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• W2113128156 abstract "We thank Male et al. 1.Male C. O'Brien S. Rodriguez V. Mitchell L.G. Central venous catheter‐related thrombosis and thromboprophylaxis in children: a systematic review and meta‐analysis: discussion.J Thromb Haemost. 2015; https://doi.org/10.1111/jth.12818Abstract Full Text Full Text PDF Scopus (3) Google Scholar for their comments, and we agree with many of the points that they raise. We would also like to reiterate our support for much of the original review by Vidal et al. 2.Vidal E. Sharathkumar A. Glover J. Faustino V. Central venous catheter‐related thrombosis and thromboprophylaxis in children: a systematic review and meta‐analysis.J Thromb Haemost. 2014; 12: 1096-109Abstract Full Text Full Text PDF PubMed Scopus (93) Google Scholar. As stated in our previous letter, our concerns were about the strength and singular focus of their conclusions. There is no doubt that clinical trials constitute the gold standard method to determine best treatments. Almost every review in the last 25 years related to thrombosis/anticoagulation in children has concluded that there is an urgent need for randomized controlled trials (RCTs) to improve the levels of evidence. However, despite all our best efforts, no one (including ourselves) has successfully completed an RCT of either prophylaxis or treatment for deep vein thrombosis (DVT) in children that achieved enrollment numbers that either met planned targets or provided statistical certainty about outcome 3.Massicotte P. Julian J. Gent M. Shields K. Marzinotto V. Szechtman B. Andrew M. An open‐label randomized controlled trial of low molecular weight heparin compared to heparin and coumadin for the treatment of venous thromboembolic events in children: the REVIVE trial.Thromb Res. 2003; 109: 85-92Abstract Full Text Full Text PDF PubMed Scopus (158) Google Scholar, 4.Massicotte P. Julian J. Gent M. Shields K. Marzinotto V. Szechtman B. Chan A. Andrew M. An open‐label randomized controlled trial of low molecular weight heparin for the prevention of central venous line‐related thrombotic complications in children: the PROTEKT trial.Thromb Res. 2003; 109: 101-8Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar, 5.Monagle P. Cochrane A. McCrindle B. Benson L. Williams W. Andrew M. Thromboembolic complications after Fontan procedures – the role of prophylactic anticoagulation.J Thorac Cardiovasc Surg. 1998; 115: 493-8Abstract Full Text Full Text PDF PubMed Scopus (139) Google Scholar. Many continue to argue that the next RCT will be successful and that we should push on with the same strategy, despite the fact that RCTs have not given pediatric clinicians in this field satisfactory answers after almost 20 years. For this reason, we maintain our view that we need to think differently and explore alternative approaches to obtain the information needed to best inform clinical practice. One could argue that the only RCTs to date that have specifically investigated central venous line (CVL)‐related DVT prophylaxis in children (Protekt and, to an extent, PARKAA) 4.Massicotte P. Julian J. Gent M. Shields K. Marzinotto V. Szechtman B. Chan A. Andrew M. An open‐label randomized controlled trial of low molecular weight heparin for the prevention of central venous line‐related thrombotic complications in children: the PROTEKT trial.Thromb Res. 2003; 109: 101-8Abstract Full Text Full Text PDF PubMed Scopus (192) Google Scholar, 6.Mitchell L. A prospective cohort study determining the prevalence of thrombotic events in children with acute lymphoblastic leukemia and a central venous line who are treated with L‐asparaginase.Cancer. 2003; 97: 508-16Crossref PubMed Scopus (237) Google Scholar both failed to find a benefit from prophylaxis (not withstanding their underpowered capacity to answer the primary question). So, again, we would question the gestalt that more trials of prophylaxis are necessarily the only way forward to reduce thrombotic complications for children with CVLs. The population of children who require CVLs is indeed very heterogeneous: in their age, underlying conditions, rationale for and duration of central venous access, and therapies received via that central access, not to mention variations in operative and postinsertion care techniques. All of these variables can be confounding factors in multicenter trials, when the enrollment numbers are not sufficiently large. The background noise has been hard to reduce. There remain issues with optimal diagnostic strategies for CVL‐related thrombosis in both clinical trials and clinical practice. Much information could be gained through cross‐sectional studies and carefully documented prospective cohort studies that would assist in identifying higher‐risk practices and patients, and provide improved diagnostic certainty. In theory, a sufficiently large RCT could answer much of this, but, to date, such trials have not been feasible. We fail to see any major change in the world that will suddenly enhance this feasibility. To the best of our knowledge, all current trials of novel anticoagulants in children are struggling with recruitment issues. This is not because of lack of intent by investigators, but is a result of the harsh reality of conducting RCTs in this most complex and difficult patient population. We agree that there are risks of symptomatic and asymptomatic thrombosis in children, although the degree of risk and predictors of poor outcome remain poorly delineated. Furthermore, the risks of anticoagulant treatment are real, whether those treatments are administered in prophylactic or therapeutic doses 7.Monagle P. Studdert D. Newall F. Infant deaths due to heparin overdose: time for a concerted action on prevention.J Paediatr Child Health. 2012; 48: 380-1Crossref PubMed Scopus (12) Google Scholar, and we may not fully know all of the risks 8.Katrancioglu N. Karahan P. Kilic A. Altun A. Katrancioglu O. Polat Z. Comparison of the antiangiogenic effects of heparin sodium, enoxaparin sodium, and tinzaparin sodium by using chorioallantoic membrane assay.Blood Coagul Fibrinolysis. 2012; 23: 218-21Crossref PubMed Scopus (11) Google Scholar. A critical aspect of any treatment decision is weighing up the risk/benefit ratio. Without knowledge of the natural history of the disease, the risk/benefit ratio is impossible to assess. This is especially the case for long‐term risks such as post‐thrombotic syndrome, arguably more so than for acute risks. Again, although we agree that a sufficiently large RCT could potentially answer questions of natural history and long‐term outcome, a more cost‐effective and feasible way to address these questions may be through observational studies. We seek to encourage clinicians to utilize the available resources, networks and collaborations to contribute high‐quality and useful data to support the field, rather than automatically assuming that another RCT (potentially prolonged, underpowered, and ultimately failing) is the only answer. Considering the evidence, we stand by the view that alternative trial designs need to be considered to address questions of prevalence, natural history, diagnostic strategies, and clinical impact. The completion of such alternative trial designs will enable the future conduct of well‐designed feasible clinical trials targeted to at‐risk populations. The net result of this approach will be the generation of robust evidence that will truly advance our field. The authors state that they have no conflict of interest." @default.
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