Utilizing Anti-Factor Xa as a Predictive Tool for Optimizing Outcome in Burn Patients' Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay, follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay.
- Who it may be relevant to
- Registry conditions: Venous Thromboembolic Event. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
Primary outcome measures
- VTE incidence [Time frame: from incidence of burn injury and start of anticoagulation till 30day post burn or till discharge from ICU]
Secondary outcome measures (8)
- 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]
- Incidence of Clinically Significant Bleeding Events [Time frame: From initiation of enoxaparin until 30 days post-burn injury or ICU discharge, whichever occurs first]
- ICU Length of Stay (days) [Time frame: During ICU stay, up to 30 days post-burn injury.]
- Thirty-Day All-Cause Mortality (%) [Time frame: 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) [Time frame: During ICU stay, up to 30 days]
- Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL) [Time frame: Baseline and during ICU stay, up to 30 days]
- 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]
- 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.]
Eligibility criteria
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Egypt · 1 center
- Ain Shams University — Cairo
Identifiers
NCT: NCT07464808 · FMASU MD380/2025