Cargando…

Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial

BACKGROUND: To assess the efficacy and safety of intravenous and subsequent long-term oral tranexamic acid (TXA) following total knee arthroplasty (TKA) without a tourniquet. METHODS: In this double-blinded trial, 118 patients undergoing primary TKA were randomized into two groups: the patients in g...

Descripción completa

Detalles Bibliográficos
Autores principales: Wang, Hao-Yang, Wang, Liu, Luo, Ze-Yu, Wang, Duan, Tang, Xin, Zhou, Zong-Ke, Pei, Fu-Xing
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814971/
https://www.ncbi.nlm.nih.gov/pubmed/31653221
http://dx.doi.org/10.1186/s12891-019-2885-5
_version_ 1783463101427875840
author Wang, Hao-Yang
Wang, Liu
Luo, Ze-Yu
Wang, Duan
Tang, Xin
Zhou, Zong-Ke
Pei, Fu-Xing
author_facet Wang, Hao-Yang
Wang, Liu
Luo, Ze-Yu
Wang, Duan
Tang, Xin
Zhou, Zong-Ke
Pei, Fu-Xing
author_sort Wang, Hao-Yang
collection PubMed
description BACKGROUND: To assess the efficacy and safety of intravenous and subsequent long-term oral tranexamic acid (TXA) following total knee arthroplasty (TKA) without a tourniquet. METHODS: In this double-blinded trial, 118 patients undergoing primary TKA were randomized into two groups: the patients in group A received intravenous TXA at 20-mg/kg 10 min before the surgery and 3 h postoperatively, and then oral 1 g TXA from postoperative day (POD) 1 to POD 14, and the patients in group B received intravenous TXA at 20-mg/kg 10 min before surgery and 3 h postoperatively, and then oral 1 g placebo from postoperative day (POD) 1 to POD 14. The primary outcome was total blood loss. Secondary outcomes included ecchymosis area and morbidity, postoperative transfusion, postoperative laboratory values, postoperative knee function and length of hospital stay. Complications, and patient satisfaction were also recorded. RESULTS: The mean total blood loss was lower in Group A than in Group B (671.7 ml vs 915.8 ml, P = 0.001). There was no significant difference in the transfusion rate between the two groups. Group A had a higher hemoglobin than Group B on POD 3 (106.0 g/L vs 99.7 g/L, P = 0.001). However, no significant difference was found for Hb or hematocrit on POD 1 or POD 14 between the two groups. Patients in Group A had less ecchymosis morbidity (7 vs 38, P = 0.001), smaller ecchymosis area (1.6 vs 3.0, P = 0.001) than Group B. The blood coagulation level as measured by fibrinolysis (D-Dimer) was lower in Group A than in Group B on POD 1 and POD 3 (4.6 mg/L vs. 8.4 mg/L, respectively, P = 0.001; 1.5 mg/L vs. 3.3 mg/L, respectively, P = 0.001). However, there was no significant difference on POD 14, and the fibrin degradation products showed the same trend. Patients in Group A had less swelling than those in Group B on POD 3 and POD 14. The circumference of the knee was 43.1 cm vs. 46.1 cm (POD 3, P = 0.001) and 41.4 cm vs. 44.9 cm (POD 14, P = 0.001) in Group A vs Group B, respectively. Nevertheless, the circumference of the knee in the two groups was similar on POD 1 and POD 3 M. No significant differences were identified in knee function, pain score, or hospital stay. No significant differences were identified in thromboembolic complications, infection, hematoma, wound healing and patients satisfaction between the two groups. CONCLUSION: Intravenous and subsequent long-term oral TXA produced less blood loss and less swelling and ecchymosis compared with short-term TXA without increasing the risk of complications. TRIAL REGISTRATION: The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-IPR-17012264).
format Online
Article
Text
id pubmed-6814971
institution National Center for Biotechnology Information
language English
publishDate 2019
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-68149712019-10-31 Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial Wang, Hao-Yang Wang, Liu Luo, Ze-Yu Wang, Duan Tang, Xin Zhou, Zong-Ke Pei, Fu-Xing BMC Musculoskelet Disord Research Article BACKGROUND: To assess the efficacy and safety of intravenous and subsequent long-term oral tranexamic acid (TXA) following total knee arthroplasty (TKA) without a tourniquet. METHODS: In this double-blinded trial, 118 patients undergoing primary TKA were randomized into two groups: the patients in group A received intravenous TXA at 20-mg/kg 10 min before the surgery and 3 h postoperatively, and then oral 1 g TXA from postoperative day (POD) 1 to POD 14, and the patients in group B received intravenous TXA at 20-mg/kg 10 min before surgery and 3 h postoperatively, and then oral 1 g placebo from postoperative day (POD) 1 to POD 14. The primary outcome was total blood loss. Secondary outcomes included ecchymosis area and morbidity, postoperative transfusion, postoperative laboratory values, postoperative knee function and length of hospital stay. Complications, and patient satisfaction were also recorded. RESULTS: The mean total blood loss was lower in Group A than in Group B (671.7 ml vs 915.8 ml, P = 0.001). There was no significant difference in the transfusion rate between the two groups. Group A had a higher hemoglobin than Group B on POD 3 (106.0 g/L vs 99.7 g/L, P = 0.001). However, no significant difference was found for Hb or hematocrit on POD 1 or POD 14 between the two groups. Patients in Group A had less ecchymosis morbidity (7 vs 38, P = 0.001), smaller ecchymosis area (1.6 vs 3.0, P = 0.001) than Group B. The blood coagulation level as measured by fibrinolysis (D-Dimer) was lower in Group A than in Group B on POD 1 and POD 3 (4.6 mg/L vs. 8.4 mg/L, respectively, P = 0.001; 1.5 mg/L vs. 3.3 mg/L, respectively, P = 0.001). However, there was no significant difference on POD 14, and the fibrin degradation products showed the same trend. Patients in Group A had less swelling than those in Group B on POD 3 and POD 14. The circumference of the knee was 43.1 cm vs. 46.1 cm (POD 3, P = 0.001) and 41.4 cm vs. 44.9 cm (POD 14, P = 0.001) in Group A vs Group B, respectively. Nevertheless, the circumference of the knee in the two groups was similar on POD 1 and POD 3 M. No significant differences were identified in knee function, pain score, or hospital stay. No significant differences were identified in thromboembolic complications, infection, hematoma, wound healing and patients satisfaction between the two groups. CONCLUSION: Intravenous and subsequent long-term oral TXA produced less blood loss and less swelling and ecchymosis compared with short-term TXA without increasing the risk of complications. TRIAL REGISTRATION: The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-IPR-17012264). BioMed Central 2019-10-25 /pmc/articles/PMC6814971/ /pubmed/31653221 http://dx.doi.org/10.1186/s12891-019-2885-5 Text en © The Author(s). 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Wang, Hao-Yang
Wang, Liu
Luo, Ze-Yu
Wang, Duan
Tang, Xin
Zhou, Zong-Ke
Pei, Fu-Xing
Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
title Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
title_full Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
title_fullStr Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
title_full_unstemmed Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
title_short Intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
title_sort intravenous and subsequent long-term oral tranexamic acid in enhanced-recovery primary total knee arthroplasty without the application of a tourniquet: a randomized placebo-controlled trial
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6814971/
https://www.ncbi.nlm.nih.gov/pubmed/31653221
http://dx.doi.org/10.1186/s12891-019-2885-5
work_keys_str_mv AT wanghaoyang intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial
AT wangliu intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial
AT luozeyu intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial
AT wangduan intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial
AT tangxin intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial
AT zhouzongke intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial
AT peifuxing intravenousandsubsequentlongtermoraltranexamicacidinenhancedrecoveryprimarytotalkneearthroplastywithouttheapplicationofatourniquetarandomizedplacebocontrolledtrial