Prediction of Major Bleeding in ELBW-infants (<1000g) by Sequential Coagulation Monitoring

NCT01976013 | Completed

• 1 other identifier: MUV-Coagu
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intraventricular Haemorrhage; Pulmonary Haemorrhage

Keywords

PT; INR; intraventricular haemorrhage; pulmonary haemorrhage; ELBW infants

Outcome Measures

Primary Outcomes (1)

• major bleeding

  pulmonary bleeding, intraventricular hemorrhage

  30 days

Secondary Outcomes (1)

• mortality

  30 days

Study Arms (1)

Coaguchek

OTHER

infants will receive sequential coagulation checks

Device: Coaguchek

Interventions

Coaguchek DEVICE

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.

Coaguchek

Eligibility Criteria

• Age: 2 Minutes - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants with a birth weight \<1000g
• signed informed consent

You may not qualify if:

• Congenital heart disease
• major congenital birth defects

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

• Nadja Haiden, MD

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof.MD

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 5, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: April 5, 2016

Record last verified: 2016-04

Locations

AU (1)