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

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

Study Overview

• Status: Recruiting
• Conditions: Venous Thromboembolic Event
• Intervention / Treatment: Other: follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay; Other: follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doaa Ahmed Diaa El din Ibrahim, MD; Phone Number: 01128904628; Email: Doaaeldin@med.asu.edu.eg

Study Locations

• Egypt
  • Abbassia
    • Cairo, Abbassia, Egypt, 00202
      • Recruiting
      • Ain Shams University
      • Contact: Doaa Ahmed Diaa Eldin Ibrahim, MD; Phone Number: 01128904628; Email: Doaaeldin@med.asu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control (weight based) group; 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; follow up of vte incidence with no routine dose modification unless indicated
Active Comparator: active antifactor xa based group; 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; follow up vte incidence and routine clexan dose modification

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients achieving target anti-factor Xa level	Proportion of burn patients (in percentage) receiving enoxaparin who achieve target anti-factor Xa level between 0.2 and 0.4 IU/mL during the study period.	From initiation of enoxaparin until 30 days post-burn injury or discharge from ICU, whichever occurs first
Incidence of Clinically Significant Bleeding Events	Number and percentage of patients experiencing clinically significant bleeding events during enoxaparin therapy. Bleeding events will be identified through medical record review. Logistic regression analysis will be performed to evaluate the association between peak anti-factor Xa level (IU/mL), measured using a chromogenic anti-factor Xa assay, and the occurrence of bleeding.	From initiation of enoxaparin until 30 days post-burn injury or ICU discharge, whichever occurs first
ICU Length of Stay (days)	Duration of ICU stay measured in days from ICU admission to ICU discharge. Linear regression analysis will be used to evaluate the relationship between mean anti-factor Xa level (IU/mL), measured using a chromogenic anti-factor Xa assay, and ICU length of stay.	During ICU stay, up to 30 days post-burn injury.
Thirty-Day All-Cause Mortality (%)	Percentage of patients who die from any cause within 30 days post-burn injury or prior to hospital discharge. Logistic regression analysis will be performed to evaluate the association between peak anti-factor Xa level (IU/mL), measured using a chromogenic anti-factor Xa assay, and 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)	Total daily enoxaparin dose (mg/day) required to achieve a target anti-factor Xa level of 0.2-0.4 IU/mL, measured using a chromogenic anti-factor Xa assay. Linear regression analysis will be used to evaluate predictors of dose requirement.	During ICU stay, up to 30 days
Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL)	Pearson or Spearman correlation coefficient will be calculated to assess the relationship between baseline body weight (kg) and peak anti-factor Xa level (IU/mL), measured using a chromogenic anti-factor Xa assay.	Baseline and during ICU stay, up to 30 days
Correlation Between Serum Creatinine (mg/dL) and Peak Anti-Factor Xa Level (IU/mL)	Pearson or Spearman correlation coefficient will be calculated to assess the relationship between serum creatinine (mg/dL) and peak anti-factor Xa level (IU/mL), measured using a chromogenic anti-factor Xa assay.	Baseline and during ICU stay, up to 30 days
Correlation Between Total Body Surface Area Burned (%) and Peak Anti-Factor Xa Level (IU/mL)	Pearson or Spearman correlation coefficient will be calculated to assess the relationship between total body surface area burned (%) and peak anti-factor Xa level (IU/mL), measured using a chromogenic anti-factor Xa assay.	Baseline and during ICU stay, up to 30 days.

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FMASU MD380/2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No