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Tranexamic Acid for Anaemia Trial

NCT06519422

RecruitingPhase 3

Sponsor: London School of Hygiene and Tropical Medicine

Conditions: Anaemia

Interventions: Tranexamic Acid 500 MG, Placebo

Countries: Nigeria, Pakistan, Tanzania

Anaemia is when the body does not have enough healthy red blood cells to carry oxygen. It is common in women because they lose blood every month during their periods. Anaemia can womwn make feel tired, weak, dizzy and out of breath. It can also make it harder to study, work or look after their family. If woman become pregnant with anaemia, it can cause problems for both mother and baby, such as early birth or heavy bleeding when giving birth. 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. 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)

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Adult women aged 18 years and older.
* Currently menstruating, with menstrual periods occurring at least every 38 days and lasting ≥2 days.
* Anaemia at screening, defined as hemoglobin (Hb) \<120 g/L by point-of-care finger prick test.
* Willing and able to provide informed consent.
* 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:

* Planning to get pregnant during the trial period
* Already taking TXA
* 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 (3)

Ibadan, Oyo State, Nigeria
Islamabad, Pakistan
Mbeya, Tanzania