Prediction of Major Bleeding in ELBW-infants (<1000g) by Sequential Coagulation Monitoring
Condition: Intraventricular Haemorrhage; Pulmonary Haemorrhage
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Coaguchek
Intervention type(s): Device
Intervention description(s): The investigators plan to draw 10μL blood (i.e. approximately 1/5000 of the blood volume of an ELBW infant) within the scope of routine blood sampling. Thus, the number of blood samples will be variable. A cumulative sample volume for the whole study period will not exceed 300μL.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: PT; INR; intraventricular haemorrhage; pulmonary haemorrhage; ELBW infants