Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis
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: Dabigatran, Enoxaparin.
- Кому может быть актуально
- Состояния в реестре: Portal Vein Thrombosis, Liver Cirrhosis. Базовые параметры: 18 лет — 70 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
- Индия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Compare the Efficacy and Safety of Dabigatran and Enoxaparin in Patients With Portal Vein Thrombosis With Cirrhosis: A Randomized Controlled Study
Обзор
Portal vein thrombosis (PVT) is prevalent among patients with cirrhosis, and its prevalence rises with the severity of liver disease. Numerous studies have indicated that patients developing PVT experience elevated portal pressure and associated complications, such as increased incidence of variceal bleeding, higher rates of failed variceal bleed control, rebleeding, and short-term mortality. Additionally, the development of PVT adversely affects post-transplant outcomes, correlating with increased 30-day mortality among transplant recipients with PVT. Current guidelines lack clarity regarding the optimal choice of anticoagulation therapy for patients with cirrhosis. This study aims to evaluate the efficacy and safety of enoxaparin and dabigatran in achieving complete recanalization of portal vein thrombosis in cirrhotic patients over a 6-month period.
Подробное описание
Study population: Cirrhosis with portal vein thrombosis within 6 months of diagnosis of portal vein thrombus Study design - A prospective, randomized, single center open label study Block Randomization, block size - 10 Study site - Department of Hepatology, ILBS, New Delhi from The study will be conducted on the consecutive patients with liver cirrhosis with portal vein thrombosis.
Study period -1 year Monitoring and assessment
* At enrollment:
1. Complete history and physical examination 2. Etiology of cirrhosis 3. Presenting symptoms 4. Severity of ascites, Jaundice 5. Pattern and number of prior decompensation 6. UGIE and variceal status 7. Complete physical evaluation 8. Hemogram, Kidney function test, Liver function test, INR 9. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen 10. Fibroscan-liver and spleen 11. 2D-ECHO, ECG 12. AFP At follow-up (1month, 3 month, 6 month, 9 month 12month)
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1. Complete history and physical examination 2. Pattern and number of decompensation 3. MELD, CTP, APRI, ALBI Score 4. Hemogram, Kidney function test, Liver function test, INR 5. Ultrasound abdomen with spleno-portal axis doppler / CECT upper abdomen
Вмешательства
- Препарат Dabigatran
Dabigatran 150 mg BD fixed dose to be given for duration of 6 months. - Препарат Enoxaparin
Enoxaparin . Treatment would be given with 1 mg /Kg (100IU/Kg) dose s/c twice daily for 6 months.
Первичные конечные точки
- Proportion of patients achiving recanalization of Portal Vein Thrombosis (PVT) in cirrhosis patients at 6-months in both groups. [Срок оценки: 6 months]
Вторичные конечные точки (11)
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. [Срок оценки: 6 months]
- Rate of partial recanalization of Portal Vein Thrombosis in cirrhosis patients at 6-months in between groups. [Срок оценки: 6 months]
- Rate of complete recanalization of Portal Vein Thrombosis in cirrhosis patients at 3-months in between groups. [Срок оценки: 3 months]
- Rate of recurrence of Portal Vein Thrombosis at 12 months. [Срок оценки: 12 months]
- Adverse events in both the groups till 6-months [Срок оценки: 6 months]
- Change in CTP scores in both the groups over 12-months [Срок оценки: 12-months]
- Change in MELD scores in both the groups over 12-months [Срок оценки: 12-months]
- Variceal and non-variceal bleeding rates at 6-months and 12-months [Срок оценки: 6-months and 12-months]
- Number of patients with worsening of decompensation events and new onset decompensation events in the two study groups till 12-months [Срок оценки: 12-months]
- Baseline parameters for predicting recanalisation of Portal Vein Thrombosis (PVT) at 6 months in both the groups. [Срок оценки: 12 months]
- Baseline parameters for predicting rethrombosis of PVT at 12 months in both the groups. [Срок оценки: 12 months]
Критерии участия
Критерии включения
- Age >18 years
- Cirrhosis with portal vein thrombosis within 6 months of diagnosis/Symptomatic PVT/PVT in potential transplant recipient.
Критерии исключения
- Contraindications to anticoagulant therapy, such as active bleeding, recent major surgery, or known hypersensitivity to study medications.
- CTP >10
- Hepatocellular carcinoma
- Tumoral PVT
- Isolated gastric varices with red colour signs
- Peptic ulcer disease with large ulcers
- Pregnant or breastfeeding women
- Thrombocytopenia (platelet count <50,000/μL)
- Patients with concurrent acute kidney injury or chronic kidney disease stage 4 or 5
- Those not giving consent for therapy
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
- Открытое
- Основная цель
- Лечение
Центры проведения
Индия · 1 центр
- Institute of Liver & Biliary Sciences (ILBS) — New Delhi
Идентификаторы
NCT: NCT06818279 · ILBS-Cirrhosis-72