Effect of carbazochrome sodium sulfonate combined with tranexamic acid on blood loss and inflammatory response in patients undergoing total hip arthroplasty
Bone & joint research. 2021;10(6):354-362
AIMS: The purpose of this study was to examine the efficacy and safety of carbazochrome sodium sulfonate (CSS) combined with tranexamic acid (TXA) on blood loss and inflammatory responses after primary total hip arthroplasty (THA), and to investigate the influence of different administration methods of CSS on perioperative blood loss during THA. METHODS This study is a randomized controlled trial involving 200 patients undergoing primary unilateral THA. A total of 200 patients treated with intravenous TXA were randomly assigned to group A (combined intravenous and topical CSS), group B (topical CSS), group C (intravenous CSS), or group D (placebo). RESULTS Mean total blood loss (TBL) in groups A (605.0 ml (SD 235.9)), B (790.9 ml (SD 280.7)), and C (844.8 ml (SD 248.1)) were lower than in group D (1,064.9 ml (SD 318.3), p < 0.001). We also found that compared with group D, biomarker level of inflammation, transfusion rate, pain score, and hip range of motion at discharge in groups A, B, and C were significantly improved. There were no differences among the four groups in terms of intraoperative blood loss (IBL), intramuscular venous thrombosis (IMVT), and length of hospital stay (LOS). CONCLUSION The combined application of CSS and TXA is more effective than TXA alone in reducing perioperative blood loss and transfusion rates, inflammatory response, and postoperative hip pain, results in better early hip flexion following THA, and did not increase the associated venous thromboembolism (VTE) events. Intravenous combined with topical injection of CSS was superior to intravenous or topical injection of CSS alone in reducing perioperative blood loss. Cite this article: Bone Joint Res 2021;10(6):354-362.
Effects of carbazochrome sodium sulfonate combined with tranexamic acid on hemostasis and inflammation during perioperative period of total hip arthroplasty: a randomized controlled trial
Orthopaedics & traumatology, surgery & research : OTSR. 2021;:103092
BACKGROUND The hemostatic effect of tranexamic acid (TXA) combined with carbazochrome sodium sulfonate (CSS) in total hip arthroplasty (THA) has not been determined. Therefore we performed a randomized study aiming to evaluate the effects of CSS combined with TXA on perioperative blood loss and inflammatory response of THA. HYPOTHESIS CSS combined with TXA can effectively reduce perioperative blood loss and immune response compared to TXA. MATERIAL AND METHODS This randomized placebo-controlled trial assigned 150 patients undergoing unilateral primary total hip arthroplasty who underwent direct anterior approach surgery to 3 groups: group A received TXA plus topical CSS; group B received TXA only; and group C received placebo. The main outcome was total blood loss. Secondary outcomes included reduction in hemoglobin concentration, coagulation parameters, inflammatory marker levels, perioperative visual analog scale (VAS) pain score, transfusion rates, postoperative hospital stay, and incidence of thromboembolic events. RESULTS Total blood loss in group A (668.84±230.95mL) was lower than in group B (940.96±359.22 mL) and C (1166.52±342.85 mL, p < 0.05). We also found that compared with group B, postoperative hip pain, biomarker level of inflammation, visual analogue score (VAS) pain score in group A were significantly improved. The transfusion rate and unit of group A were significantly lower than group C (8 patients ; 17.5 units), but there was no statistical difference between group A (no transfusion) and group B (2 patients; 4 units). No differences were observed in thromboembolic and other outcomes among the groups. DISCUSSION The combined application of topic CSS and TXA is more effective than TXA alone following THA in regard of reducing total blood loss. In addition, CSS combined with TXA is better than TXA alone in terms of improving postoperative hip pain and reducing the level of inflammatory factors. LEVEL OF EVIDENCE I; randomized controlled study.
Hemostatic and Anti-Inflammatory Effects of Carbazochrome Sodium Sulfonate in Patients Undergoing Total Knee Arthroplasty: A Randomized Controlled Trial
The Journal of arthroplasty. 2019
BACKGROUND Postoperative recovery after total knee arthroplasty (TKA) is associated with postoperative anemia, allogeneic transfusion, and stress immune responses to surgery. Carbazochrome sodium sulfonate (CSS) reduces bleeding through several mechanisms. We assessed the effect of CSS combined with tranexamic acid (TXA) on postoperative anemia, blood transfusion, and inflammatory responses. METHODS This study was designed as a randomized, placebo-controlled trial of 200 patients undergoing unilateral primary TKA. Patients were divided into 4 groups: group A received TXA plus topical and intravenous CSS; group B received TXA plus topical CSS only; group C received TXA plus intravenous CSS only; group D received TXA only. RESULTS Total blood loss in groups A (609.92 +/- 221.24 mL), B (753.16 +/- 247.67 mL), and C (829.23 +/- 297.45 mL) was lower than in group D (1158.26 +/- 334.13 mL, P < .05). There was no difference in total blood loss between groups B and C. We also found that compared with group D, the postoperative swelling rate, biomarker level of inflammation, visual analog scale pain score, and range of motion at discharge in groups A, B, and C were significantly improved (P < .05). No thromboembolic complications occurred. There were no differences in transfusion rate, intraoperative blood loss, platelet count, or average length of stay among the 4 groups (P > .05). CONCLUSION CSS combined with TXA was more effective than TXA alone in reducing perioperative blood loss and inflammatory response and did not increase the incidence of thromboembolism complications.
Efficacy of oral tranexamic acid on blood loss in primary total hip arthroplasty using a direct anterior approach: a prospective randomized controlled trial
International Orthopaedics. 2018;42((11):):2535-2542
BACKGROUND Tranexamic acid (TXA), delivered intravenously or topically, has been shown to reduce blood loss, the need for transfusion, and relevant healthcare costs when administered in primary standard total hip arthroplasty (THA). Whether the same is true of oral TXA is unclear, the purpose of this study was to determine if oral tranexamic acid is equivalent to intravenous TXA in the case of patients undergoing THA via the direct anterior approach. METHODS In this prospective randomized controlled trial, 120 patients undergoing primary THA by the direct anterior approach were randomized to receive oral TXA (two doses of 20 mg/kg), intravenous TXA (two doses of 15 mg/kg), or no TXA. Primary outcomes were haemoglobin drop, haematocrit levels, total blood loss, intra-operative blood loss, need for transfusion, and volume transfused. Secondary outcomes included thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission. RESULTS Demographic characteristics were similar among the three patient groups (p > 0.05, n = 40 per group). Haemoglobin drop, haematocrit levels, total blood loss, and intra-operative blood loss were similar in the oral and intravenous groups (p > 0.05), and significantly smaller than in the control group (p < 0.05). Transfusions were given to significantly fewer patients in the oral group (3%) and intravenous group (6%) than in the control group (27%, p = 0.01). Costs of TXA and transfusions were significantly lower in the oral group than the intravenous group (p < 0.05). The three groups were similar in thromboembolic events, wound complications, the length of post-operative hospital stay, and 30-day readmission (p > 0.05). CONCLUSION Oral TXA shows similar efficacy and safety as intravenous TXA for reducing haemoglobin drop, haematocrit levels, total blood loss, and transfusion rate following THA by the direct anterior approach. Therefore, the much less-expensive oral formulation may be superior to the intravenous form.
Influence of tourniquet use in primary total knee arthroplasty with drainage: a prospective randomised controlled trial
Journal of Orthopaedic Surgery and Research. 2017;12((1)):172.
BACKGROUND We aimed to compare the effect of tourniquet use or lack of it on recovery following uncomplicated primary total knee arthroplasty (TKA). METHODS In a prospective randomised double-blinded study, 150 patients undergoing primary TKA were assigned to either a tourniquet or non-tourniquet group. At the early phase, 3 and 6 months after surgery, an independent observer assessed the primary outcome measure (i.e. total blood loss) and secondary outcome measures (i.e. wound complications, visual analogue scale pain score and knee range of motion). RESULTS The tourniquet group exhibited reduced intraoperative blood loss (215.7 +/- 113.7 ml vs. 138.6 +/- 93.9 ml, P < 0.001) and shorter operating time (77.2 +/- 14.5 min vs. 82.0 +/- 12.7 min, P = 0.038). However, the non-tourniquet group showed less postoperative blood loss (180.2 +/- 117.0 ml vs. 253.7 +/- 144.2 ml, P = 0.001) and drainage volume (89.2 +/- 66.3 ml vs. 164.5 +/- 97.8 ml, P = 0.004), less thigh pain (all P < 0.001) in the initial 3 weeks, better knee range of motion (ROM) in the initial 3 days (day 1 81.6 +/- 17.1 vs. 75.95 +/- 14.55, P = 0.036; day 3 99.8 +/- 13.7 vs. 93.95 +/- 11.15, P = 0.005) and fewer wound tension vesicles (10.3 vs. 29.2%, P = 0.005). Earlier straight-leg raising (4.6 +/- 3.8 h vs. 6.4 +/- 4.3 h, P = 0.01) and shorter length of stay (6.3 +/- 1.7 days vs. 7.1 +/- 1.9 days, P = 0.001) were found in the non-tourniquet group. Similar total blood loss and blood transfusion rate were observed for both groups. All other parameters revealed no significant differences. CONCLUSIONS Our study suggests that a non-tourniquet TKA would lead to early rehabilitation without increasing side effects. TRIAL REGISTRATION Chinese Clinical Trials Registry, ChiCTR-IOR-16007851 , 1/29/2016.
Combined use of intravenous and topical tranexamic acid following cementless total hip arthroplasty: a randomised clinical trial
Hip International. 2016;26((1)):36-42.
PURPOSE This study was designed to compare the efficacy and safety of the combined use of tranexamic acid (TXA) with the intravenous (IV) or local use alone in total hip arthroplasty (THA). METHODS 210 patients were randomised to a IV group, a local group or a combined group. Participants received 1.5 g IV-TXA in the IV group, 3 g local TXA in the local group, or 1 g IV-TXA combined with 2 g local TXA in the combined group. The primary outcomes were total blood loss (TBL), maximum haemoglobin drop, and the incidence of deep venous thrombosis (DVT) and pulmonary embolism (PE). RESULTS TBL was (776.75 +/- 188.95) ml in the combined group, which was significantly lower than in the IV group or the local group (p = 0.015, p = 0.001 respectively). Likewise, the mean values of maximum hemoglobin drop in the combined, IV, and local groups were 2.98 +/- 0.78, 3.36 +/- 0.78, and 3.89 +/- 0.72 g/dL, respectively, with a significant intergroup difference (plt;0.001 for all). Asymptomatic DVT was detected in 1 patient of the IV group, and 2 patients of the combined group with the use of ultrasound. There were no episodes of PE, and no significant differences were seen between groups in terms of complications. CONCLUSIONS Combined use of intravenous TXA and local TXA in primary unilateral THA can effectively decrease total blood loss and increase postoperative haemoglobin levels without influencing complication rates. It is suggested that this combined TXA regimen is more effective in decreasing blood loss in cementeless THA than intravenous or local administration alone.
Single-dose tranexamic acid for reducing bleeding and transfusions in total hip arthroplasty: a double-blind, randomized controlled trial of different doses
Thrombosis Research. 2016;141:119-123.
BACKGROUND Tranexamic acid can be effective at decreasing blood loss and transfusion requirements associated with total hip arthroplasty (THA), but few studies have compared the efficacy of different intravenous dosing regimes. This double-blind, randomized controlled trial compared the ability of two doses of intravenous TXA (IV-TXA, 10 or 15mg/kg) to reduce bleeding and transfusions associated with THA. MATERIALS AND METHODS A total of 124 patients scheduled for THA were consecutively randomized 1:1:1 into three parallel arms: control (placebo), 10mg/kg IV-TXA and 15mg/kg IV-TXA. RESULTS The proportion of patients who experienced bleeding and required transfusions was significantly lower in the 15mg/kg IV-TXA group (1 of 42, 2.4%) than in the 10mg/kg IV-TXA group (8 of 39, 20.5%; P=0.012) and in the control group (10 of 38, 26.3%; P=0.002). In fact, this proportion was similar between the 10mg/kg IV-TXA and control groups (P=0.547). Ultrasound examination on postoperative day 3 revealed only one case of asymptomatic deep vein thrombosis (in the femoral vein) in the 10mg/kg IV-TXA group, which was managed by administering low-molecular-weight heparin. No cases of deep-vein thrombosis were observed in the other two groups. No cases of symptomatic pulmonary embolism were observed. CONCLUSION IV-TXA at 10mg/kg significantly reduced blood loss and mitigated the decrease in hemoglobin and hematocrit after THA, but it did not significantly reduce the need for transfusions. In contrast, a dose of 15mg/kg reduced both bleeding and transfusion requirements. Our results argue for a dose of 15mg/kg when using single-dose IV-TXA. LEVEL OF EVIDENCE Therapeutic Level I.
Is postoperative cell salvage necessary in total hip or knee replacement? A meta-analysis of randomized controlled trials
International Journal Of Surgery. 2015;21:135-44.
OBJECTIVE The purpose of this study was to determine whether there are hematological or clinical differences with the use of postoperative cell salvage after total knee (TKR) and hip replacement (THR). METHODS A systematic literature review based on PubMed, EMBASE, the Cochrane Library Database in any language regarding postoperative cell salvage following TKR or THR was performed. High quality of randomized controlled trials were identified. The data was analyzed using Rev Man 5.2. RESULTS 19 randomized controlled trials (12 in TKR, 4 in THR and 3 in both) about 3482 patients were identified and included in this meta-analysis. Postoperative cell salvage significantly reduced the allogeneic blood transfusion requirement after TKR (RR = 0.46, 95% CI = 0.30 to 0.72) and THR (RR = 0.46, 95%CI = 0.32 to 0.68). It also demonstrated a higher level of postoperative Hemoglobin (MD = 0.26 g/dL, 95%CI = 0.15 to 0.37) with the use of postoperative cell salvage. No significant differences were detected regarding length of hospital stay, the incidence of febrile reaction, wound infection and deep vein thrombosis. CONCLUSION The results strengthen the fact that postoperative cell salvage is effective and safe to reduce the rate of transfusion after TKR and THR. As the relatively poor methodological quality and heterogeneity, further research is needed to confirm its safety and cost-effectiveness.Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.
Effect of topical tranexamic acid in reducing bleeding and transfusions in TKA
EDUCATIONAL OBJECTIVES As a result of reading this article, physicians should be able to: 1. Recognize the efficacy and safety of topical tranexamic acid (TXA) for reducing bleeding and transfusions in total knee arthroplasty (TKA). 2. Describe the main methods of application of topical TXA in TKA. 3. Identify the potential advantages of topical TXA compared with intravenous TXA. 4. Recognize the possible differences between high-concentration and low-concentration topical TXA in reducing bleeding and transfusions in TKA. Intravenous tranexamic acid (TXA) has been identified to be effective in total knee arthroplasty (TKA), but the effect of topical application is still unclear. Therefore, the authors conducted a meta-analysis to assess the effect of topical TXA in TKA. Twelve trials with a total of 1179 knees were included. The results revealed that the application of topical TXA in TKA significantly reduced total blood loss by a mean of 280.65 mL and reduced transfusions without increasing the risks of deep venous thrombosis and pulmonary embolism. Topical TXA also reduced postoperative drain output by a mean of 194.59 mL and lowered postoperative hemoglobin drop by a mean of 0.66 g/dL. In addition, subgroup analysis showed that high-concentration TXA may be better at reducing bleeding and transfusions than low-concentration TXA. Therefore, the authors concluded that topical TXA can effectively reduce bleeding and transfusion rate in TKA without increasing the risk of deep venous thrombosis and pulmonary embolism, and high-concentration (20 mg/mL or more) topical TXA is recommended. [Orthopedics. 2015; 38(5):315-324.]. Copyright 2015, SLACK Incorporated.
Topical application of tranexamic acid in primary total hip arthroplasty: a randomized double-blind controlled trial
Journal of Arthroplasty. 2014;29((12):):2452-6.
So far, studies of topical tranexamic acid (TXA) in total hip arthroplasty (THA) were still lacking and controversial. We conducted this randomized double-blind controlled trial which included 101 patients to assess the effect of a high-dose 3g topical TXA in THA. The results showed that 3g topical TXA could significantly reduce transfusions from 22.4% to 5.7% (P<0.05) without increasing the risk of deep vein thrombosis (DVT), pulmonary embolism (PE) and other complications. In addition, topical TXA significantly reduced total blood loss, reduced drain blood loss, and the drops of HB and HCT in topical TXA group were lower than control group. We concluded that 3g topical TXA was effective and safe in reducing bleeding and transfusions in THA. Copyright 2014 Elsevier Inc. All rights reserved.