TeMpOH-1 Studie

Transfusion strategies in women during Major Obstetric Haemorrhage (TeMpOH-1)

Major obstetric haemorrhage is the most important cause of severe maternal morbidity. Observational studies on major haemorrhage associated with trauma and surgery have shown an apparent survival advantage with the administration of high cumulative ratios plasma and platelets to red blood cells (RBCs). However, these results may have been confounded due to reverse causation and do not take time-varying treatment and time-dependent confounding into account. Furthermore, some authors recently proposed that not the ratios between the transfused blood components determine the outcome, but rather the timing of transfusion of plasma and platelets. 

To determine the effect of early administration of plasma and platelets alongside RBCs on the clinical course of women with obstetric haemorrhage compared to administration at a later stage in treatment.

Study design
Nationwide, retrospective cohort study

Study population
Women that, during pregnancy, delivery or puerperium, received transfusions of fresh frozen plasma (FFP) and/or platelets alongside RBCs because of obstetric haemorrhage from 1 January 2011 until 1 January 2013 in the Netherlands. Obstetric haemorrhage requiring at least four units of packed red blood cells will be considered major obstetric haemorrhage.

Women that received FFP and/or platelets alongside RBCs due to obstetric haemorrhage will be identified by cross-referencing data from departments of blood transfusion services with data from local birth registers. Data on characteristics of and treatment of selected women will be collected by performing a chart review of patients. The effect of timing of transfusion of FFP and/or platelets in conjunction with RBC transfusion on maternal mortality and severe maternal morbidity will be determined by using an inverse probability weighted Cox proportional hazard model.

Main study endpoints
Maternal mortality and severe maternal morbidity (postpartum hysterectomy, postpartum arterial embolization and/or intensive care unit admission).