We aimed to systematically describe, via a scoping review, the literature reporting strategies for prevention and management of mediastinal bleeding post pediatric cardiopulmonary bypass surgery.
MEDLINE, EMBASE, PubMed, and Cochrane CENTRAL Register.
Two authors independently screened publications from 1980 to 2016 reporting the effect of therapeutic interventions on bleeding-related postoperative outcomes, including mediastinal drain loss, transfusion, chest re-exploration rate, and coagulation variables. Inclusions: less than 18 years, cardiac surgery on cardiopulmonary bypass.
Data from eligible studies were extracted using a standard data collection sheet.
Overall, 299 of 7,434 screened articles were included, with observational studies being almost twice as common (n = 187, 63%) than controlled trials (n = 112, 38%). The most frequently evaluated interventions were antifibrinolytic drugs (75 studies, 25%), blood products (59 studies, 20%), point-of-care testing (47 studies, 16%), and cardiopulmonary bypass circuit modifications (46 studies, 15%). The publication rate for controlled trials remained constant over time (4–6/yr); however, trials were small (median participants, 51; interquartile range, 57) and overwhelmingly single center (98%). Controlled trials originated from 22 countries, with the United States, India, and Germany accounting for 50%. The commonest outcomes were mediastinal blood loss and transfusion requirements; however, these were defined inconsistently (blood loss being reported over nine different time periods). The majority of trials were aimed at bleeding prevention (98%) rather than treatment (10%), nine studies assessed both.
Overall, this review demonstrates small trial sizes, low level of evidence, and marked heterogeneity of reported endpoints in the included studies. The need for more, higher quality studies reporting clinically relevant, comparable outcomes is highlighted. Emerging fields such as the use of coagulation factor concentrates, goal-directed guidelines, and anti-inflammatory therapies appear to be of particular interest. This scoping review can potentially guide future trial design and form the basis for therapy-specific systematic reviews.
1PICU, Evelina London Children’s Hospital, St Thomas’ Hospital, Westminster Bridge Road, London, United Kingdom.
2Department of Haematology, St Thomas’ Hospital, London, United Kingdom.
Dr. Siemens contributed in protocol design, literature search, data collection, wrote first draft. Dr. Sangaran contributed in protocol design, literature search, data collection, and data collation. Dr. Hunt contributed in study concept, protocol design, methodological expertise, and coedited first draft. Dr. Murdoch contributed in study concept, eligibility review (for included articles), and data checking. Dr. Tibby contributed in study concept, project oversight, eligibility review (for included articles), and coedited first draft. All authors have reviewed and approved this final version of the submitted article.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/pccmjournal).
Abstract publication/presentation: ISICEM Brussels 2016.
Dr. Tibby disclosed that he and Drs. Siemens and Hunt are investigators in the FIBCON Trial (ISRCTN: ISRCTN50553029), which is funded by CSL Behring €220,000 (CSL-B advised on aspects of FIBCON trial design but had no role in design, study conduct, data analysis, data presentation), sponsored Guy’s & St Thomas’ National Health Service Foundation Trust. The remaining authors have disclosed that they do not have any potential conflicts of interest.
For information regarding this article, E-mail: firstname.lastname@example.org