. Ability to provide informed consent

Exclusion Criteria:

1. Pre-existing coagulopathy or anticoagulant therapy prior to injury.
2. Patients with severe comorbidities (e.g., end-stage renal failure, advanced malignancy, hepatic disease).
3. Need for therapeutic anticoagulant therapy.
4. patients with extremes of weight, (45kg \>=weight \>= 150kg).

Where this trial is running

Cairo, Abbassia

• Ain Shams University — Cairo, Abbassia, Egypt (Recruiting)

Study contacts

• Study coordinator: Doaa Ahmed Diaa El din Ibrahim, MD

Conditions Venous Thromboembolic Event