Impact of a prehospital discrimination between trauma patients with or without early acute coagulopathy of trauma and the need for damage control resuscitation: rationale and design of a multicenter randomized phase II trial

Abstract

Background: The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated. The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for damage control resuscitation.

Methods: The trial will be designed as randomized phase II clinical trial with comparison of the experimental protocol against the standard of care. The TICCS will be calculated on the site of injury for the patients of the intervention group and treatment will be guided by the TICCS value. Seven days mortality, 30 days mortality, global use of blood products and global hospital length-of-stay will be compared.

Discussion: Many data suggest that a very early flagging of trauma patients in need for DCR would be beneficial but this need to be proved. Do we improve our quality of care by an earlier diagnosis? Does a prehospital discrimination between trauma patients with or without a potential need for DCR has a positive impact?

Keywords:

• Trauma
• prehospital medicine
• hemorrhagic shock
• acute care surgery
• blood products transfusion

Ethics approval and consent to participate

The study protocol has been submitted to and approved by the Ethics Committee of each participating center (the Comité d’éthique hospitalo-facultaire universitaire de Liège was designated as the central committee). Due to the nature of the critical and urgent condition of the patients, a third party consent to participate to the study will be first collected. As soon as the patient’s condition will allow a individual a posteriori consent, it will be collected to.

Consent for publication: Consent for publication will be obtained from all participants.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

Elaboration and maintenance of the trial website are funded by the University Hospital of Liège (hospital fund for the promotion of scientific research).