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Идёт набор NCT05290857

Anticoagulation After GI Bleeding Pilot Study and Registry

Без фазы С лечением GastroIntestinal Bleeding Anticoagulant-induced Bleeding

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: Restart DOAC within 7 days of clinical hemostasis after GI bleeding, Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding.
Кому может быть актуально
Состояния в реестре: GastroIntestinal Bleeding, Anticoagulant-induced Bleeding. 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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Официальное название

Post-Bleed Management of Antithrombotic Therapy After Gastrointestinal Bleeding: Pilot Study and Registry (PANTHER-GI)

Обзор

PANTHER-GI Pilot Study will assess the feasibility of a full-scale multicentre cohort management study evaluating the safety of a standardized strategy for resuming direct oral anticoagulants (DOACs) after major DOAC-related gastrointestinal (GI) bleeding among patients at moderate to high risk of re-bleeding and thrombosis. A parallel registry will assess whether eligible patients who are not enrolled in the PANTHER-GI Pilot Study are systematically different than enrolled patients and to explore barriers to enrolment.

Подробное описание

This pilot cohort management study will evaluate a protocolized strategy for resuming DOACs after major GI bleeding based on thrombotic risk among patients at moderate to high risk of rebleeding. The timeframe for resuming DOACs will be determined based on the patient's underlying thrombotic risk.

Вмешательства

  • Другое Restart DOAC within 7 days of clinical hemostasis after GI bleeding
    In patients at high thrombotic risk, DOACs will be resumed within 7 days of clinical hemostasis (as judged by the clinical team). High thrombotic risk includes the following: (i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 5 or higher (ii) Atrial fibrillation or atrial flutter with CHA2DS2VASc score or 3 to 4 with recent ischemic stroke, TIA or systemic embolism (within 6 months) (iii) VTE (proximal DVT or PE) within 3 months (iv) Recurrent VTE (proximal DVT or PE) (v) VTE
  • Другое Restart DOAC between 7 to 14 days of clinical hemostasis after GI bleeding
    In patients at moderate thrombotic risk, DOACs will be resumed between 7 and 14 days of clinical hemostasis (as judged by the clinical team). Moderate thrombotic risk includes the following: (i) Atrial fibrillation or atrial flutter with CHA2DS2VASc score of 3 to 4 (ii) VTE (proximal DVT or PE) beyond 3 months The type and dose of DOAC will be according to patient and physician choice and will be prescribed by the clinical care team.

Первичные конечные точки

  • Recruitment rate [Срок оценки: 18 months]
  • Total recruitment [Срок оценки: 18 months]
Вторичные конечные точки (12)
  • eligibility [Срок оценки: 18 months]
  • consent [Срок оценки: 18 months]
  • completion of all required study procedures [Срок оценки: 18 months]
  • adherence [Срок оценки: 18 months]
  • repeat endoscopy [Срок оценки: 90 days]
  • re-hospitalization [Срок оценки: 90 days]
  • major bleeding [Срок оценки: 90 days]
  • clinically relevant non-major bleeding [Срок оценки: 90 days]
  • acute ischemic stroke, transient ischemic attack or systemic embolism [Срок оценки: 90 days]
  • acute symptomatic VTE [Срок оценки: 90 days]
  • net clinical benefit outcome rate [Срок оценки: 90 days]
  • all-cause mortality [Срок оценки: 90 days]

Критерии участия

Критерии включения

  • Male or female subjects aged 18 years or older
  • Hospitalized with acute major non-variceal GI bleeding (defined as per ISTH criteria) while receiving OAC therapy (warfarin or DOAC).
  • OAC therapy discontinued for current acute GI bleed and not yet resumed
  • Ongoing indication for long-term anticoagulation of atrial fibrillation (moderate to high risk of stroke/systemic embolism with CHA2DS2VASc score of 3 or higher) or VTE (as per clinical care team)
  • Planned to resume DOAC post-bleed
  • At moderate to high risk of re-bleeding as per clinical care team
  • Clinical hemostasis achieved as per clinical care team
  • Able and willing to comply with follow-up examinations contained within the consent form

Критерии исключения

  • Mechanical heart valve
  • VTE in the context of major transient risk factor and completed 3 months of treatment
  • GI bleeding managed surgically (e.g. gastrectomy, colectomy)
  • Active or previously treated gastrointestinal cancer
  • Life expectancy from other causes of less than 3 months
  • Platelet count < 50,000/µL (or < 50x109/L)
  • Renal dysfunction (Creatine Clearance <30 mL/min as calculated by the Cockcroft-Gault formula)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Канада · 2 центра
  • Alberta Health Services - Peter Lougheed Center Endoscopy Unit — Calgary
  • Ottawa Hospital Research Institute — Ottawa

Идентификаторы

NCT: NCT05290857 · 3349 20210798-01H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗