Utilizing Anti-Factor Xa as a Predictive Tool for Optimizing Outcome in Burn Patients' Management
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: 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.
- Кому может быть актуально
- Состояния в реестре: Venous Thromboembolic Event. Базовые параметры: от 21 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Египет
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
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
Подробное описание
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.
Вмешательства
- Другое follow 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 - Другое follow 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
Первичные конечные точки
- VTE incidence [Срок оценки: from incidence of burn injury and start of anticoagulation till 30day post burn or till discharge from ICU]
Вторичные конечные точки (8)
- Proportion of patients achieving target anti-factor Xa level [Срок оценки: From initiation of enoxaparin until 30 days post-burn injury or discharge from ICU, whichever occurs first]
- Incidence of Clinically Significant Bleeding Events [Срок оценки: From initiation of enoxaparin until 30 days post-burn injury or ICU discharge, whichever occurs first]
- ICU Length of Stay (days) [Срок оценки: During ICU stay, up to 30 days post-burn injury.]
- Thirty-Day All-Cause Mortality (%) [Срок оценки: 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) [Срок оценки: During ICU stay, up to 30 days]
- Correlation Between Body Weight (kg) and Peak Anti-Factor Xa Level (IU/mL) [Срок оценки: Baseline and during ICU stay, up to 30 days]
- Correlation Between Serum Creatinine (mg/dL) and Peak Anti-Factor Xa Level (IU/mL) [Срок оценки: Baseline and during ICU stay, up to 30 days]
- Correlation Between Total Body Surface Area Burned (%) and Peak Anti-Factor Xa Level (IU/mL) [Срок оценки: Baseline and during ICU stay, up to 30 days.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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).
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Профилактика
Центры проведения
Египет · 1 центр
- Ain Shams University — Cairo
Идентификаторы
NCT: NCT07464808 · FMASU MD380/2025