Intraventricular Haemorrhage Clinical Trial
Official title:
Prediction of Major Bleeding in Extremely Low Birth Weight Infants (<1000g) by Sequential Coagulation Monitoring
Up to now, only data about early and single coagulation screening exist in extreme low birth weight infants (ELBW) infants. In neonatal practice, coagulation abnormality in preterm babies is primarily investigated by measuring prothrombin time (PT). In fact, FVII activity, which is an important determinant of PT, is strongly associated with bleeding risk. Thus, a method to measure PT with small volume samples (10μL) provides the possibility for serial monitoring even in ELBW infants (CoaguChek®XS, Roche Diagnostics, Vienna, Austria)). Substitution of fesh frozen plasma seemed beneficial in ELBW infants and first trials with rFVII revealed promising results in this patient population. Thus, coagulation monitoring might lead to early and adequate therapy and therefore to a better outcome. The investigators hypothesize that ELBW infants (<1000g birth weight) with primary severe prolongation of prothrombin time or development of severe prothrombin prolongation during sequential monitoring may have more frequent and more severe bleeding incidents (Intraventricular haemorrhage and pulmonary haemorrhage). The investigators aim to explore whether monitoring of PT can predict bleeding events in ELBW children.
It was recently reported that "early", i.e. in the first 48h of life, coagulation screening
may identify infants at risk of severe IVH. Unfortunately, in the past screening for
coagulation abnormalities and correction of haemostatic defects by prothrombin complex
concentrate, cryoprecipitate or platelet concentrates) and fresh frozen plasma (FFP) had
limited effects in preterm infants. This could have been due to the short duration of
action, incomplete restoration of coagulation or the water and osmotic load associated with
FFP administration. However recently, using a coagulopathy screening strategy (one blood
sample within the first 2h after birth) and substitution with FFP decreased the risk of
developing IVH in infants born at 23 to 26 weeks of gestation. Recombinant Factor VII
(rFVII) provides a new therapeutic option to overcome FFP associated side effects. Small
trials, including infants with pulmonary hemorrhage, showed the safety and effectiveness of
rFVII in VLBW infants; however no randomised controlled trials have been published so far.
As outlined above, bleeding complications are still a major problem in extremely low birth
weight (ELBW) infants and coagulation abnormalities are associated with bleeding. Up to now,
only data about early and single screening exist and coagulation monitoring with multiple
blood sampling was not applied.
In neonatal practice, coagulation abnormality in preterm babies is primarily investigated by
measuring prothrombin time (PT). In fact, FVII activity, which is an important determinant
of PT, is strongly associated with bleeding risk. Thus, a method to measure PT with small
volume samples (10μL) provides the possibility for serial monitoring even in ELBW infants.
Substitution of FFP seemed beneficial in ELBW infants and first trials with rFVII revealed
promising results in this patient population. Thus, coagulation monitoring might lead to
early and adequate therapy and therefore to better outcome.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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