Effects of early factor XIII replacement in postpartum hae morrhage: study protocol for a multicentre, open-label, randomised, controlled, investigator-initiated trial.

ABSTRACT:

Introduction

The primary objective of this trial is to evaluate the effect of replenishing coagulation factor XIII (FXIII) in women with postpartum haemorrhage (PPH) on measured blood loss (MBL). Based on earlier research, we hypothesise that the administration of FXIII leads to a significant reduction in postpartum blood loss.

Methods and analysis

This is a randomised, controlled trial that will allocate eligible patients in the event of a PPH and after receiving tranexamic acid either to the treatment group, receiving FXIII, or to the control group (standard of care). The primary endpoint is the MBL within 24 hours using a standardised method. For the primary analysis, estimation of the OR under a proportional odds assumption is conducted simultaneously for all possible cu

SUBMITTER: Haslinger C 

PROVIDER: S-EPMC12067823 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature