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PubMed

Záznam pochází z PubMed

Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial

Lamy, André
Autor Lamy, André ORCID Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) Surgery (A.L., R.P.W.), McMaster University, Hamilton, ON, Canada
Sirota, Dmitry A
Autor Sirota, Dmitry A E. Meshalkin National Medical Research Center, Novosibirsk, Russia (D.A.S.)
Jacques, Frederic
Autor Jacques, Frederic Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, Canada (F.J.)
Poostizadeh, Ahmad
Autor Poostizadeh, Ahmad Kelowna General Hospital, BC, Canada (A.P.)
Noiseux, Nicolas
Autor Noiseux, Nicolas Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), QC, Canada (N.N.)
Efremov, Sergey
Autor Efremov, Sergey ORCID Saint Petersburg State University Hospital, Russia (S.E.)
Demers, Philippe
Autor Demers, Philippe Montreal Heart Institute, University of Montréal, QC, Canada (P.D.)
Akselrod, Boris
Autor Akselrod, Boris Petrovsky National Centre of Surgery, Moscow, Russia (B.A.)
Wang, Chew Yin
Autor Wang, Chew Yin ORCID Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.)
Arora, Rakesh C
Autor Arora, Rakesh C ORCID Division of Cardiac Surgery, University Hospitals Harrington Heart and Vascular Institute, Cleveland, OH (R.C.A.) Department of Surgery, Case Western Reserve University, Cleveland, OH (R.C.A.)
Branny, Piotr
Autor Branny, Piotr Department of Cardiac Surgery, Hospital Agel Trinec-Podlesi, Trinec, Czech Republic (P.B.)
McGuinness, Shay P
Autor McGuinness, Shay P Auckland City Hospital, New Zealand (S.P.M.)
Brown, Craig D
Autor Brown, Craig D ORCID New Brunswick Heart Centre, Saint John, Canada (C.D.B.)
Jeanmart, Hugues
Autor Jeanmart, Hugues Centre Intégré Universitaire de Santé et de Services Sociaux du Nord-de-l'Île-de-Montréal, Hôpital du Sacré-Coeur de Montréal, QC, Canada (H.J.)
Zhao, Qiang
Autor Zhao, Qiang ORCID Rujin Hospital, Shanghai, China (Q.Z.) Shanghai Jiao Tong University School of Medicine, China (Q.Z.)
Zhang, Haibo
Autor Zhang, Haibo ORCID Beijing Anzhen Hospital, China (H.Z.)
Belley-Côté, Emilie P
Autor Belley-Côté, Emilie P ORCID Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) Medicine (E.P.B-C., A.E.F-B., S.Y., P.J.D.), McMaster University, Hamilton, ON, Canada
Whitlock, Richard P
Autor Whitlock, Richard P ORCID Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) Surgery (A.L., R.P.W.), McMaster University, Hamilton, ON, Canada
Browne, Austin
Autor Browne, Austin Hamilton Health Sciences, Hamilton General Hospital, Ontario, Canada (A.B.)
Copland, Ingrid
Autor Copland, Ingrid Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.)
Vincent, Jessica
Autor Vincent, Jessica ORCID Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.)
Khatun, Rutaba
Autor Khatun, Rutaba Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.)
Balasubramanian, Kumar
Autor Balasubramanian, Kumar Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.)
Bangdiwala, Shrikant I
Autor Bangdiwala, Shrikant I ORCID Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) Departments of Health Research Methods, Evidence, and Impact (S.I.B., J.S., P.J.D.), McMaster University, Hamilton, ON, Canada
McGillion, Michael H
Autor McGillion, Michael H Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) School of Nursing (M.H.M.), McMaster University, Hamilton, ON, Canada
Fox-Robichaud, Alison E
Autor Fox-Robichaud, Alison E ORCID Medicine (E.P.B-C., A.E.F-B., S.Y., P.J.D.), McMaster University, Hamilton, ON, Canada Thrombosis and Atherosclerosis Research Institute (A.E.F-B.), McMaster University, Hamilton, ON, Canada
Spence, Jessica
Autor Spence, Jessica Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) Departments of Health Research Methods, Evidence, and Impact (S.I.B., J.S., P.J.D.), McMaster University, Hamilton, ON, Canada Anesthesia (J.S.), McMaster University, Hamilton, ON, Canada
Yusuf, Salim
Autor Yusuf, Salim ORCID Population Health Research Institute, Hamilton, ON, Canada (A.L., E.P.B-C., R.P.W., I.C., J.V., R.K., K.B., S.I.B., M.H.M., J.S., S.Y., P.J.D.) Medicine (E.P.B-C., A.E.F-B., S.Y., P.J.D.), McMaster University, Hamilton, ON, Canada
Devereaux, P J
Autor Devereaux, P J ORCID
DEPOSITION Study Group
Autor DEPOSITION Study Group

Circulation. 2024 Oct 22 ; 150 (17) : 1315-1323. [epub] 20240408

ISSN 1524-4539 | 0009-7322
Zdroj

Jazyk angličtina Země Spojené státy americké Médium print-electronic

Typ dokumentu časopisecké články, randomizované kontrolované studie, multicentrická studie, srovnávací studie

Perzistentní odkaz https://www.medvik.cz/link/pmid38587333

PubMed 38587333
DOI 10.1161/circulationaha.124.069606
Knihovny.cz E-zdroje

Klíčová slova
administration, intravenous, administration, topical, blood transfusion, seizures, thoracic surgery, tranexamic acid,
MeSH
antifibrinolytika * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
aplikace lokální * MeSH
dvojitá slepá metoda MeSH
intravenózní podání * MeSH
kardiochirurgické výkony * škodlivé účinky MeSH
krvácení při operaci prevence a kontrola MeSH
kyselina tranexamová * aplikace a dávkování škodlivé účinky terapeutické užití MeSH
lidé středního věku MeSH
lidé MeSH
senioři MeSH
výsledek terapie MeSH
záchvaty prevence a kontrola etiologie MeSH
Check Tag
lidé středního věku MeSH
lidé MeSH
mužské pohlaví MeSH
senioři MeSH
ženské pohlaví MeSH
Publikační typ
časopisecké články MeSH
multicentrická studie MeSH
randomizované kontrolované studie MeSH
srovnávací studie MeSH
Názvy látek
antifibrinolytika * MeSH
kyselina tranexamová * MeSH

BACKGROUND: Although intravenous tranexamic acid is used in cardiac surgery to reduce bleeding and transfusion, topical tranexamic acid results in lower plasma concentrations compared with intravenous tranexamic acid, which may lower the risk of seizures. We aimed to determine whether topical tranexamic acid reduces the risk of in-hospital seizure without increasing the risk of transfusion among cardiac surgery patients. METHODS: We conducted a multicenter, double dummy, blinded, randomized controlled trial of patients recruited by convenience sampling in academic hospitals undergoing cardiac surgery with cardiopulmonary bypass. Between September 17, 2019, and November 28, 2023, a total of 3242 patients from 16 hospitals in 6 countries were randomly assigned (1:1 ratio) to receive either intravenous tranexamic acid (control) through surgery or topical tranexamic acid (treatment) at the end of surgery. The primary outcome was seizure, and the secondary outcome was red blood cell transfusion. After the last planned interim analysis, when 75% of anticipated participants had completed follow up, the data and safety monitoring board recommended to terminate the trial, and upon unblinding, the operations committee stopped the trial for safety. RESULTS: Among 3242 randomized patients (mean age, 66.0 years; 77.7% male), in-hospital seizure occurred in 4 of 1624 patients (0.2%) in the topical group, and 11 of 1628 patients (0.7%) in the intravenous group (absolute risk difference, -0.5% [95% CI, -0.9 to 0.03]; P=0.07). Red blood cell transfusion occurred in 570 patients (35.1%) in the topical group and in 433 (26.8%) in the intravenous group (absolute risk difference, 8.3% [95% CI, 5.2-11.5]; P=0.007). The absolute risk difference in transfusion of ≥4 units of red blood cells in the topical group compared with the intravenous group was 8.2% (95% CI, 3.4-12.9). CONCLUSIONS: Among patients undergoing cardiac surgery, topical administration of tranexamic acid resulted in an 8.3% absolute increase in transfusion without reducing the incidence of seizure, compared with intravenous tranexamic acid. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03954314.

Anesthesia McMaster University Hamilton ON Canada

Auckland City Hospital New Zealand

Beijing Anzhen Hospital China

Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Centre Intégré Universitaire de Santé et de Services Sociaux du Nord de l'Île de Montréal Hôpital du Sacré Coeur de Montréal QC Canada

Department of Anesthesiology Faculty of Medicine University of Malaya Kuala Lumpur Malaysia

Department of Cardiac Surgery Hospital Agel Trinec Podlesi Trinec Czech Republic

Department of Surgery Case Western Reserve University Cleveland OH

Departments of Health Research Methods Evidence and Impact McMaster University Hamilton ON Canada

Division of Cardiac Surgery University Hospitals Harrington Heart and Vascular Institute Cleveland OH

E Meshalkin National Medical Research Center Novosibirsk Russia

Hamilton Health Sciences Hamilton General Hospital Ontario Canada