ArticleResearch and practice in thrombosis and haemostasis2021
Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study.
Article in Research and practice in thrombosis and haemostasis, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 15 citations in OpenAlex.
- Prevalence of abnormal uterine bleeding and quality of life after venous thromboembolism by oral anticoagulant use: the GENB-OAC Study.Research and practice in thrombosis and haemostasis · 2026Article
- Management of abnormal uterine bleeding on anticoagulation: the patient-clinician perspective.Journal of thrombosis and haemostasis : JTH · 2024Review
- Heavy menstrual bleeding on direct factor Xa inhibitors: the MEDEA randomized clinical trial.Research and practice in thrombosis and haemostasis · 2024Article
- Venous thromboembolism among physically active young adult females.Research and practice in thrombosis and haemostasis · 2023Article
- How do anticoagulants impact menstrual bleeding and quality of life? - The PERIOD study.Research and practice in thrombosis and haemostasis · 2023Article
- Anticoagulant therapy for women: implications for menstruation, pregnancy, and lactation.Hematology. American Society of Hematology. Education Program · 2022Article
- Special Considerations for Women of Reproductive Age on Anticoagulation.Journal of general internal medicine · 2022Review
- Reproductive issues in women on direct oral anticoagulants.Research and practice in thrombosis and haemostasis · 2021Article
- Heavy menstrual bleeding on direct factor Xa inhibitors: Rationale and design of the MEDEA study.Research and practice in thrombosis and haemostasis · 2021Article
- Incidence and Impact on Quality of Life of Heavy Menstrual Bleeding in Women on Oral Anticoagulant Therapy.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/HemostasisArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 11 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn premenopausal women, treatment with direct oral factor Xa inhibitors is associated with an increased risk of heavy menstrual bleeding (HMB) compared with vitamin K antagonists (VKA). Treatment with the direct oral thrombin inhibitor dabigatran appears to be associated with a reduced risk of HMB compared with VKA. These findings come from small observational studies or post hoc analyses of trials in which HMB was not a primary outcome. Use of tranexamic acid during the menstrual period may be effective in patients with HMB, but prospective data regarding efficacy and safety in patients on anticoagulant treatment are lacking. RATIONALE AND
designA direct comparison of a factor Xa inhibitor and a thrombin inhibitor with HMB as primary outcome, as well as an evaluation of the effects of adding tranexamic acid in women with anticoagulant-associated HMB is highly relevant for clinical practice. The MEDEA study is a randomized, open-label, pragmatic clinical trial to evaluate management strategies in premenopausal women with HMB associated with factor Xa inhibitor therapy. OUTCOMES: Women using factor Xa inhibitors with proven HMB, as assessed by a pictorial blood loss assessment chart (PBAC) score of >150, will be randomized to one of three study arms: (i) switch to dabigatran; (ii) continue factor Xa inhibitor with addition of tranexamic acid during the menstrual period; or (iii) continue factor Xa inhibitor without intervention. The primary outcome is the difference in PBAC score before and after randomization. Here, we present the rationale and highlight several unique features in the design of the study.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.