Venous Thromboembolic EventNCT07464808
Utilizing Anti-Factor Xa as a Predictive Tool for Optimizing Outcome in Burn Patients' Management
A study testing follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay and follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay in people with Venous Thromboembolic Event, run by Ain Shams University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Venous Thromboembolic Event
- What is being tested?
- follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay and follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Nov 2025to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University
Cairo, Abbassia, 00202
Doaa Ahmed Diaa Eldin Ibrahim, MD, 01128904628, Doaaeldin@med.asu.edu.eg
About this study
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
Read the 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.
- Conditions
- Venous Thromboembolic Event
- Being tested
- follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay, follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| control (weight based) group | Active comparator | 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. follow up of venous thrombo embolic events. Receives: Other: follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay |
| active antifactor xa based group | Active comparator | 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 follow up of venous thrombo embolic events. Receives: Other: follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE incidence
Incidence of 30-day symptomatic VTE (confirmed by Doppler ultrasound or CT angiography) in anti-Xa-guided vs. fixed-dose enoxaparin group
Measured: from incidence of burn injury and start of anticoagulation till 30day post burn or till discharge from ICU
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and during ICU stay, up to 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start28 Nov 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Thromboembolic EventStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07464808
- Sponsor's protocol ID
- FMASU MD380/2025
- Status last verified
- Feb 2026
- First submitted
- 24 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Anti-Factor Xa as a Predictive Tool for Optimizing Outcome in Burn Patients' Management
- ClinicalTrials.gov ID
- NCT07464808
- Acronym / sponsor ID
- FMASU MD380/2025
- Conditions
- Venous Thromboembolic Event
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 28 Nov 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control (weight based) group | Active comparator | Other: follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assayGroup 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. follow up of venous thrombo embolic events. |
| active antifactor xa based group | Active comparator | Other: follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assayGroup 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 follow up of venous thrombo embolic events. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assayfollow up vte incidence and routine clexan dose modification | Other | active antifactor xa based group |
| follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assayfollow up of vte incidence with no routine dose modification unless indicated | Other | control (weight based) group |
Primary outcome
VTE incidence
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
8 secondary outcomes
Proportion of patients achieving target anti-factor Xa level
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
Time frame: From initiation of enoxaparin until 30 days post-burn injury or ICU discharge, whichever occurs first
ICU Length of Stay (days)
Time frame: During ICU stay, up to 30 days post-burn injury.
Thirty-Day All-Cause Mortality (%)
Time frame: 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)
Time frame: During ICU stay, up to 30 days
Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL)
Time frame: Baseline and during ICU stay, up to 30 days
Correlation Between Serum Creatinine (mg/dL) and Peak Anti-Factor Xa Level (IU/mL)
Time frame: Baseline and during ICU stay, up to 30 days
Correlation Between Total Body Surface Area Burned (%) and Peak Anti-Factor Xa Level (IU/mL)
Time frame: Baseline and during ICU stay, up to 30 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing follow up venous thrombo embolic events with routine clexan dose modification guided by anti factor 10 assay and follow up venous thromboembolic events with no routine clexan dosage modification and no usage of anti factor 10 assay in people with Venous Thromboembolic Event, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doaa Ahmed Diaa El din Ibrahim, MD (01128904628, Doaaeldin@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VTE incidence (time frame: from incidence of burn injury and start of anticoagulation till 30day post burn or till discharge from ICU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.