TY - JOUR
T1 - NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): evaluation of a national guideline on management of neonatal catheter-related thrombosis
AU - Sol, Jeanine J.
AU - van de Loo, Moniek
AU - Boerma, Marit
AU - Bergman, Klasien A.
AU - Donker, Albertine E.
AU - van der Hoeven, Mark A. H. B. M.
AU - Hulzebos, Christiaan V.
AU - Knol, Ronny
AU - Liem, K. Djien
AU - van Lingen, Richard A.
AU - Lopriore, Enrico
AU - Suijker, Monique H.
AU - Vijlbrief, Daniel C.
AU - Visser, Remco
AU - Veening, Margreet A.
AU - van Weissenbruch, Mirjam M.
AU - van Ommen, C. Heleen
PY - 2018/2/23
Y1 - 2018/2/23
N2 - 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.
AB - 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.
KW - Neonate
KW - Catheter
KW - Thrombosis
KW - Antithrombotic therapy
KW - Observational
KW - CLINICAL-PRACTICE GUIDELINES
KW - ED AMERICAN-COLLEGE
KW - ANTITHROMBOTIC THERAPY
KW - CHILDREN
KW - INFANTS
KW - ENOXAPARIN
KW - HEMOSTASIS
KW - PREVENTION
KW - NEWBORNS
KW - EMBOLISM
U2 - 10.1186/s12887-018-1000-7
DO - 10.1186/s12887-018-1000-7
M3 - Article
SN - 1471-2431
VL - 18
JO - Bmc Pediatrics
JF - Bmc Pediatrics
IS - 1
M1 - 84
ER -