Titre :

The effect of tranexamic acid on blood loss in orthognathic surgery: a randomized, placebo-controlled, equivalence study.

Auteur(s) :

Jozefowicz, E. [Auteur]
Sabourdin, N. [Auteur]
Groupe de Recherche Clinique en Anesthésie Réanimation médecine PEriopératoire [GRC 29 - ARPE]
Lambelin, V. [Auteur]
Lejeune, V. [Auteur]
Delassus, R. [Auteur]
Tavernier, Benoit [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Titre de la revue :

International Journal of Oral and Maxillofacial Surgery

Nom court de la revue :

Int J Oral Maxillofac Surg

Numéro :

51

Pagination :

p. 637-642

Date de publication :

2022-05

ISSN :

1399-0020

Mot(s)-clé(s) en anglais :

blood loss surgical
antifibrinolytic agents
therapeutic equivalency
blood transfusion
orthognathic surgical procedure

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Orthognathic surgery can cause substantial bleeding. Recent meta-analyses concluded that there is a statistically significant reduction in perioperative blood loss with the preventive use of tranexamic acid (TA). However, ...
Lire la suite >Orthognathic surgery can cause substantial bleeding. Recent meta-analyses concluded that there is a statistically significant reduction in perioperative blood loss with the preventive use of tranexamic acid (TA). However, the mean reported difference in bleeding was moderate, and the clinical relevance of this blood-sparing effect remains debated. We therefore conducted a prospective, double-blind, randomized, placebo-controlled equivalence study of the effect of TA in patients undergoing Lefort I or bimaxillary osteotomies. Our main outcome measure was total blood loss on postoperative day 1. The equivalence margin was ± 250 ml for the difference in blood loss and its 95% confidence interval. One hundred and forty-seven patients were randomized, of which 122 underwent bimaxillary osteotomies. Blood loss in the treatment group was 682 ± 323 vs. 875 ± 492 ml. The mean difference in bleeding was -132 [-243; -21] ml as per-protocol, but -193 [-329; -57] ml in intention-to-treat: the limits of this confidence interval exceeded the margin of equivalence. Similar results were obtained when analysing only patients undergoing bimaxillary osteotomy. Haemoglobin decreased by 1.8 ± 1.2 g/dl with TA, vs. 2.6 ± 1.1 g/dl with placebo (p<0.001). Our study did not demonstrate equivalence between TA and placebo on perioperative blood loss in orthognathic surgery. TA may reduce blood loss but without evidence of clinical consequences.Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Date de dépôt :

2023-11-15T05:56:46Z
2024-04-19T09:39:45Z