Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07464808

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

Recruiting

Interested in participating?

Request Info

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Abbassia, 00202, Egypt

Location status: Recruiting

Location contact

Doaa Ahmed Diaa Eldin Ibrahim, MD

CONTACT

[email protected]

01128904628

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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).

Treatment and study plan

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

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

Primary outcomes

  1. VTE incidence

    Time frame: 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

Secondary outcomes

  1. Proportion of patients achieving target anti-factor Xa level

    Time frame: From initiation of enoxaparin until 30 days post-burn injury or discharge from ICU, whichever occurs first

    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.

  2. Incidence of Clinically Significant Bleeding Events

    Time frame: From initiation of enoxaparin until 30 days post-burn injury or ICU discharge, whichever occurs first

    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.

  3. ICU Length of Stay (days)

    Time frame: During ICU stay, up to 30 days post-burn injury.

    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.

  4. Thirty-Day All-Cause Mortality (%)

    Time frame: Up to 30 days post-burn injury or hospital discharge, whichever occurs first

    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.

  5. Total Daily Enoxaparin Dose Required to Achieve Target Anti-Factor Xa Level (mg/day)

    Time frame: During ICU stay, up to 30 days

    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.

  6. Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL)

    Time frame: Baseline and during ICU stay, up to 30 days

    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.

  7. Correlation Between Serum Creatinine (mg/dL) and Peak Anti-Factor Xa Level (IU/mL)

    Time frame: Baseline and during ICU stay, up to 30 days

    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.

  8. Correlation Between Total Body Surface Area Burned (%) and Peak Anti-Factor Xa Level (IU/mL)

    Time frame: Baseline and during ICU stay, up to 30 days.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Doaa Ahmed Diaa El din Ibrahim, MD

CONTACT

[email protected]

01128904628

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.