Blood Transfusion Clinical Trial
Official title:
Risk Factors, Management and Complications of Severe Post-partum Hemorrhage: A Retrospective Analysis in a Single Tertiary Referral Center
The incidence of severe post-partum hemorrhage has been increasing in developed countries. The reason for this is at least partially unknown. Surgical techniques, holistic treatment protocols and strategies in blood product administration may have changed patient outcome and, for example the incidence of transfusion related side effects. A retrospective analysis of the whole cohort of parturients in 2009-2015 in Tampere University Hospital will be made to assess the risk factors for severe PPH (ie. estimated blood loss more than 1500ml during delivery) and examine the possible change in blood transfusion strategies and its effect on bleeding (for example, implementation of massive transfusion protocol, amount of blood products used, effect of red blood cell:fresh-frozen plasma ratio, use of pharmacological agents for coagulation management, introduction of new angiological and surgical techniques etc.) and complications, laboratory parameters and patient outcome.
Post-partum haemorrhage (PPH) still remains one of leading causes of morbidity in the
obstetric population and a recent report from the United Kingdom revealed that hemorrhage is
the sixth most important direct cause of maternal mortality. During labor, the blood flow in
the uterus increases and obstetric hemorrhage may quickly turn to massive bleeding requiring
massive transfusion of allogeneic blood products. Although introduction of massive
transfusion protocols (MTP) may have improved survival in trauma patients, administration of
allogeneic blood products, although life-saving, is also associated with considerable side
effects. That is why a stepwise progressive approach and implementation of treatment
protocols describing the timely use of different pharmacological agents and surgical or
radiological interventions are called for. Risk factors for blood transfusion (as a surrogate
marker for PPH) at delivery in Finland have been recently studied , and the results seem to
be in consonance with reports from several developed countries, which demonstrate a marked
increase in incidence of PPH. However, the causes for the increase in postpartum hemorrhage
remain at least partly unclear. Also, complication rates of blood transfusion and other
adverse outcomes in the treatment of an obstetric patient with severe bleeding are not very
recently studied (19). Identification of PPH risk factors, change in transfusion strategies
and surgical techniques and implementation of holistic treatment protocols may have had an
effect on the complication rate, costs and total amount of blood product usage and bleeding,
but to investigators' knowledge, these are underreported in current studies.That is why it
seems justified to examine a cohort of parturients with severe PPH under a long time span to
find out whether the change in practice is reflected in patients' outcome.
From 2009 to December 2015, all patients having a marked post-partum hemorrhage (estimated
blood loss 1500ml) will be tracked from Tampere University hospital's computerized perinatal
database (iPana). Approximate number of patients is 900: according to the database, the
incidence of severe PPH in our hospital is 130-160/year. General patient characteristics will
be recorded: age, weight, height, parity, gestational age, previous deliveries and cesarean
sections, chronic diseases, complications and medication during pregnancy. The mode of
delivery, labour characteristics (duration, interval between PROM and delivery,
chorioamnionitis), use of uterotonic agents and diagnoses of obstetric disease will be
recorded (e.g. placental abnormalities). Laboratory parameters during treatment of PPH will
be collected: a baseline aPTT, PT (INR), Fibrinogen concentration, ATIII, Hb, platelet count
and respective (lowest) values during treatment of PPH and blood gas analysis information,
especially lowest base excess and lactate and lowest ca-ion. Other possible factors affecting
hemostasis such as body temperature, hemodynamic parameters during resuscitation and surgical
treatment will be searched from medical records. Total amount of bleeding and allogeneic
blood products, fibrinogen concentrate, prothrombin complex concentrate, FXIII and
recombinant factor VII consumption will be recorded as primary end points. As secondary
endpoints, the number of emergency hysterectomies, intensive care admissions,
transfusion-related side effects and thromboembolic complications will be studied and
recorded up to 30 days after delivery.
The investigators' aim is to identify risk factors for severe PPH (ie. estimated blood loss
more than 1500ml during delivery) and examine the possible change in blood transfusion
strategies and its effect on bleeding (for example, implementation of massive transfusion
protocol, amount of blood products used, effect of red blood cell:fresh-frozen plasma ratio,
use of pharmacological agents for coagulation management, introduction of new angiological
and surgical techniques etc.) and complications, laboratory parameters and patient outcome.
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