Venous Thromboembolic Event
Conditions
Brief summary
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
OTHERfollow 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
OTHERfollow 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
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VTE incidence | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients achieving target anti-factor Xa level | 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. |
| Incidence of Clinically Significant Bleeding Events | 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. |
| ICU Length of Stay (days) | 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. |
| Thirty-Day All-Cause Mortality (%) | 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. |
| Total Daily Enoxaparin Dose Required to Achieve Target Anti-Factor Xa Level (mg/day) | 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. |
| Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL) | 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. |
| Correlation Between Serum Creatinine (mg/dL) and Peak Anti-Factor Xa Level (IU/mL) | 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. |
| Correlation Between Total Body Surface Area Burned (%) and Peak Anti-Factor Xa Level (IU/mL) | 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. |
Countries
Egypt
Contacts
CONTACTDoaa Ahmed Diaa El din Ibrahim, MD
Outcome results
None listed