Tranexamic Acid for Anaemia Trial
ConditionAnemia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLondon School of Hygiene and Tropical Medicine
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid 500 MG
DrugTablets
Matched placebo
Other interventionMatched placebo tablets (inactive ingredients only, including microcrystalline cellulose, magnesium stearate BP and lactose)
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: Tranexamic acid (TXA)Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Anaemia
The proportion of participants with anaemia, defined as Haemoglobin (Hb) \< 120 g/L (measured on venous blood)
Time frame
After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.Secondary outcomes
1
Haemoglobin (Hb) concentration
Hb measured on venous blood
Time frame
After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.2
Severity of anaemia
Mild Anaemia (Hb=110-119 g/L); Moderate Anaemia (Hb=80-109 g/L); Severe Anaemia (Hb \< 80 g/L); Hb measured on venous blood
Time frame
After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.3
Ferritin
Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein)
Time frame
After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.4
Iron deficiency
Iron deficiency defined as ferritin \<15 ug/L (WHO definition) and defined as ferritin \<30 ug/L, (new clinical consensus); Serum ferritin from venous blood sample; CRP-adjusted ferritin (see below, under C-reactive protein) Note: CRP-adjusted ferritin (see below)
Time frame
After the 3rd and before the 4th menstrual period or by 6 months from baseline, whichever occurs first.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
London School of Hygiene and Tropical Medicine
Lead sponsor
The Jon Moulton Charity Trust
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: