OBTAIN E: outcome benefits of tranexamic acid in hip arthroplasty with enoxaparin: a randomised double-blinded controlled trial

2018 ◽  
Vol 29 (3) ◽  
pp. 239-244 ◽  
Author(s):  
Andrew Fraval ◽  
Sam Duncan ◽  
Theresa Murray ◽  
Jeremy Duggan ◽  
Oren Tirosh ◽  
...  
Keyword(s):  
Length Of Stay ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Hip Arthroplasty ◽  
Anterior Approach ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Control Group ◽  
Thigh Swelling ◽  
Double Blinded

Background: We examined the blood conserving effect of tranexamic acid in total hip arthroplasty using the direct anterior approach with enoxaparin as deep vein thrombosis (DVT) chemoprophylaxis, and whether this translates to an effect on functional outcomes in the perioperative period. We also compare the effect of aspirin and enoxaparin as DVT chemoprophylactic agents. Methods: We conducted a single-centre randomised, double-blinded, placebo-controlled trial. 105 patients were randomised to receive either tranexamic acid or an equivalent volume of normal saline with enoxaparin used as DVT chemoprophylaxis. The primary outcome measure was thigh swelling. Blood loss and the incidence of blood transfusions was also recorded. Secondary outcome measures including postoperative functional scores and mobility, pain scores and length of stay. We also compared and pooled the results of a previous study with the same study intervention methodology which used aspirin as DVT chemoprophylaxis instead of enoxaparin. Results: There were no statistically significant differences between the primary outcome of thigh swelling. There was significantly less intraoperative blood loss observed in the tranexamic acid (TXA) group (0.510 L, SD 0.210) compared with the control group (0.698, SD 0.301) ( p < 0.001). The estimated blood loss was also significantly less in the TXA group (1.130 L, SD 0.311) compared with the control group (1.48 L, SD 0.510) ( p < 0.001). Pooled data of both consecutive trials showed there was a statistically significant reduction in length of stay for those that received TXA (3.72 days, SD 0.83 versus 4.24 days, SD 0.97, p < 0.001). There was also a statistically significant increased risk of a transfusion in the control group as compared those that received TXA (OR 5.5, 1.188 to 25.449, p = 0.029). There was no difference in blood loss between DVT chemoprophylactic agents. Interpretation: TXA is an effective agent in reducing blood loss in THR using the anterior approach and was not affected by choice of DVT chemoprophylaxis. Patients who received TXA had fewer transfusions and a reduction in their length of stay. The blood conserving effect of TXA was not associated with improved postoperative recovery across the measures of pain and mobility. Clinical trials registration: ANZCTR number: ACTRN12616000606482.

scholarly journals Less Blood Loss With Tranexamic Acid in Primary Total Hip Arthroplasty Using the Direct Anterior Approach: a One-center Retrospective Observational Study

2021 ◽  
Author(s):  
Xian-Ren Zhu ◽  
Lei Wang ◽  
Hong-Wei Li ◽  
Guo-Chun Zha
Keyword(s):  
Total Hip Arthroplasty ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Hip Arthroplasty ◽  
Anterior Approach ◽  
Direct Anterior Approach ◽  
Harris Hip Score ◽  
Control Group ◽  
Transfusion Rate ◽  
Total Hip

Abstract Background: It is still not known whether tranexamic acid is beneficial for the minimally invasive surgical approach to total hip arthroplasty (THA). This study seeks to investigate the efficacy and safety of intravenous tranexamic acid (TXA) in primary THA via the direct anterior approach (DAA). Methods: We performed a retrospective analysis of prospectively collected data on 70 patients with non-traumatic avascular necrosis of the femoral head who underwent total hip arthroplasty (THA) via the DAA between October 2017 and October 2018. Patients were divided into two groups: TXA group (39 patients who did receive 1.5g TXA intravenously) and control group (31 patients who did not receive TXA). Patients were assessed by the operative time, postoperative hemoglobin (HB) drop, transfusion rate, postoperative length of hospital stays (LHS), deep vein thrombosis (DVT), and Harris hip score (HHS).Results: The total blood loss, hidden blood loss, and postoperative HB drop in the TXA group were significantly lower than those in the control group (p < 0.05). There was no statistical difference in terms of intraoperative blood loss, operation time, transfusion rate, postoperative LHS, HHS, and the incidence of DVT between the two groups (p > 0.05). Conclusion: TXA may be reduce perioperative blood loss and not increase complications, in THA via the DAA.

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

Effect of Multiple Doses of Oral Tranexamic Acid on Haemostasis and Inflammatory Reaction in Total Hip Arthroplasty: A Randomized Controlled Trial

2018 ◽  
Vol 119 (01) ◽  
pp. 092-103 ◽  
Author(s):  
Duan Wang ◽  
Yang Yang ◽  
Chuan He ◽  
Ze-Yu Luo ◽  
Fu-Xing Pei ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Blood Loss ◽  
Inflammatory Response ◽  
Tranexamic Acid ◽  
Hip Arthroplasty ◽  
Multiple Dose ◽  
Control Group ◽  
Total Hip ◽  
Estimated Blood Loss ◽  
Significant Difference

AbstractTranexamic acid (TXA) reduces surgical blood loss and alleviates inflammatory response in total hip arthroplasty. However, studies have not identified an optimal regimen. The objective of this study was to identify the most effective regimen of multiple-dose oral TXA in achieving maximum reduction of blood loss and inflammatory response based on pharmacokinetic recommendations. We prospectively studied four multiple-dose regimens (60 patients each) with control group (group A: matching placebo). The four multiple-dose regimens included: 2-g oral TXA 2 hours pre-operatively followed by 1-g oral TXA 3 hours post-operatively (group B), 2-g oral TXA followed by 1-g oral TXA 3 and 7 hours post-operatively (group C), 2-g oral TXA followed by 1-g oral TXA 3, 7 and 11 hours post-operatively (group D) and 2-g oral TXA followed by 1-g oral TXA 3, 7, 11 and 15 hours post-operatively (group E). The primary endpoint was estimated blood loss on post-operative day (POD) 3. Secondary endpoints were thromboelastographic parameters, inflammatory components, function recovery and adverse events. Groups D and E had significantly less blood loss on POD 3, with no significant difference between the two groups. Group E had the most prolonged haemostatic effect, and all thromboelastographic parameters remained within normal ranges. Group E had the lowest levels of inflammatory cytokines and the greatest range of motion. No thromboembolic complications were observed. The post-operative four-dose regimen brings about maximum efficacy in reducing blood loss, alleviating inflammatory response and improving analgaesia and immediate recovery.

A randomized, double-blind, placebo-controlled trial on the efficacy of tranexamic acid combined with rivaroxaban thromboprophylaxis in reducing blood loss after primary cementless total hip arthroplasty

2019 ◽  
Vol 101-B (2) ◽  
pp. 207-212 ◽  
Author(s):  
A. Clavé ◽  
R. Gérard ◽  
J. Lacroix ◽  
C. Baynat ◽  
M. Danguy des Déserts ◽  
...  
Keyword(s):  
Total Hip Arthroplasty ◽  
Blood Loss ◽  
Tranexamic Acid ◽  
Hip Arthroplasty ◽  
Posterior Approach ◽  
Controlled Trial ◽  
Thromboembolic Complications ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Total Hip

Aims Cementless primary total hip arthroplasty (THA) is associated with risks of bleeding and thromboembolism. Anticoagulants are effective as venous thromboprophylaxis, but with an increased risk of bleeding. Tranexamic acid (TXA) is an efficient antifibrinolytic agent, but the mode and timing of its administration remain controversial. This study aimed to determine whether two intravenous (IV) TXA regimens (a three-hour two-dose (short-TXA) and 11-hour four-dose (long-TXA)) were more effective than placebo in reducing perioperative real blood loss (RBL, between baseline and day 3 postoperatively) in patients undergoing THA who receive rivaroxaban as thromboprophylaxis. The secondary aim was to assess the non-inferiority of the reduction of blood loss of the short protocol versus the long protocol. Patients and Methods A multicentre, prospective, randomized, double-blind, placebo-controlled trial was undertaken involving 229 patients undergoing primary cementless THA using a posterior approach, whose extended rivaroxaban thromboprophylaxis started on the day of surgery. There were 98 male and 131 female patients, with a mean age of 65.5 years (32 to 91). The primary outcome, perioperative RBL, was evaluated at 72 hours postoperatively. The efficacy of short- and long-TXA protocols in the reduction of perioperative RBL was compared with a placebo group. Results TXA significantly reduced perioperative blood loss compared with placebo (p < 0.001); the mean differences were 525.3 ml (short-TXA vs placebo) and 550.1 ml (long-TXA vs placebo). No venous or arterial thromboembolic complications were reported. The upper boundary of the 95% confidence interval, when comparing short and long protocols, was below the pre-specified margin of non-inferiority (p = 0.027). Conclusion In patients undergoing primary cementless THA, using a posterior approach, who are treated with rivaroxaban for thromboembolic prophylaxis, short- and long-TXA IV protocols are significantly more effective than placebo in reducing perioperative RBL, without any thromboembolic complications. Non-inferiority of a short- versus a long-TXA protocol in reducing perioperative RBL was supported in a secondary analysis.

OBTAIN A: Outcome Benefits of Tranexamic Acid in Hip Arthroplasty. A Randomized Double-Blinded Controlled Trial

2017 ◽  
Vol 32 (5) ◽  
pp. 1516-1519 ◽  
Author(s):  
Andrew Fraval ◽  
Peter Effeney ◽  
Lena Fiddelaers ◽  
Belinda Smith ◽  
Ben Towell ◽  
...  
Keyword(s):  
Tranexamic Acid ◽  
Hip Arthroplasty ◽  
Controlled Trial ◽  
Double Blinded
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