Tranexamic Acid for Anaemia Trial
ConditionAnaemia
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLondon School of Hygiene and Tropical Medicine
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.)
Trial design
Design model
Parallel
Treatments tested in this trial
Tranexamic Acid 500 MG
DrugTablets
Placebo
DrugTablets
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
Proportion of Participants with Anaemia
Proportion of participants with hemoglobin (Hb) \<120 g/L, measured via venous blood samples at baseline and at the end of the intervention period.
Time frame
From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.Secondary outcomes
1
Haemoglobin (Hb) concentration
Hb measured on venous blood at baseline and end of treatment/ early withdrawal
Time frame
From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), 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
From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.3
Ferritin
Serum ferritin (from venous blood sample) and CRP-adjusted ferritin (see below, under C-reactive protein) measured at baseline and end of the intervention period; we will report change in iron status from baseline
Time frame
From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), 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); we will report change in iron status from baseline Note: CRP-adjusted ferritin (see below);
Time frame
From enrollment until after the 6th menstrual period but before the 7th, or within 9 months from randomization (±1 week), whichever occurs first.Other outcomes
1
Cost-Effectiveness of Tranexamic Acid vs Placebo for Anemia Treatment
Evaluation of the cost-effectiveness of the trial interventions based on health-related unit costs calculated at the time of the analysis and clinical health outcomes (proportion of participants with anaemia resolved).
Time frame
At the time of analysis, following study completion2
Participant Satisfaction With Primary IMP as Assessed by Likert Scale
Administered at the final clinical follow-up visit using a structured questionnaire question. Evaluation parameters rely on an explicit 5-point Likert scale layout: 1 = Very satisfied, 2 = Satisfied, 3 = Neutral, 4 = Dissatisfied, and 5 = Very dissatisfied. Lower numerical values signify superior levels of overall participant intervention satisfaction.
Time frame
At final visit (after 6th menstrual period or within 9 months from randomization).3
Percentage of Participants Experiencing Pre-specified Adverse Events
Routine surveillance of systemic toxicities and safety outcomes detailed in the protocol, tracking the proportions of participants who develop nausea, vomiting, diarrhea, seizures, or thromboembolic events.
Time frame
From randomisation until 28 days following the final dose of the trial intervention.4
Behavioral Treatment Adherence via Physical Tablet Counts
Measured quantitatively by counting remaining study tablets within returned treatment bottles at in-person follow-up contacts.
Time frame
Throughout the trial from enrollment through the final visit (after 6th menstrual period or within 9 months from randomisation).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
London School of Hygiene and Tropical Medicine
Lead sponsor
University of Dar es Salaam, Tanzania (Mbeya College of Health and Allied Sciences)
Collaborator
Coefficient Giving (Formerly Open Philanthropy)
Collaborator
Versailles Saint-Quentin-en-Yvelines University
Collaborator
Shifa Tameer-e-Millat University
Collaborator
University College Hospital, Ibadan
Collaborator
The Jon Moulton Charity Trust
Collaborator
University of Edinburgh
Collaborator
Source ClinicalTrials.gov