-
Something wrong with this record ?
Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial
A. Lamy, DA. Sirota, F. Jacques, A. Poostizadeh, N. Noiseux, S. Efremov, P. Demers, B. Akselrod, CY. Wang, RC. Arora, P. Branny, SP. McGuinness, CD. Brown, H. Jeanmart, Q. Zhao, H. Zhang, EP. Belley-Côté, RP. Whitlock, A. Browne, I. Copland, J....
Language English Country United States
Document type Journal Article, Randomized Controlled Trial, Multicenter Study, Comparative Study
NLK
Free Medical Journals
from 1950 to 1 year ago
Open Access Digital Library
from 1950-01-01
Open Access Digital Library
from 1950-01-01
- MeSH
- Antifibrinolytic Agents * administration & dosage adverse effects therapeutic use MeSH
- Administration, Topical * MeSH
- Double-Blind Method MeSH
- Administration, Intravenous * MeSH
- Cardiac Surgical Procedures * adverse effects MeSH
- Blood Loss, Surgical prevention & control MeSH
- Tranexamic Acid * administration & dosage adverse effects therapeutic use MeSH
- Middle Aged MeSH
- Humans MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Seizures prevention & control etiology MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
- Comparative Study 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
Centre de Recherche du Centre Hospitalier de l'Université de Montréal
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
E Meshalkin National Medical Research Center Novosibirsk Russia
Hamilton Health Sciences Hamilton General Hospital Ontario Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec Université Laval Québec Canada
Kelowna General Hospital BC Canada
Medicine McMaster University Hamilton ON Canada
Montreal Heart Institute University of Montréal QC Canada
New Brunswick Heart Centre Saint John Canada
Petrovsky National Centre of Surgery Moscow Russia
Population Health Research Institute Hamilton ON Canada
Saint Petersburg State University Hospital Russia
School of Nursing McMaster University Hamilton ON Canada
Shanghai Jiao Tong University School of Medicine China
Surgery McMaster University Hamilton ON Canada
Thrombosis and Atherosclerosis Research Institute McMaster University Hamilton ON Canada
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc25003834
- 003
- CZ-PrNML
- 005
- 20250206104729.0
- 007
- ta
- 008
- 250121s2024 xxu f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1161/CIRCULATIONAHA.124.069606 $2 doi
- 035 __
- $a (PubMed)38587333
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxu
- 100 1_
- $a Lamy, André $u 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.) $u Surgery (A.L., R.P.W.), McMaster University, Hamilton, ON, Canada $1 https://orcid.org/0000000327777621
- 245 10
- $a Topical Versus Intravenous Tranexamic Acid in Patients Undergoing Cardiac Surgery: The DEPOSITION Randomized Controlled Trial / $c A. Lamy, DA. Sirota, F. Jacques, A. Poostizadeh, N. Noiseux, S. Efremov, P. Demers, B. Akselrod, CY. Wang, RC. Arora, P. Branny, SP. McGuinness, CD. Brown, H. Jeanmart, Q. Zhao, H. Zhang, EP. Belley-Côté, RP. Whitlock, A. Browne, I. Copland, J. Vincent, R. Khatun, K. Balasubramanian, SI. Bangdiwala, MH. McGillion, AE. Fox-Robichaud, J. Spence, S. Yusuf, PJ. Devereaux, DEPOSITION Study Group
- 520 9_
- $a 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.
- 650 _2
- $a lidé $7 D006801
- 650 12
- $a kyselina tranexamová $x aplikace a dávkování $x škodlivé účinky $x terapeutické užití $7 D014148
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 12
- $a kardiochirurgické výkony $x škodlivé účinky $7 D006348
- 650 _2
- $a senioři $7 D000368
- 650 12
- $a aplikace lokální $7 D000287
- 650 12
- $a intravenózní podání $7 D061605
- 650 12
- $a antifibrinolytika $x aplikace a dávkování $x škodlivé účinky $x terapeutické užití $7 D000933
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a záchvaty $x prevence a kontrola $x etiologie $7 D012640
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a výsledek terapie $7 D016896
- 650 _2
- $a krvácení při operaci $x prevence a kontrola $7 D016063
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a srovnávací studie $7 D003160
- 700 1_
- $a Sirota, Dmitry A $u E. Meshalkin National Medical Research Center, Novosibirsk, Russia (D.A.S.)
- 700 1_
- $a Jacques, Frederic $u Institut Universitaire de Cardiologie et de Pneumologie de Québec, Université Laval, Québec, Canada (F.J.)
- 700 1_
- $a Poostizadeh, Ahmad $u Kelowna General Hospital, BC, Canada (A.P.)
- 700 1_
- $a Noiseux, Nicolas $u Centre de Recherche du Centre Hospitalier de l'Université de Montréal (CRCHUM), QC, Canada (N.N.)
- 700 1_
- $a Efremov, Sergey $u Saint Petersburg State University Hospital, Russia (S.E.) $1 https://orcid.org/0000000155819169
- 700 1_
- $a Demers, Philippe $u Montreal Heart Institute, University of Montréal, QC, Canada (P.D.)
- 700 1_
- $a Akselrod, Boris $u Petrovsky National Centre of Surgery, Moscow, Russia (B.A.)
- 700 1_
- $a Wang, Chew Yin $u Department of Anesthesiology, Faculty of Medicine, University of Malaya, Kuala Lumpur, Malaysia (C.Y.W.) $1 https://orcid.org/0000000290663830
- 700 1_
- $a Arora, Rakesh C $u Division of Cardiac Surgery, University Hospitals Harrington Heart and Vascular Institute, Cleveland, OH (R.C.A.) $u Department of Surgery, Case Western Reserve University, Cleveland, OH (R.C.A.) $1 https://orcid.org/0000000257993619
- 700 1_
- $a Branny, Piotr $u Department of Cardiac Surgery, Hospital Agel Trinec-Podlesi, Trinec, Czech Republic (P.B.)
- 700 1_
- $a McGuinness, Shay P $u Auckland City Hospital, New Zealand (S.P.M.)
- 700 1_
- $a Brown, Craig D $u New Brunswick Heart Centre, Saint John, Canada (C.D.B.) $1 https://orcid.org/0000000260777263
- 700 1_
- $a Jeanmart, Hugues $u 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.)
- 700 1_
- $a Zhao, Qiang $u Rujin Hospital, Shanghai, China (Q.Z.) $u Shanghai Jiao Tong University School of Medicine, China (Q.Z.) $1 https://orcid.org/0000000289303854
- 700 1_
- $a Zhang, Haibo $u Beijing Anzhen Hospital, China (H.Z.) $1 https://orcid.org/0000000172493113
- 700 1_
- $a Belley-Côté, Emilie P $u 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.) $u Medicine (E.P.B-C., A.E.F-B., S.Y., P.J.D.), McMaster University, Hamilton, ON, Canada $1 https://orcid.org/000000025071076X
- 700 1_
- $a Whitlock, Richard P $u 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.) $u Surgery (A.L., R.P.W.), McMaster University, Hamilton, ON, Canada $1 https://orcid.org/0000000268635884
- 700 1_
- $a Browne, Austin $u Hamilton Health Sciences, Hamilton General Hospital, Ontario, Canada (A.B.)
- 700 1_
- $a Copland, Ingrid $u 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.)
- 700 1_
- $a Vincent, Jessica $u 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.) $1 https://orcid.org/0000000223568876
- 700 1_
- $a Khatun, Rutaba $u 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.)
- 700 1_
- $a Balasubramanian, Kumar $u 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.)
- 700 1_
- $a Bangdiwala, Shrikant I $u 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.) $u Departments of Health Research Methods, Evidence, and Impact (S.I.B., J.S., P.J.D.), McMaster University, Hamilton, ON, Canada $1 https://orcid.org/0000000231110689
- 700 1_
- $a McGillion, Michael H $u 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.) $u School of Nursing (M.H.M.), McMaster University, Hamilton, ON, Canada
- 700 1_
- $a Fox-Robichaud, Alison E $u Medicine (E.P.B-C., A.E.F-B., S.Y., P.J.D.), McMaster University, Hamilton, ON, Canada $u Thrombosis and Atherosclerosis Research Institute (A.E.F-B.), McMaster University, Hamilton, ON, Canada $1 https://orcid.org/0000000199123606
- 700 1_
- $a Spence, Jessica $u 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.) $u Departments of Health Research Methods, Evidence, and Impact (S.I.B., J.S., P.J.D.), McMaster University, Hamilton, ON, Canada $u Anesthesia (J.S.), McMaster University, Hamilton, ON, Canada
- 700 1_
- $a Yusuf, Salim $u 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.) $u Medicine (E.P.B-C., A.E.F-B., S.Y., P.J.D.), McMaster University, Hamilton, ON, Canada $1 https://orcid.org/0000000347765601 $7 nlk20040153098
- 700 1_
- $a Devereaux, P J $1 https://orcid.org/000000032935637X
- 710 2_
- $a DEPOSITION Study Group
- 773 0_
- $w MED00001091 $t Circulation (New York, N.Y.) $x 1524-4539 $g Roč. 150, č. 17 (2024), s. 1315-1323
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/38587333 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y - $z 0
- 990 __
- $a 20250121 $b ABA008
- 991 __
- $a 20250206104725 $b ABA008
- 999 __
- $a ok $b bmc $g 2263538 $s 1239841
- BAS __
- $a 3
- BAS __
- $a PreBMC-MEDLINE
- BMC __
- $a 2024 $b 150 $c 17 $d 1315-1323 $e 20240408 $i 1524-4539 $m Circulation (New York, N.Y.) $n Circulation $x MED00001091
- LZP __
- $a Pubmed-20250121
