Tranexamic Acid for Anaemia Trial
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: Tranexamic Acid 500 MG, Matched placebo.
- Кому может быть актуально
- Состояния в реестре: Anemia. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- 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
The Effects of Tranexamic Acid on Anaemia, Menstrual Health and the Wellbeing of Women: an International Randomised, Placebo-controlled Trial Among Menstruating Women With Anaemia
Обзор
Anaemia is a common health problem in women. It is often due to iron deficiency. Anaemia is a particular problem during pregnancy and is bad for the mother and baby. It is best to treat anaemia in young women well before they get pregnant. Doctors treat anaemia with iron and vitamins. But some people get side effects when taking iron tablets and so they stop taking them. Heavy menstrual periods are a common cause of iron deficiency and even if women do take iron, because they lose so much iron in their periods, they still become iron deficient. Tranexamic acid (TXA) is a medicine used to treat heavy periods. The investigators of this study would like to find out if taking TXA with the usual iron and vitamin supplements is better at treating anaemia than taking iron and vitamin supplements alone. (Lay Summary)
Подробное описание
World-wide, half a billion women of reproductive age are anaemic. Anaemia has major health consequences for pregnant women and their babies. Anaemia increases the risk of ante-partum haemorrhage, prematurity, stillbirth, neonatal death, post-partum haemorrhage and maternal death. Early intervention to reduce the risk of anaemia before pregnancy offers the potential to reduce adverse maternal and birth outcomes and improve well-being across the reproductive life course.
Unfortunately, global efforts to reduce anaemia prevalence by 2025 are far off track. Anaemia worsens bleeding through multiple biological mechanisms. Anaemia increases blood flow from bleeding vessels due to reduced blood viscosity and anaemic blood clots are more susceptible to fibrinolysis. Although iron and multivitamin replacement is the mainstay of anaemia treatment, iron stores in young women depend more on menstrual iron loss than on dietary intake. Because anaemia worsens bleeding, women with anaemia have heavier menstrual periods than if they were not anaemic. For this reason, offering iron replacement without reducing menstrual iron loss may be inefficient.
The antifibrinolytic tranexamic acid (TXA) reduces menstrual bleeding by preventing blood clot breakdown. The investigators propose that giving TXA with iron and vitamin replacement will be more effective in treating anaemia than iron and vitamin replacement alone.
Вмешательства
- Препарат Tranexamic Acid 500 MG
Tablets - Другое Matched placebo
Matched placebo tablets (inactive ingredients only, including microcrystalline cellulose, magnesium stearate BP and lactose)
Первичные конечные точки
- Anaemia [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
Вторичные конечные точки (10)
- Haemoglobin (Hb) concentration [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Severity of anaemia [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Ferritin [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Iron deficiency [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- C-reactive protein (CRP) [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Iron-deficiency anaemia [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Menstrual blood loss [Срок оценки: During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)]
- Perceived change in menstrual blood loss [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Degree of effect of menstrual bleeding on health-related Quality of Life [Срок оценки: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.]
- Flooding [Срок оценки: During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)]
Критерии участия
Критерии включения
- Adult women (aged 18 years and older)
- Having menstrual periods every 21 to 38 days that last 2 to 9 days
- Having anaemia (Hb < 120 g/L) according to point-of-care finger prick screening test
- Willing to provide informed consent and able to attend study visits during the trial period
(Individuals with known thalassaemia are eligible to participate and take the trial treatment but will not receive standard of care iron supplementation. They will continue to receive their standard care.)
Критерии исключения
- Planning to get pregnant during trial period
- Already taking TXA
- Known to have contraindications to TXA treatment (including allergy to TXA or its excipients, renal impairment, active thromboembolic disease, history of venous or arterial thrombosis, history of convulsion.)
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT06519422 · WOMAN-3