Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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):
Group 2 (anti-Xa-based):
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control (weight based) group | Active Comparator | Group 1 (weight-based):
|
|
| active antifactor xa based group | Active Comparator | Group 2 (anti-Xa-based):
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Doaa Ahmed Diaa El din Ibrahim, MD | Contact | 01128904628 | Doaaeldin@med.asu.edu.eg |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | Abbassia | 00202 | Egypt |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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. |