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

NCT07464808 | Recruiting

• 1 other identifier: FMASU MD380/2025
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Venous Thromboembolic Event

Outcome Measures

Primary Outcomes (1)

• VTE incidence

  Incidence of 30-day symptomatic VTE (confirmed by Doppler ultrasound or CT angiography) in anti-Xa-guided vs. fixed-dose enoxaparin group

  from incidence of burn injury and start of anticoagulation till 30day post burn or till discharge from ICU

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Other: follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay

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.

Other: follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay

Interventions

follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay OTHER

follow up vte incidence and routine clexan dose modification

active antifactor xa based group

follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay OTHER

follow up of vte incidence with no routine dose modification unless indicated

control (weight based) group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 00202, Egypt

RECRUITING

Central Study Contacts

Doaa Ahmed Diaa El din Ibrahim, MD

CONTACT

01128904628; Doaaeldin@med.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: March 11, 2026
• Study Start: November 28, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-02

Locations

EG (1)