Abstract:
BACKGROUND:In critically ill (preterm) neonates, central venous catheters (CVCs) are increasingly used for administration of medication or parenteral nutrition. A serious complication, however, is the development of catheter-related thrombosis (CVC-thrombosis), which may resolve by itself or cause severe complications. Due to lack of evidence, management of neonatal CVC-thrombosis varies among neonatal intensive care units (NICUs). In the Netherlands an expert-based national management guideline has been developed which is implemented in all 10 NICUs in 2014. METHODS:The NEOCLOT study is a multicentre prospective observational cohort study, including 150 preterm and term infants (0-6 months) admitted to one of the 10 NICUs, developing CVC-thrombosis. Patient characteristics, thrombosis characteristics, risk factors, treatment strategies and outcome measures will be collected in a web-based database. Management of CVC-thrombosis will be performed as recommended in the protocol. Violations of the protocol will be noted. Primary outcome measures are a composite efficacy outcome consisting of death due to CVC-thrombosis and recurrent thrombosis, and a safety outcome consisting of the incidence of major bleedings during therapy. Secondary outcomes include individual components of primary efficacy outcome, clinically relevant non-major and minor bleedings and the frequency of risk factors, protocol variations, residual thrombosis and post thrombotic syndrome. DISCUSSION:The NEOCLOT study will evaluate the efficacy and safety of the new, national, neonatal CVC-thrombosis guideline. Furthermore, risk factors as well as long-term consequences of CVC-thrombosis will be analysed. TRIAL REGISTRATION:Trial registration: Nederlands Trial Register NTR4336 . Registered 24 December 2013.
journal_name
BMC Pediatrjournal_title
BMC pediatricsauthors
Sol JJ,van de Loo M,Boerma M,Bergman KA,Donker AE,van der Hoeven MAHBM,Hulzebos CV,Knol R,Djien Liem K,van Lingen RA,Lopriore E,Suijker MH,Vijlbrief DC,Visser R,Veening MA,van Weissenbruch MM,van Ommen CHdoi
10.1186/s12887-018-1000-7subject
Has Abstractpub_date
2018-02-23 00:00:00pages
84issue
1issn
1471-2431pii
10.1186/s12887-018-1000-7journal_volume
18pub_type
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