Investigational Medicinial Product (IMP) - IM Woman Trial
Key facts
- Estimated value
- £975,000
- Closing date
- 05 Jan 2022
- Contract starts
- 31 Mar 2022
- Contract ends
- 30 Apr 2025
- Procedure
- Open procedure
- Buyer type
- Education
Description
Manufacturing and packing of IMP for the IM Woman Trial due to commence in March 2023.
A randomised, triple-blind, three-arm, non-inferiority trial to assess the efficacy and safety of intramuscular tranexamic acid compared to intravenous tranexamic acid and placebo in women having vvaginal and caesarean section births.
Three arms include experimental treatment (IM TXA), reference treatment/active control (IV TXA), and placebo control (0.9% sodium chloride solution).
Provision of treatment kit boxes required for 4 campaigns with approximately 10,000 patient packs per campaign. Recruitment period is 24 months - campaign approximately once every 6 months commencing March 2023.
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