Tranexamic acid for anaemia trial

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

Registry ID
ISRCTN94981477
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE3
Study type
INTERVENTIONAL
Sponsor
London School of Hygiene & Tropical Medicine
Enrollment
4000
Start date
2026-08-10
Completion date
2028-09-30
Last update
2026-08-17

Conditions

Summary

Anaemia

Detailed description

Participants are randomised using blocked randomisation to: Experimental: Tranexamic acid (TXA) 1 g (two 500 mg tablets) orally, three times daily, from the first to the last day of menstruation for up to 5 days, during 6 successive menstrual periods. Placebo: Matched placebo tablets orally, three times daily, from the first to the last day of menstruation for up to 5 days, during 6 successive menstrual periods

Interventions

Inclusion criteria

1. Adult women aged 18 years and older. 2. Currently menstruating, with menstrual periods occurring at least every 38 days and lasting ≥2 days. 3. Anaemia at screening, defined as hemoglobin (Hb) <120 g/L by point-of-care finger prick test. 4. Willing and able to provide informed consent. 5. Able to attend in-person follow-up visits during the trial period. Individuals with known thalassaemia and sickle cell disease are eligible to participate and take the trial treatment but will not be given standard of care iron supplementation unless it is prescribed by their own treating clinician. They will continue to receive their usual standard care.

Exclusion criteria

1. Planning to get pregnant during the trial period 2. Already taking TXA 3. Known to have possible 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)

Locations

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