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.


Journal

Acta chirurgica Belgica
ISSN: 0001-5458
Titre abrégé: Acta Chir Belg
Pays: England
ID NLM: 0370571

Informations de publication

Date de publication:
Apr 2019
Historique:
pubmed: 11 5 2018
medline: 5 11 2019
entrez: 11 5 2018
Statut: ppublish

Résumé

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. 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. 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?

Sections du résumé

BACKGROUND 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 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 CONCLUSIONS
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?

Identifiants

pubmed: 29745298
doi: 10.1080/00015458.2018.1470276
doi:

Types de publication

Clinical Trial, Phase II Comparative Study Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

IM

Pagination

88-94

Auteurs

Martin Tonglet (M)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

Vincenzo D'Orio (V)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

Didier Moens (D)

b Centre Médical Héliporté de Bra sur Lienne , Bra sur Lienne , Belgium.

François-Xavier Lens (FX)

c Centre Hospitalier de Jolimont-Lobbes , La Louvière , Belgium.

Jérémy Alves (J)

c Centre Hospitalier de Jolimont-Lobbes , La Louvière , Belgium.

Maximilien Thoma (M)

d Cliniques Universitaires Saint-Luc , Bruxelles , Belgium.

Bernard Kreps (B)

e Centre Hospitalier Universitaire Saint-Pierre , Bruxelles , Belgium.

Pierre Youatou Towo (P)

e Centre Hospitalier Universitaire Saint-Pierre , Bruxelles , Belgium.

Romain Betz (R)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

Justine Piazza (J)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

Julien Szecel (J)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

Gerard Decoster B (G)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

Michèle Guillaume (M)

f Département des Sciences de la Santé Publique, Service Nutrition, Environnement et Santé , Universite de Liege , Liège , Belgium.

Eddy Husson (E)

f Département des Sciences de la Santé Publique, Service Nutrition, Environnement et Santé , Universite de Liege , Liège , Belgium.

Anne Françoise Donneau (AF)

f Département des Sciences de la Santé Publique, Service Nutrition, Environnement et Santé , Universite de Liege , Liège , Belgium.

Jean Louis Poplavsky (JL)

g European Drug Development Consulting , Amay , Belgium.

Jean Marc Minon (JM)

h Centre Hospitalier Regional de la Citadelle , Liège , Belgium.

Alexandre Ghuysen (A)

a Centre Hospitalier Universitaire de Liege , Liège , Belgium.

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Classifications MeSH