Prehospital Tranexamic Acid for Severe Trauma.
Journal
The New England journal of medicine
ISSN: 1533-4406
Titre abrégé: N Engl J Med
Pays: United States
ID NLM: 0255562
Informations de publication
Date de publication:
13 Jul 2023
13 Jul 2023
Historique:
medline:
14
7
2023
pubmed:
14
6
2023
entrez:
14
6
2023
Statut:
ppublish
Résumé
Whether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain. We randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury. A total of 1310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups. Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).
Sections du résumé
BACKGROUND
BACKGROUND
Whether prehospital administration of tranexamic acid increases the likelihood of survival with a favorable functional outcome among patients with major trauma and suspected trauma-induced coagulopathy who are being treated in advanced trauma systems is uncertain.
METHODS
METHODS
We randomly assigned adults with major trauma who were at risk for trauma-induced coagulopathy to receive tranexamic acid (administered intravenously as a bolus dose of 1 g before hospital admission, followed by a 1-g infusion over a period of 8 hours after arrival at the hospital) or matched placebo. The primary outcome was survival with a favorable functional outcome at 6 months after injury, as assessed with the use of the Glasgow Outcome Scale-Extended (GOS-E). Levels on the GOS-E range from 1 (death) to 8 ("upper good recovery" [no injury-related problems]). We defined survival with a favorable functional outcome as a GOS-E level of 5 ("lower moderate disability") or higher. Secondary outcomes included death from any cause within 28 days and within 6 months after injury.
RESULTS
RESULTS
A total of 1310 patients were recruited by 15 emergency medical services in Australia, New Zealand, and Germany. Of these patients, 661 were assigned to receive tranexamic acid, and 646 were assigned to receive placebo; the trial-group assignment was unknown for 3 patients. Survival with a favorable functional outcome at 6 months occurred in 307 of 572 patients (53.7%) in the tranexamic acid group and in 299 of 559 (53.5%) in the placebo group (risk ratio, 1.00; 95% confidence interval [CI], 0.90 to 1.12; P = 0.95). At 28 days after injury, 113 of 653 patients (17.3%) in the tranexamic acid group and 139 of 637 (21.8%) in the placebo group had died (risk ratio, 0.79; 95% CI, 0.63 to 0.99). By 6 months, 123 of 648 patients (19.0%) in the tranexamic acid group and 144 of 629 (22.9%) in the placebo group had died (risk ratio, 0.83; 95% CI, 0.67 to 1.03). The number of serious adverse events, including vascular occlusive events, did not differ meaningfully between the groups.
CONCLUSIONS
CONCLUSIONS
Among adults with major trauma and suspected trauma-induced coagulopathy who were being treated in advanced trauma systems, prehospital administration of tranexamic acid followed by an infusion over 8 hours did not result in a greater number of patients surviving with a favorable functional outcome at 6 months than placebo. (Funded by the Australian National Health and Medical Research Council and others; PATCH-Trauma ClinicalTrials.gov number, NCT02187120.).
Identifiants
pubmed: 37314244
doi: 10.1056/NEJMoa2215457
doi:
Substances chimiques
Antifibrinolytic Agents
0
Tranexamic Acid
6T84R30KC1
Banques de données
ClinicalTrials.gov
['NCT02187120']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
127-136Subventions
Organisme : National Health and Medical Research Council
ID : APP1044894
Organisme : National Health and Medical Research Council
ID : APP165275
Organisme : Health Research Council of New Zealand
ID : GA216F
Organisme : Lotto New Zealand
ID : 34033
Organisme : Deutsche Forschungsgemeinschaft
ID : MA 2569/6-1
Investigateurs
Russell L Gruen
(RL)
Biswadev Mitra
(B)
Stephen A Bernard
(SA)
Colin J McArthur
(CJ)
Brian Burns
(B)
Dashiell Gantner
(D)
Marc Maegele
(M)
Peter A Cameron
(PA)
Bridget Dicker
(B)
Andrew B Forbes
(AB)
Sally Hurford
(S)
Catherine A Martin
(CA)
Stefan M Mazur
(SM)
Robert L Medcalf
(RL)
Lynnette J Murray
(LJ)
Paul S Myles
(PS)
Sze J Ng
(SJ)
Veronica Pitt
(V)
Stephen Rashford
(S)
Michael C Reade
(MC)
Andrew H Swain
(AH)
Tony Trapani
(T)
Paul J Young
(PJ)
Ann-Marie Baker
(AM)
Zsolt Balogh
(Z)
Camila Battistuzzo
(C)
Jasmin Board
(J)
Grant Christey
(G)
Mark C Fitzgerald
(MC)
Ian Jacobs
(I)
Maija Kaukonen
(M)
Phoebe McCracken
(P)
Tony Smith
(T)
Huyen Tran
(H)
Stephen Bernard
(S)
Shelley Cox
(S)
Peter Crane
(P)
Anthony De Wit
(A)
Ben Meade
(B)
Tracie Naidekoff
(T)
Karen Smith
(K)
Rosemary Carney
(R)
Sophie Dyson
(S)
Sandy Muecke
(S)
Sandra Ware
(S)
Toby Fogg
(T)
Alan Garner
(A)
Elwyn Poynter
(E)
Jason Bendall
(J)
Mary Morgan
(M)
Colin Dibble
(C)
Richard Mahoney
(R)
Blair Hicks
(B)
Hugh Grantham
(H)
Daniel Martin
(D)
Stefan Mazur
(S)
Andrew Pearce
(A)
Ben Stanton
(B)
Daniel Bodnar
(D)
Lachlan Parker
(L)
Steven Raven
(S)
Malcolm Johnston-Leek
(M)
James Gardiner
(J)
Nicky Trikilis
(N)
Garth Herrington
(G)
Jodie Mills
(J)
Mark Ross
(M)
Tom Vidins
(T)
Tim Wallace
(T)
Chris Benjamin
(C)
Michael McDermott
(M)
Paul Scott
(P)
Alexander Wilson
(A)
Jamie Cooper
(J)
Mark Fitzgerald
(M)
Russell Gruen
(R)
Emma-Leah Martin
(EL)
Paul Myles
(P)
Shirley Vallance
(S)
Meredith Young
(M)
Kylie Crisp
(K)
Kellie Gumm
(K)
Rodney Judson
(R)
Jonathan Knott
(J)
Kellie Liersch
(K)
Ben Thomson
(B)
Ramy Bchai
(R)
Oliver Flower
(O)
Geoff Healy
(G)
Anthony Joseph
(A)
James Milligan
(J)
Paul Weir
(P)
Peter Clark
(P)
Andrew Coggins
(A)
Jeremy Hsu
(J)
Anne McShane
(A)
Rachel Watkins
(R)
Charlie Warren
(C)
Maryanne Sewell
(M)
Matthew Verdolini
(M)
Kate King
(K)
Simone Meakes
(S)
Scott D'Armours
(S)
Ian Ferguson
(I)
Sally Forrest-Horder
(S)
Nevenka Francis
(N)
Paul Middleton
(P)
Michael Parr
(M)
Helen Birkin
(H)
Marianne Chapman
(M)
Chris Clark
(C)
Louise de Prinse
(L)
Dan Ellis
(D)
Kathy Heyman
(K)
Xia Jin
(X)
Joanne McIntyre
(J)
Joanna Okeshott
(J)
Brett Sampson
(B)
Tapaswi Shrestha
(T)
David Teubner
(D)
Catherine Hurn
(C)
Melissa Lassig-Smith
(M)
Daryl Wall
(D)
Kim Bottrell
(K)
Don Campbell
(D)
Elizabeth Wake
(E)
James Winearls
(J)
Kathleen McDermott
(K)
Clare McKay
(C)
Ben Piper
(B)
David Read
(D)
Jodie Williams
(J)
David Cooper
(D)
Rick McAllister
(R)
Dan Spearing
(D)
Verity Todd
(V)
Peter Collins
(P)
Andy Swain
(A)
Rachael McConnochie
(R)
Yan Chen
(Y)
Colin McArthur
(C)
Lynette Newby
(L)
Catherine Simmonds
(C)
Jefferson Aguila
(J)
Dinuraj Girijadevi
(D)
Alex Kazemi
(A)
Vivian Lai
(V)
Rima Song
(R)
Alaina Campbell
(A)
Katy Cryer
(K)
April Aguilar
(A)
Nina Beehre
(N)
Kirsha Delaney
(K)
Anna Hunt
(A)
Harriet Judd
(H)
Cassie Lawrence
(C)
Eden Lesona
(E)
Alex Millington
(A)
James Moore
(J)
Leanlove Navarra
(L)
Shaanti Olatunji
(S)
Yvonne Robertson
(Y)
Raulle Sol Cruz
(R)
Rhoze Sol Cruz
(R)
Agnes Vucago-McKay
(A)
Chelsea Young
(C)
Paul Young
(P)
Llesley Chadwick
(L)
Ross Freebairn
(R)
Penelope Park
(P)
Christine Rolls
(C)
Elizabeth Thomas-Vuilleumier
(E)
Louise Trent
(L)
Yves Gramlich
(Y)
Reinhard Hoffmann
(R)
Alexander Wengert
(A)
Ingo Marzi
(I)
Philipp Störmann
(P)
Mathias Woschek
(M)
Andrew B Forbes
(AB)
Amanda Brown
(A)
Paula James
(P)
Helen Markham
(H)
Rebekka van Zyl
(R)
Colin F MacKenzie
(CF)
Hegang Chen
(H)
Eileen M Bulger
(EM)
Karim H Brohi
(KH)
Veronica Pitt
(V)
Nanda Surendram
(N)
Natasha Dodge
(N)
Stephen Bernard
(S)
Colin McArthur
(C)
Yan Chen
(Y)
Sally Hurford
(S)
Marc Maegele
(M)
Martin Schulz
(M)
Commentaires et corrections
Type : CommentIn
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