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TeMpOH-1

 

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

 

Go to the TeMpOH-1 website.

 

Rationale
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.

 

Objective
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.

Methods
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).

 

Sample size calculation
The LEMMoN study has reported an incidence of major obstetric haemorrhage of 4.5 per 1000 deliveries in the Netherlands, of which almost 90% occurring during delivery or postpartum(1). With an annual live birth rate of approximately 180.000 we expect to include approximately 1600 women in our study.

(1) Zwart JJ, et al. Severe maternal morbidity during pregnancy, delivery and puerperium in the Netherlands: a nationwide population-based study of 371,000 pregnancies. BJOG 2008; 115(7):842-850.

 

Economic evaluation
Not applicable

 

Time schedule
Data will be collected from April 2013 till April 2014.

 

Projectleader
Mw. Dr. J.G. van der Bom
Clinical epidemiologist, Leiden University Medical Center (LUMC)
Head of Center for Clinical Transfusion Research (Sanquin Research, Leiden)

 

Projectgroup
Mw. Dr. K.W.M. Bloemenkamp, Obstetrics and Gynaecology, LUMC
MW. Dr. J.G. van der Bom, Clinical Epidemiology, LUMC
Mw. Dr. S. le Cessie, Medical Statistics and Clinical Epidemiology, LUMC
Prof. Dr. H.C.J. Eikenboom, Thrombosis and Haemostasis, LUMC
Mw. Drs. D.D.C.A. Henriquez, Obstetrics and Gynaecology, LUMC
Prof. Dr. J.J.M. van Roosmalen, Obstetrics and Gynaecology, LUMC
Mw. Dr. C. So-Osman, Center for Clinical Transfusion Research (Sanquin Research Leiden)
Dr. L.M.G. van de Watering, Center for Clinical Transfusion Research (Sanquin Research Leiden)
Prof. Dr. J.J. Zwaginga, Hematology, LUMC
Dr. J.J. Zwart, Obstetrics and Gynaecology, Deventer Ziekenhuis

 

Contact (researcher)
Mw. Drs. D.D.C.A. Henriquez, resident in Obstetrics & Gynaecology
Center for Clinical Transfusion Research (Sanquin Research Leiden)
Plesmanlaan 1A
2333 BZ Leiden
T: 071-5685126 / 06-17366034
E:
tempoh1@studies-obsgyn.nl