JMIR Publications

ABSTRACT

Background:

Trauma-induced coagulopathy (TIC) is a common and potentially life-threatening coagulopathy as a result of traumatic injury, characterised by abnormal blood clotting and bleeding. Although several treatments have been proposed for TIC, their effectiveness and safety remain unclear. Further, while numerous systematic reviews and meta-analyses on trauma have been conducted, to our knowledge, there is no systematic review and meta-analysis that specifically focuses on management for TIC. Therefore, a comprehensive synthesis of the available evidence on interventions for TIC is needed.

Objective:

This systematic review and meta-analysis aimed to evaluate the effectiveness and safety of interventions for the management of TIC.

Methods:

We will conduct a systematic review and meta-analysis of randomised, non-randomised controlled trials, and observational studies regarding on severe trauma patients with TIC. The interventions will include administration of coagulation factor concentrates, tranexamic acid, and blood component products. The control group will be managed with ordinal transfusion or administered placebo. The primary outcome will be in-hospital mortality. We will search the electronic databases of MEDLINE (PubMed), Web of Science, and the Cochrane Central Register of Controlled Trials. Two reviewers will independently screen the titles and abstracts, retrieve the full text of the selected articles, and extract essential data. We will apply uniform criteria for evaluating the risk of bias associated with individual randomised controlled trials and nonrandomised trials based on the Cochrane risk-of-bias tool. Risk ratio values will be expressed as point estimates with 95% confidence intervals (CIs). Continuous variables will be expressed as the mean difference along with their 95% CIs and P values. We will assess the strength of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach. This review will be the first systematic review and meta-analysis providing information on the effectiveness and safety of interventions for the management of TIC, including administration of coagulation factor concentrates, tranexamic acid, and blood component products. Approval from the ethics board and patient consent are not required for this study protocol.

Results:

We will summarize the selection of the eligible studies using a PRISMA flowchart. The results will be presented in a table of summary of the evidence. The results of the meta-analysis will be depicted using figures and forest plots.

Conclusions:

This systematic review will provide updated information on the efficacy and safety of using coagulation factor concentrates, tranexamic acid, and blood component products for patients with TIC. To our knowledge, there is no systematic review and meta-analysis that specifically focuses on treatments for TIC. Clinical Trial: This study protocol was registered through a protocol registry. The registry number was UMIN000050170.