Core Outcome Measures in Effectiveness Trials

Strategies for Prevention and Management of Bleeding Following Pediatric Cardiac Surgery on Cardiopulmonary Bypass: A Scoping Review

General Information

Abstract:
OBJECTIVE: 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. DATA SOURCES: MEDLINE, EMBASE, PubMed, and Cochrane CENTRAL Register. STUDY SELECTION: 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 EXTRACTION: Data from eligible studies were extracted using a standard data collection sheet. DATA SYNTHESIS: 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. CONCLUSIONS: 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.

Authors:
Siemens, K. Sangaran, D. P. Hunt, B. J. Murdoch, I. A. Tibby, S. M.

Publication

Journal:
Pediatr Crit Care Med
Volume:
19
Issue:
1
Pages:
40 - 47
Year:
2018
DOI:
Further Study Information

Date:
2016
Funding source(s):

Health Area

Disease Category
Heart & circulation

Disease Name
N/A

Target Population

Age Range
0 - 18

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Literature review

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.


Stakeholders Involved

None

Study Type

Systematic review of outcomes measured in trials

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