TY - JOUR
T1 - NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT)
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
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
Y1 - 2023/4
N2 - BACKGROUND: In critically ill (preterm) neonates, catheter-related venous thromboembolism (CVTE) can be a life-threatening complication. Evidence on optimal management in the literature is lacking. In the Netherlands, a consensus-based national management guideline was developed to create uniform CVTE management.OBJECTIVES: To evaluate the efficacy and safety of the national guideline.METHODS: This prospective, multicenter, observational study included all infants aged ≤6 months with CVTE in the Netherlands between 2014 and 2019. CVTE was divided into thrombosis in veins and that in the right atrium, with their own treatment algorithms. The primary outcomes were recurrent venous thrombotic events (VTEs) and/or death due to CVTE as well as major bleeding.RESULTS: Overall, 115 neonates were included (62% male; 79% preterm). The estimated incidence of CVTE was 4.0 per 1000 neonatal intensive care unit admissions. Recurrent thrombosis occurred in 2 (1.7%) infants and death due to CVTE in 1 (0.9%) infant. Major bleeding developed in 9 (7.8%) infants: 2 of 7 (29%) on recombinant tissue plasminogen activator, which was given for high-risk right-atrium thrombosis, and 7 of 63 (11%) on low-molecular-weight heparin (LMWH). Five of the 7 bleedings because of LMWH were complications of subcutaneous catheter use for LMWH administration.CONCLUSION: The management of neonatal CVTE according to the Dutch CVTE management guideline led to a low incidence of recurrent VTEs and death due to VTEs. Major bleeding occurred in 7.8% of the infants. Specific guideline adjustments may improve efficacy and, especially, safety of CVTE management in neonates.
AB - BACKGROUND: In critically ill (preterm) neonates, catheter-related venous thromboembolism (CVTE) can be a life-threatening complication. Evidence on optimal management in the literature is lacking. In the Netherlands, a consensus-based national management guideline was developed to create uniform CVTE management.OBJECTIVES: To evaluate the efficacy and safety of the national guideline.METHODS: This prospective, multicenter, observational study included all infants aged ≤6 months with CVTE in the Netherlands between 2014 and 2019. CVTE was divided into thrombosis in veins and that in the right atrium, with their own treatment algorithms. The primary outcomes were recurrent venous thrombotic events (VTEs) and/or death due to CVTE as well as major bleeding.RESULTS: Overall, 115 neonates were included (62% male; 79% preterm). The estimated incidence of CVTE was 4.0 per 1000 neonatal intensive care unit admissions. Recurrent thrombosis occurred in 2 (1.7%) infants and death due to CVTE in 1 (0.9%) infant. Major bleeding developed in 9 (7.8%) infants: 2 of 7 (29%) on recombinant tissue plasminogen activator, which was given for high-risk right-atrium thrombosis, and 7 of 63 (11%) on low-molecular-weight heparin (LMWH). Five of the 7 bleedings because of LMWH were complications of subcutaneous catheter use for LMWH administration.CONCLUSION: The management of neonatal CVTE according to the Dutch CVTE management guideline led to a low incidence of recurrent VTEs and death due to VTEs. Major bleeding occurred in 7.8% of the infants. Specific guideline adjustments may improve efficacy and, especially, safety of CVTE management in neonates.
KW - anticoagulation
KW - catheter
KW - neonate
KW - thrombolysis
KW - venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85150835571&partnerID=8YFLogxK
U2 - 10.1016/j.jtha.2022.11.044
DO - 10.1016/j.jtha.2022.11.044
M3 - Article
C2 - 36696213
SN - 1538-7933
VL - 21
SP - 963
EP - 974
JO - Journal of thrombosis and haemostasis : JTH
JF - Journal of thrombosis and haemostasis : JTH
IS - 4
ER -