Dabigatran Presence in Breast Milk (DALMATION)
Research type
Research Study
Full title
An Open Label, Non-Randomised, Phase II study to Determine if Dabigatran and its Metabolites are Detectable in Breast Milk Following Oral Administration to Non-Breastfeeding Mothers
IRAS ID
161412
Contact name
PAUL AYUK
Contact email
Eudract number
2014-004249-29
Duration of Study in the UK
1 years, months, 29 days
Research summary
Women who have given birth are at an increased risk of getting blood clots (deep vein thrombosis). This risk is even higher for women who have had a Caesarean section. Currently these women are given heparin (blood thinning) injections, which they need to take for up to 7 days after delivery. Heparin is safe for the baby as it does not pass into breast milk. Most women are discharged before 7 days after delivery and need to continue doing the injections themselves at home. This involves taking the sharps home, and many women find it difficult and inconvenient. There is evidence to suggest that many women do not take the injections at all.
Dabigatran is a blood thinning drug that is already used in the NHS and is swallowed as a hard capsule. It is licenced in the UK for other indications including the prevention of blood clots after hip/knee replacement surgery. This study aims to find out if the dabigatran capsule could be used instead of heparin injections for these women. First it is necessary to see if the drug is passed into breast milk after it is taken by the mother.
This study aims to approach new mothers who are potentially eligible no sooner than 2 days after delivery of their baby. These mothers will have had a natural birth but still be in the hospital, and have already made an informed decision to exclusively formula feed their baby. Once consent has been taken, a blood sample will be taken to test for kidney function as part of patient screening. Eligibility will be confirmed and documented in the medical notes when the results have been obtained.
All consented and eligible participants will be asked to swallow two capsules of dabigatran and then provide breast milk and blood samples. These samples will later be tested in the laboratory to see if the drug can be detected.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
15/NE/0331
Date of REC Opinion
30 Oct 2015
REC opinion
Further Information Favourable Opinion