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

Ain Shams University25 enrolled

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

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Venous Thromboembolic Event

Interventions

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

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 assayOTHER

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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).

Locations (1)

Ain Shams University

Cairo, Abbassia, Egypt

RECRUITING

Outcomes

Primary Outcomes

VTE incidence

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

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

Secondary Outcomes

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.

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

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.

Time frame: 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.

Time frame: 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.

Central Contacts

Doaa Ahmed Diaa El din Ibrahim, MD

CONTACT

01128904628 Doaaeldin@med.asu.edu.eg

Data from ClinicalTrials.gov

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