April 2015. The trial has randomized in almost 3,000 women and seeks 15,000 in total. Ghana and Pakistan's Ministries of Health have approved the study. Kenya, Jamaica, Nepal, Zambia, UK and Colombia have already joined the study too.
An interesting article looks at the cost-effectiveness of TXA in terms of lives saved in areas with low blood supply and high rates of bloodborne infection
Tranexamic acid or TXA is a systemic antifirbrinolytic agent, which inhibits clot breakdown and stems excessive bleeding. This easily administered medicine has been shown to significantly reduce general morbidity and mortality due to bleeding in trauma patients. TXA has the potential to save women’s live in childbirth by decreasing blood loss due to postpartum hemorrhage. TXA is an off-patent, generic medicine made by several companies and costs about $4.50 per gram. The drug is marketed in tablet form as Lysteda and in IV form as Cyklokapron in the U.S., as Transamin in Asia, and as Espercil in South America.
The clinical trial being conducted by LSHTM will be completed in 2015--if positive, TXA could reduce the need for hysterectomies and for blood transfusions. Read our blog post on the subject. Another article describes the clinical trial in detail. The trial will look to see how TXA affects outcomes including hysterectomy and postpartum hemorrhage.
News about The WOMAN (World Maternal Antifibrinolytic) trial, coordinated by the London School of Hygiene and Tropical Medicine (University of London), has been launched in response to this important clinical uncertainty. WOMAN is a pragmatic, randomised, double blind, placebo controlled trial among women with a clinical diagnosis of postpartum haemorrhage that will determine reliably the effect of the early administration of TXA on death, hysterectomy and other morbidities (surgical interventions, blood transfusion, risk of non-fatal vascular events), in women with PPH. The trial is already recruiting eligible women in hospitals in Africa, Asia and Europe but many new collaborating centres are needed in order to reach the target sample size of 15,000 women.
Full details of the protocol and how to join the trial are available on the trial website (www.thewomantrial.lshtm.ac.uk), or by e-mailing TheWomanTrial@Lshtm.ac.uk. The success of the WOMAN Trial depends on the collaboration of midwives, nurses and doctors from hospitals all around the world. The hope is that by working together we might identify a safe and effective treatment that could save the lives of tens of thousands of new mothers.
