scholarly journals Comparison of Effects of a Thrombin-Based Hemostatic Agent and Topical Tranexamic Acid on Blood Loss in Patients with Preexisting Thromboembolic Risk Undergoing a Minimally Invasive Total Knee Arthroplasty. A Prospective Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Shih-Hsiang Yen ◽  
Po-Chun Lin ◽  
Cheng-Ta Wu ◽  
Jun-Wen Wang

Background. The efficacy of a thrombin-based hemostatic agent (Floseal®) on reducing postoperative blood loss after total knee arthroplasty (TKA) was still unclear. The aim of our study was to conduct a prospective randomized controlled study to compare the blood conservation effects of Floseal® and topical TXA in patients with preexisting thromboembolic risk undergoing primary minimally invasive TKA. Methods. Our power analysis of this study was based upon the following description, to obtain a statistical power of 0.90 and an alpha error of 0.05, 30 patients were required in each group. Therefore, we enrolled a total of 103 patients with at least one of the risk factors for thromboembolism who underwent unilateral primary minimally invasive TKA, and the participants were randomly divided into the topical TXA group ( n = 34 ), receiving intra-articular injection of 3 g of TXA in 100 mL saline after TKA, the topical Floseal® group ( n = 34 ), receiving 10 mL of Floseal® intra-articularily during surgery, and the placebo group ( n = 35 ), receiving an intra-articular saline injection only. The total blood loss (TBL) and hemoglobin (Hb) drop were compared among the 3 groups. Results. The TXA group had a lower TBL of 645 mL (227 to 1090) in comparison with 1145 mL (535 to 1942) in the Floseal® group and 1103 mL (424 to 1711) in the placebo ( p < 0.001 , respectively). The TBL was similar between the Floseal® group and the placebo group ( p = 0.819 ). No patients in any group had symptoms of venous thromboemblism. Conclusion. Our prospective randomized controlled study showed that intra-articular application of TXA was superior to hemostatic matrix (Floseal®) in terms of blood conservation in patients with preexisting thromboembolic risk undergoing minimally invasive TKA. This trial is registered with Clinicaltrials.gov (NCT02865174) on 08/09/2016.

Author(s):  
Chaofan Zhang ◽  
Chun Hoi Yan ◽  
Ping Keung Chan ◽  
Henry Fu ◽  
Kwong Yuen Chiu

Abstract Background The use and the optimal timing of tourniquet during primary total knee arthroplasty (TKA) is controversial. Most previous studies failed to show clinically significant differences in different strategies. The aim of this study was to determine how three strategies of tourniquet application affect the outcome in TKA patients. Methods This was a prospective randomized controlled study. Patients who undergo TKA were randomized into one of the three groups (1:1:1 ratio): tourniquet inflated from skin incision to cement hardening, tourniquet from cement application to hardening, and tourniquet from skin incision to skin closure. The perioperative blood loss, limb swelling, and complications were recorded. The level of hemoglobin, hematocrit, C-reactive protein (CRP), interleukin (IL)-6, creatine kinase (CK), and lactate dehydrogenase (LDH) were determined. Patients' thigh and TKA wound pain, Knee Society knee score (KSKS) and Knee Society functional assessment (KSFA) scores, and rehabilitation parameters were evaluated. Results A total of 90 patients were enrolled. The baseline characteristics were comparable. We only found significant difference in the intraoperative blood loss (skin to cement: 58.7 ± 36.1 mL, cement-only: 147.8 ± 107.9 mL, skin to skin: 16.3 ± 13.1 mL, p < 0.0001). There were no statistical differences in postoperative drainage, thigh/knee circumference, change of hemoglobin/hematocrit, CRP, IL-6, CK, and LDH on day 1 to day 4 after surgery. The thigh/TKA wound Visual Analogue Scale scores, KSKS score, KSFA score, and rehabilitation parameters were not significantly different at up to 6-month follow-up. No thromboembolic events were noted. Conclusion Our results revealed that there was no best tourniquet strategy in TKA. Different tourniquet methods can be utilized based on surgeon preference without affecting outcomes.


2017 ◽  
Vol 2017 ◽  
pp. 1-8 ◽  
Author(s):  
Feng-Chih Kuo ◽  
Bradley Chen ◽  
Mel S. Lee ◽  
Shih-Hsiang Yen ◽  
Jun-Wen Wang

The use of modern surgical dressings to prevent wound complications and surgical site infection (SSI) after minimally invasive total knee arthroplasty (MIS-TKA) is lacking. In a prospective, randomized, controlled study, 240 patients were randomized to receive either AQUACEL Ag Surgical dressing (study group) or a standard dressing (control group) after MIS-TKA. The primary outcome was wound complication (SSI and blister). The secondary outcomes were wear time and number of dressing changes in the hospital and patient satisfaction (pain, comfort, and ease of use). In the intention-to-treat analysis, there was a significant reduction in the incidence of superficial SSI (0.8%, 95% CI∶ 0.00–2.48) in the study group compared to 8.3% (95% CI∶ 3.32–13.3) in the control group (p=0.01). There were no differences in blister and deep/organ-space SSIs between the two groups. Multivariate analysis revealed that AQUACEL Ag Surgical dressing was an independent risk factor for reduction of SSI (odds ratio: 0.07, 95% CI: 0.01–0.58, p=0.01). The study group had longer wear time (5.2±0.7 versus 1.7±0.4 days, p<0.0001) and lower number of dressing changes (1.0±0.2 versus 3.6±1.3 times, p<0.0001). Increased patient satisfaction (p<0.0001) was also noted in the study group. AQUACEL Ag Surgical dressing is an ideal dressing to provide wound care efficacy, patient satisfaction, reduction of SSI, and cost-effectiveness following MIS-TKA.


2016 ◽  
Vol 30 (07) ◽  
pp. 675-681 ◽  
Author(s):  
Alberto Ruffilli ◽  
Francesco Traina ◽  
Isabella Corneti ◽  
Domenico Fenga ◽  
Sandro Giannini ◽  
...  

Total knee arthroplasty (TKA) is a widely accepted and successful procedure for end-stage arthritis. Nevertheless, fast-track may be compromised by many factors, such as pain, edema, and blood loss. Cryotherapy has been advocated as a safe and effective strategy to improve the postoperative results, acting on pain, edema, and blood loss. This study is a prospective randomized controlled study, involving 50 patients after primary TKA. A power analysis was performed preoperatively. Twenty-four patients were addressed to a postoperative treatment with a continuous cold flow device (Hilotherm, Hilotherm GmbH, Germany). Twenty-six patients represented the control group, treated with crushed ice packs. All the patients shared the same analgesic strategy and the same rehabilitation protocol. Pain, analgesic consumption, active knee range of motion, drain output, transfusion requirement, and total blood loss were evaluated at different follow-ups (postoperative first, third, and seventh days). The two groups were homogenous for preoperative and intraoperative features. The groups showed no statistically significant differences in all the evaluated parameters. A modest reduction of knee volume was evident after 7 days from surgery (trend). No differences in blood loss were noticed. Continuous cold flow device in the acute postoperative setting after TKA did not show superiority in reducing edema, pain, and blood loss, compared with traditional icing regimen. Thus, due to the costs, it should be reserved to selected cases.


2021 ◽  
Author(s):  
Shih-Hsiang Yen ◽  
Po-Chun Lin ◽  
Jun-Wen Wang

Abstract BackgroundThere is limited information regarding the blood-conservation effect of combined topical tranexamic acid (TXA) and thrombin-based hemostatic matrix (TBHM) in total knee arthroplasty (TKA). This study is to evaluate whether there is synergic effect of combined use of TXA and TBHM to reduce blood loss during TKA.Material and MethodsSixty-nine patients (69 knees) who underwent primary TKA were randomly assigned into a TXA group (n = 34), who received intra-articular administration of 3g of TXA in 60mL saline, and a TXA + TBHM group (n = 35), who received intra-articular TBHM and TXA (3g) in 60mL saline after TKA. The primary outcomes were total blood loss (TBL) and postoperative hemoglobin (Hb) level. Secondary outcomes included the transfusion rate and the incidence of venous thromboembolism (VTE).ResultsThe mean TBL in the TXA + TBHM group was 678 ± 203mL , which was similar to that in the TXA only group at 733 ± 217mL (p= 0.276). There were no differences in the postoperative Hb level between the two groups. The transfusion rate was similar in the TXA + TBHM group and the TXA only group (2.9% versus 0%, p= 0.242). No patients in either group developed VTE within 3 months.ConclusionsOur prospective randomized controlled study did not show a synergic blood-conservation effect of combined use of topical TBHM and TXA in patients undergoing TKA. Further investigation with a larger sample size may be required.Trial registration: ClinicalTrials.gov, NCT03328832. Registered Oct 30 2017, http://clinicaltrials.gov/ct/show/NCT03328832?order=1


2021 ◽  
Vol 5 (3) ◽  
Author(s):  
Yen SH ◽  
◽  
Lin PC ◽  
Lu YD ◽  
Wang JW ◽  
...  

Background: There is limited information regarding the blood-conservation effect of combined topical Tranexamic Acid (TXA) and Thrombin-Based Hemostatic Matrix (TBHM) in Total Knee Arthroplasty (TKA). This study is to evaluate whether there is synergic effect of combined use of TXA and TBHM to reduce blood loss during TKA. Materials and Methods: Sixty-nine patients (69 knees) who underwent primary TKA were randomly assigned into a TXA group (n=34), who received intra-articular administration of 3g of TXA in 60mL saline, and a TXA + TBHM group (n=35), who received intra-articular TBHM and TXA (3g) in 60mL saline after TKA. The primary outcomes were Total Blood Loss (TBL) and postoperative Hemoglobin (Hb) level. Secondary outcomes included the transfusion rate and the incidence of Venous Thromboembolism (VTE). Results: The mean TBL in the TXA + TBHM group was 678 ± 203 mL , which was similar to that in the TXA only group at 733 ± 217 mL (p=0.276). There were no differences in the postoperative Hb level between the two groups. The transfusion rate was similar in the TXA + TBHM group and the TXA only group (2.9% versus 0%, p=0.242). No patients in either group developed VTE within 3 months. Conclusions: Our prospective randomized controlled study did not show a synergic blood-conservation effect of combined use of topical TBHM and TXA in patients undergoing TKA. Further investigation with a larger sample size may be required.


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