TY - JOUR
T1 - NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): Evaluation of a national guideline on management of neonatal catheter-related thrombosis
T2 - evaluation of a national guideline on management of neonatal catheter-related venous thrombosis
AU - van Ommen, C. Heleen
AU - Bergman, Klasien A.
AU - Boerma, Marit
AU - Bouma, Heleen A.
AU - Donker, Albertine E.
AU - Gouvernante, Melissa
AU - Hulzebos, Christian V.
AU - Khandour, Dalila
AU - Knol, Ronny
AU - Raets, Marlou A.
AU - Liem, K. Djien
AU - van Lingen, Richard A.
AU - van de Loo, Moniek
AU - Lopriore, Enrico
AU - van der Putten, Mayke
AU - Sol, Jeanine J.
AU - Suijker, Monique H.
AU - Vijlbrief, Daniel C.
AU - Visser, Remco
AU - van Weissenbruch, Mirjam M.
AU - van der Hoeven, Mark A. H. B. M.
AU - Hulzebos, Christiaan V.
AU - Veening, Margreet A.
N1 - Funding Information: The authors thank Prof Dr Anthony Chan from McMaster University, Hamilton, Canada, for his valuable contribution to the development of the national management guideline for neonatal catheter-related venous thrombosis. All authors contributed to the study concept and design, analysis and/or interpretation of data, and writing or critical revision of the manuscript. All authors approved the final version of the manuscript for publication. C.H.v.O. reports consulting fees paid to the department from Bayer BV, Boehringer Ingelheim, and Daiichi Sankyo; lecture honoraria paid to the department from Boehringer Ingelheim; and an unrestricted grant paid to the department from Octapharma, all outside the submitted work. Publisher Copyright: © 2022 International Society on Thrombosis and Haemostasis
PY - 2023/4/1
Y1 - 2023/4/1
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 - anticoagulation
KW - catheter
KW - neonate
KW - thrombolysis
KW - venous thromboembolism
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85042400149&origin=inward
UR - https://www.ncbi.nlm.nih.gov/pubmed/29475450
U2 - 10.1186/s12887-018-1000-7
DO - 10.1186/s12887-018-1000-7
M3 - Article
C2 - 29475450
SN - 1471-2431
VL - 18
SP - 963
EP - 974
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 4
M1 - 84
ER -