PMID- 29475450 OWN - NLM STAT- MEDLINE DCOM- 20180810 LR - 20181113 IS - 1471-2431 (Electronic) IS - 1471-2431 (Linking) VI - 18 IP - 1 DP - 2018 Feb 23 TI - NEOnatal Central-venous Line Observational study on Thrombosis (NEOCLOT): evaluation of a national guideline on management of neonatal catheter-related thrombosis. PG - 84 LID - 10.1186/s12887-018-1000-7 [doi] LID - 84 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. TRIAL REGISTRATION: Trial registration: Nederlands Trial Register NTR4336 . Registered 24 December 2013. FAU - Sol, Jeanine J AU - Sol JJ AD - Department of Pediatrics, Groene Hart Hospital, Gouda, the Netherlands. AD - Neonatal Intensive Care Unit, Sophia Children's Hospital Erasmus MC, Rotterdam, the Netherlands. FAU - van de Loo, Moniek AU - van de Loo M AD - Neonatal Intensive Care Unit, Emma Children's Hospital AMC, Amsterdam, the Netherlands. FAU - Boerma, Marit AU - Boerma M AD - Department of Pediatric Hematology, Sophia Children's Hospital Erasmus MC, Postbus 2060, 3015 CN, Rotterdam, the Netherlands. FAU - Bergman, Klasien A AU - Bergman KA AD - Neonatal Intensive Care Unit, Beatrix Children's Hospital UMCG, Groningen, the Netherlands. FAU - Donker, Albertine E AU - Donker AE AD - Department of Pediatric Hematology, Maxima Medisch Centrum, Veldhoven, the Netherlands. FAU - van der Hoeven, Mark A H B M AU - van der Hoeven MAHBM AD - Neonatal Intensive Care Unit, MUMC, Maastricht, the Netherlands. FAU - Hulzebos, Christiaan V AU - Hulzebos CV AD - Neonatal Intensive Care Unit, Neonatal Intensive Care Unit, Beatrix Children's Hospital UMCG, Groningen, the Netherlands. FAU - Knol, Ronny AU - Knol R AD - Neonatal Intensive Care Unit, Sophia Children's Hospital Erasmus MC, Rotterdam, the Netherlands. FAU - Djien Liem, K AU - Djien Liem K AD - Neonatal Intensive Care Unit, Amalia Children's Hospital Radboud UMC, Nijmegen, the Netherlands. FAU - van Lingen, Richard A AU - van Lingen RA AD - Neonatal Intensive Care Unit, Isala Clinics, Zwolle, the Netherlands. FAU - Lopriore, Enrico AU - Lopriore E AD - Neonatal Intensive Care Unit, Willem-Alexander Hospital LUMC, Leiden, the Netherlands. FAU - Suijker, Monique H AU - Suijker MH AD - Department of Pediatric Hematology, Emma Children's Hospital AMC, Amsterdam, the Netherlands. FAU - Vijlbrief, Daniel C AU - Vijlbrief DC AD - Neonatal Intensive Care Unit, Wilhelmina Children's Hospital UMCU, Utrecht, the Netherlands. FAU - Visser, Remco AU - Visser R AD - Neonatal Intensive Care Unit, Willem-Alexander Hospital LUMC, Leiden, the Netherlands. FAU - Veening, Margreet A AU - Veening MA AD - Department of Pediatric Hematology, VUMC, Amsterdam, the Netherlands. FAU - van Weissenbruch, Mirjam M AU - van Weissenbruch MM AD - Neonatal Intensive Care Unit, VUMC, Amsterdam, the Netherlands. FAU - van Ommen, C Heleen AU - van Ommen CH AD - Department of Pediatric Hematology, Sophia Children's Hospital Erasmus MC, Postbus 2060, 3015 CN, Rotterdam, the Netherlands. C.vanommen@erasmusmc.nl. LA - eng SI - NTR/NTR4336 GR - Unrestricted grant/Daiichi Sankyo Company/International PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20180223 PL - England TA - BMC Pediatr JT - BMC pediatrics JID - 100967804 SB - IM MH - Catheterization, Central Venous/*adverse effects MH - Clinical Protocols MH - Combined Modality Therapy MH - Female MH - Follow-Up Studies MH - Guideline Adherence MH - Humans MH - Infant MH - Infant, Newborn MH - Male MH - Netherlands MH - Practice Guidelines as Topic MH - Prospective Studies MH - Risk Factors MH - Thrombosis/diagnosis/etiology/*therapy PMC - PMC5824541 OTO - NOTNLM OT - Antithrombotic therapy OT - Catheter OT - Neonate OT - Observational OT - Thrombosis COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: The Medical Ethics Review Committee confirmed that official approval of this study was not required as the Medical Research Involving Human Subjects Act did not apply to the NEOCLOT study. (#14.17.0121) Consent to participate was not required. CONSENT FOR PUBLICATION: Not applicable. COMPETING INTERESTS: This trial is partly funded by an unrestricted grant of Daiichi Sankyo. Daiichi Sankyo has no role in the design of the study and the collection, analysis and interpretation of data, and in writing the manuscript. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/02/25 06:00 MHDA- 2018/08/11 06:00 PMCR- 2018/02/23 CRDT- 2018/02/25 06:00 PHST- 2016/12/14 00:00 [received] PHST- 2018/01/21 00:00 [accepted] PHST- 2018/02/25 06:00 [entrez] PHST- 2018/02/25 06:00 [pubmed] PHST- 2018/08/11 06:00 [medline] PHST- 2018/02/23 00:00 [pmc-release] AID - 10.1186/s12887-018-1000-7 [pii] AID - 1000 [pii] AID - 10.1186/s12887-018-1000-7 [doi] PST - epublish SO - BMC Pediatr. 2018 Feb 23;18(1):84. doi: 10.1186/s12887-018-1000-7.