Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients
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: Ferric Derisomaltose 100 MG/ML, Sodium chloride.
- Кому может быть актуально
- Состояния в реестре: Iron Deficiency Anemia. Базовые параметры: от 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
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Intravenous Iron to Treat Postoperative Anemia in Older Cardiac Surgery Patients: a Randomized Controlled Trial'
Обзор
Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients. The objective of the study is to determine the effect of treatment of postoperative iron deficiency anemia with intravenous iron on disability 90 days after surgery. This will be evaluated in a randomized placebo-controlled double blind two-center trial in which 310 elective cardiac surgery patients will be included.
Подробное описание
Rationale: Postoperative anemia is common in cardiac surgery with cardiopulmonary bypass. Iron deficiency delays the recovery from postoperative anemia and may negatively affect the postoperative trajectory of cardiac surgery patients.
Objective: To determine the effect of treatment of postoperative iron deficiency anemia (IDA) with intravenous iron (IVI) on disability 90 days after surgery.
Study design: Randomized placebo-controlled double blind two-center trial
Study population: 310 elderly patients (≥70 years) with moderate postoperative IDA on postoperative day (POD) 1 (hemoglobin (Hb) 85 - 110 g/L, ferritin concentration \< 100 µg/L or iron saturation \<20%) after uncomplicated elective cardiac surgery (aortic valve repair (AVR) and coronary artery bypass graft (CABG) surgery).
Intervention: Postoperative treatment with a single dose IVI (ferric derisomaltose, Monofer®, N = 155) compared to postoperative treatment with sodium chloride (NaCL) 0.9% (placebo, N = 155).
Main study endpoints: Primary endpoint is disability as measured by the 12- item World Health Organization Disability Assessment score 2.0 (WHODAS-12 at POD 90 after elective cardiac surgery. Secondary endpoints are change in patient reported outcome measures (PROMs) related to dyspnea (assessed with the Rose Dyspnea Score (RDS)) and to health-related quality of life (HRQL) (assessed with The Older Persons and Informal Caregivers-Short Form (TOPICS-SF) questionnaire) at POD 90, the number of postoperative red blood cell (RBC) transfusions, change in reticulocyte hemoglobin content (pg) from randomization to hospital discharge, Hb levels at discharge, hospital complications and days alive and out of hospital at 90 days. Lastly, the difference in functional outcomes (e.g. steep ramp or 6-minute walk test) and Hb value at POD 90 will be assessed as an exploratory endpoint.
Вмешательства
- Препарат Ferric Derisomaltose 100 MG/ML
Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes. - Препарат Sodium chloride
Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.
Первичные конечные точки
- Disability [Срок оценки: 90 days after elective cardiac surgery]
Вторичные конечные точки (7)
- Change in patient reported outcome measures (PROMs) related to dyspnea [Срок оценки: 90 days after elective cardiac surgery]
- Change in patient reported outcome measures (PROMs) related to health related quality of life (HRQL) [Срок оценки: 90 days after elective cardiac surgery]
- Red blood cell transfusions [Срок оценки: +/- 7 days after elective cardiac surgery]
- Change in reticulocyte hemoglobin content [Срок оценки: +/- 7 days after elective cardiac surgery]
- Change in Hb level [Срок оценки: +/- 7 days after elective cardiac surgery]
- Postoperative complications [Срок оценки: +/- 7 days after elective cardiac surgery]
- Days alive and out of hospital [Срок оценки: 90 days after elective cardiac surgery]
Критерии участия
Критерии включения
- Mentally competent with age ≥ 70 years
- Elective AVR or CABG surgery
- Expected uncomplicated postoperative trajectory, defined as:
- No inotropic agents or ventilation at time of final inclusion (POD 1)
- Expected discharge to general ward at POD 1
- Moderate postoperative IDA, defined as:
- Hb between 85 and 110 g/L and
- Ferritin <100 µg/L or
- Iron saturation (TSAT) < 20%
Критерии исключения
- Medical history of iron overload/haemochromatosis
- Medical history of liver cirrhosis or ALT/AST value in blood serum triple of normal value (female patients: ALT >120, AST >105 U/L. Male patients: ALT>150, AST>135 U/L)
- Severe renal failure (eGFR<15ml/min/1.73m2)
- Recent treatment with IVI (<12 weeks prior)
- Serious or severe allergic reaction to IVI in medical history
- Severe asthma or eczema in medical history (atopic constitution)
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 2 центра
- Amphia Hospital — Breda
- St Antonius Hospital — Nieuwegein
Публикации
- Smoor RM, Rettig TCD, Vernooij LM, Groenewegen EM, van Dongen HPA, Noordzij PG. The effect of postoperative intravenous iron in anaemic, older cardiac surgery patients on disability-free survival (AGE ANEMIA study): study protocol for a multi-centre, double-blind, randomized, placebo-controlled trial. Trials. 2023 Oct 26;24(1):693. doi: 10.1186/s13063-023-07725-y. PMID 37885026
Идентификаторы
NCT: NCT04913649 · NL77442.100.21