Concealment mechanism {16b}
The IT expert will send the randomisation list to the clinical trial supplies company so that blinded treatment packs can be prepared. The company will produce, label and package tranexamic acid and placebo ampoules into patient treatment packs as per the randomisation list. Tranexamic acid and placebo ampoules will look identical. The trial staff (coordinating centres and sites) will not have access to the randomisation list until after the final database lock.