Набор скоро начнётся NCT06153394

Prolonged Hypercoagulability Following Major Liver Resection for Malignancy

Фаза III С лечением Hepatic Disease Surgery-Complications Hypercoagulability Thrombosis

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: Redesca (enoxaparin sodium for injection), Fragmin (dalteparin).
Кому может быть актуально: Состояния в реестре: Hepatic Disease, Surgery-Complications, Hypercoagulability, Thrombosis. 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: Канада
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 clinical trial will investigate the ability of thromboelastrogrpahy (TEG®) to detect hypercoagulability after liver surgery and will examine the effect of extended thromboprophylaxis (medical treatment to prevent the development of blood clots inside blood vessels) in patients undergoing liver surgery for cancer treatment. The liver plays a key role in regulating the process of blood clotting. As a result, blood clots are a major cause of complications and death following liver surgery. This is especially true in cancer patients who are at a higher risk of developing blood clots. Current methods for preventing clotting complications after liver surgery include conventional coagulation blood tests (CCTs) and anticoagulant drugs, such as low molecular weight heparins (LMWHs). Current LMWH treatment is prescribed for one month after surgery, but studies show that the risk of developing blood clots can last up to 3 months. Studies also show that CCTs may not be as effective in detecting clotting issues as more comprehensive testing systems, such as TEG. This study will randomize 50 participants to receive 90 days of thromboprophylaxis (using the LMWH Redesca) or the standard of care 30 days (using the LMWH Fragmin) after liver surgery. The medication will be given by injection, similar to a regular vaccine or an insulin injection. Participants will inject the medication every day, for 30 or 90 days, after surgery. Participants will also have their blood tested for clotting issues via TEG testing before surgery and on post-operative days 1,3,5,30 and 90. After surgery, participants will be monitored by their surgeon for clotting complications and 3 year disease-free survival.

Вмешательства

Препарат Redesca (enoxaparin sodium for injection)
Redesca is low molecular weight heparin and a biosimilar biologic drug (biosimilar) to Lovenox. Indications have been granted on the basis of similarity between Redesca and the reference biologic drug Lovenox. As such, Redesca (enoxaparin sodium) is indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield.
Препарат Fragmin (dalteparin)
Fragmin is a low molecular weight heparin indicated for thromboprophylaxis in patients undergoing high risk abdominal and colorectal surgeries. Doses are provided as self-administered subcutaneous injections using a pre-filled syringe with a protective shield. Our institution uses this drug for standard of care thromboprophylaxis (30 days) in this patient population.

Первичные конечные точки

Number pf participants with hypercoagulability identified via TEG testing [Срок оценки: Preoperatively (with pre-admission blood work) through to 90 days postoperatively]

Вторичные конечные точки (2)

Thrombotic Events [Срок оценки: Up to 6 months postoperatively]
Disease Free Survival [Срок оценки: Up to 3 years postoperatively]

Критерии участия

Критерии включения

Adults aged 18 years or older at the time of enrollment.
Requiring major liver resection (>2 liver sections) for any oncologic indication.
Requiring postoperative thromboprophylaxis will be included.
Willing and able to perform subcutaneous injections according to the study protocol, or receive injections form a caregiver delegated by the participant.