Clinical trial NCT06519422: Tranexamic Acid for Anaemia Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Anemia
Keywords: Tranexamic acid
Antifibrinolytic
Anaemia
Menstrual health
Menstruation
Bleeding
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: The Jon Moulton Charity Trust
First posted: 2024-07-25
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.)

Exclusion Criteria:

* 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.)

Primary outcomes:
measure: Anaemia
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
Secondary outcomes:
measure: Haemoglobin (Hb) concentration
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Severity of anaemia
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Ferritin
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Iron deficiency
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: C-reactive protein (CRP)
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Iron-deficiency anaemia
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Menstrual blood loss
timeFrame: During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)
measure: Perceived change in menstrual blood loss
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Degree of effect of menstrual bleeding on health-related Quality of Life
timeFrame: After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.
measure: Flooding
timeFrame: During 3 menstrual periods (on average about 3 months, but no longer than 6 months from baseline)
Other outcomes:
Locations:
Study officials:
affiliation: London School of Hygiene and Tropical Medicine (Clinical Trials Unit)
name: Dr Sima Berendes
role: STUDY_DIRECTOR
References: