Идёт набор NCT07461545

Efficacy of Apixaban in the Treatment of Portal Vein Thrombosis Occurring More Than One Year After LS

Без фазы С лечением Cirrhosis Splenectomy Portal Vein Thrombosis Hypertension, Portal

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: Apixaban 2.5 MG.
Кому может быть актуально: Состояния в реестре: Cirrhosis, Splenectomy, Portal Vein Thrombosis, Hypertension, Portal. Базовые параметры: от 18 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: Китай
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

Efficacy of Apixaban in Treating Portal Vein Thrombosis Occurring More Than One Year After Laparoscopic Splenectomy

Обзор

The purpose of this study is to determine whether Apixaban is effective and safe in the treatment of portal vein thrombosis Occurring more than one year after laparoscopic splenectomy.

Подробное описание

If portal vein thrombosis occurs more than one year after laparoscopic splenectomy, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, the efficacy of apixaban in treating portal vein thrombosis will be examined every three months using Doppler ultrasound screening or contrast-enhanced CT scans. If it is effective, the patient will continue to take apixaban.

Вмешательства

Препарат Apixaban 2.5 MG
If portal vein thrombosis occurs more than one year after laparoscopic splenectomy, the patient will orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily. Then, Doppler ultrasound screening or contrast-enhanced CT scans will be used to evaluate the changes in portal vein thrombosis after apixaban treatment. If it is effective, patients will take apixaban all the time.

Первичные конечные точки

Proportion of complete recanalization of portal vein thrombosis [Срок оценки: Follow-up of 6 months or greater]

Вторичные конечные точки (1)

Proportion of partial recanalization of portal vein thrombosis [Срок оценки: Follow-up of 6 months or greater]

Критерии участия

Критерии включения

A clinical, radiological, or histologic diagnosis of cirrhosis of any etiology.
Splenomegaly with secondary hypersplenism.
No evidence of portal vein thrombosis by ultrasound evaluation and angio-CT prior to surgery.
Underwent laparoscopic splenectomy at our center.
Orally received 2.5 mg of apixaban (CTTQ, Nanjing, China) twice daily or a 100 mg aspirin tablet (Bayer, Leverkusen, Germany) once daily for 6 months from POD 3.
subcutaneous injections of low molecular weight heparin sodium (CSBio, Hebei, China) were administered for 5 days from POD 3
Oral dipyridamole (Henan Furen, Henan, China) at a dosage of 25 mg, administered three times daily for 3 months from POD 3.
Had no imaging evidence (Doppler ultrasound or CT) of portal vein thrombosis during postoperative months 6 to 12.
Developed portal vein thrombosis after 12 months post-surgery.
Provided informed consent to participate in the study.