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

ConditionVenous Thromboembolic Event
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorAin Shams University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Other intervention

    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 assay

    Other intervention

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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: control (weight based) groupActive comparator 1 intervention
Group B: active antifactor xa based groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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.
4

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.

Time frame
Up to 30 days post-burn injury or hospital discharge, whichever occurs first

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov
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