Ain Shams University
Cairo, Abbassia, 00202, Egypt
Location status: Recruiting
NCT Number: NCT07464808
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
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All sexes
Interventional
Not applicable
Cairo, Abbassia, 00202, Egypt
Location status: Recruiting
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):
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
follow up vte incidence and routine clexan dose modification
follow up of vte incidence with no routine dose modification unless indicated
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
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.
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.
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
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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.
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