Multiple intravenous tranexamic acid doses in total knee arthroplasty in patients with rheumatoid arthritis: a randomized controlled study

Abstract Background We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA). Methods For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50–75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1.5 g tranexamic acid after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) level decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay. Results The mean TBL, HBL, and maximum Hb level decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. The D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the groups (P > 0.05). Conclusion In patients with RA, three doses of postoperative IV-TXA further facilitated HBL and Hb level decrease without increasing the incidence of adverse events in a short period after TKA. Trial registration The trial was registered in the Chinese Clinical Trial Registry (ChiCTR1900025013).

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Multiple intravenous tranexamic acid doses in total knee arthroplasty in patients with rheumatoid arthritis: a randomized controlled study

10.21203/rs.3.rs-42566/v2 ◽

2020 ◽

Author(s):

Bing-xin Kang ◽

Hui Xu ◽

Chen-xin Gao ◽

Sheng Zhong ◽

Jing Zhang ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Clinical Trial ◽

Total Knee Arthroplasty ◽

Blood Loss ◽

Tranexamic Acid ◽

Randomized Controlled ◽

Group A ◽

Total Knee ◽

Group B ◽

D Dimer

Abstract Background: To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who have undergone primary unilateral total knee arthroplasty (TKA).Methods: For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants aged 50–75 years, with RA who underwent unilateral primary TKA were recruited. The patients received one dose of 1g IV-TXA was 10 min before skin incision, followed by articular injection 1.5 g TXA after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay.Results: Between September 2019 and May 2020, 104 participants were randomized, but 7 were lost to follow-up. The mean TBL, HBL, and maximum Hb decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. D-dimer level was lower in group B than in group A on postoperative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the two groups (P > 0.05). Conclusion: In patients with RA, three doses of postoperative IV-TXA further enabled HBL and Hb decrease without increasing the incidence of adverse events in a short period of time after TKA.Trial registration: The trial was registered in Chinese Clinical Trial Registry (ChiCTR1900025013).

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Multiple-Dose Intravenous Tranexamic Acid in Total Knee Arthroplasty in Patients with Rheumatoid Arthritis: A Randomized Controlled Study

10.21203/rs.3.rs-42566/v1 ◽

2020 ◽

Author(s):

Bing-xin Kang ◽

Hui Xu ◽

Chen-xin Gao ◽

Sheng Zhong ◽

Jing Zhang ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Total Knee Arthroplasty ◽

Blood Loss ◽

Tranexamic Acid ◽

Knee Arthroplasty ◽

Randomized Controlled ◽

Group A ◽

Total Knee ◽

Group B ◽

D Dimer

Abstract Background: To identify the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who underwent primary unilateral total knee arthroplasty (TKA).Methods: In this single-center, single-blind randomized controlled clinical trial, ten male and 87 female participants aged 50–75 years, with RA who underwent unilateral primary TKA were randomly assigned (1:1) to receive a single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total red blood cell loss (TBL), hidden red blood loss (HBL) and maximum hemoglobin (Hb) drop. Secondary outcomes were transfusion rate and levels of D-dimer. All parameters were measured post-operatively during inpatient hospital stay.Results: Between September 2019 and May 2020, 104 participants were randomized. 7 were lost follow-up. Mean TBL, HBL, and maximum Hb drop in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in groups A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. D-dimer level was lower in group B than in group A on post-operative day 1 (P < 0.001), and the incidence of thromboembolic events was similar between the two groups (P > 0.05). Conclusion: Three doses of post-operative IV-TXA could further reduced blood loss, maximum Hb drop, and diminished the postoperative fibrinolytic responses without increasing the risk of complications.Trial registration: The trial was registered in Chinese Clinical Trial Registry (ChiCTR1900025013).Name of the registry: Clinical observation of multiple dose use of tranexamic acid in patients with rheumatoid arthritis after total knee arthroplasty. Prospective registration, ChiCTR1900025013. Registered 7 August 2019, http://www.chictr.org.cn/showproj.aspx?proj=41375

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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

BMC Musculoskeletal Disorders ◽

10.1186/s12891-019-2885-5 ◽

2019 ◽

Vol 20 (1) ◽

Cited By ~ 2

Author(s):

Hao-Yang Wang ◽

Liu Wang ◽

Ze-Yu Luo ◽

Duan Wang ◽

Xin Tang ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Blood Loss ◽

Tranexamic Acid ◽

Knee Arthroplasty ◽

Total Blood ◽

Significant Difference ◽

Group A ◽

Total Knee ◽

Group B

Abstract 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).

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Multiple-dose tranexamic acid for perioperative blood loss in total knee arthroplasty in patients with rheumatoid arthritis：a single-blinded, randomised, parallel-controlled study protocol in China

BMJ Open ◽

10.1136/bmjopen-2019-034431 ◽

2020 ◽

Vol 10 (8) ◽

pp. e034431

Author(s):

Bing-Xin Kang ◽

Hui Xu ◽

Chen-Xin Gao ◽

Sheng Zhong ◽

Jing Zhang ◽

...

Keyword(s):

Total Knee Arthroplasty ◽

Blood Loss ◽

Tranexamic Acid ◽

Intravenous Injection ◽

Knee Arthroplasty ◽

Multiple Dose ◽

Controlled Study ◽

Group A ◽

Total Knee ◽

Group B

IntroductionThis clinical trial is designed to evaluate the effect of multiple-dose tranexamic acid (TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA).Methods and analysisA randomised, single-blinded, parallel-controlled study will be designed. Patients with RA (age 50–75 years) undergoing unilateral primary end-stage total knee arthroplasty will be randomly divided into group A or group B. Group A will be treated with one dose of TXA (1 g; intravenous injection 3 hours postsurgery) and group B with three doses (1 g; intravenous injection at 3, 6 and 12 hours postsurgery) after surgery. The primary outcomes will be evaluated with blood loss, maximum haemoglobin drop and transfusion rate. The secondary outcomes will be evaluated with knee function and complications.Ethics and disseminationThe Shanghai Guanghua Hospital of Integrated Traditional Chinese Medicine and Western Medicine Ethics Committee approved in this study in July 2019. Informed consent will be obtained from all participants. Results of the trial will be published in the Dryad and repository in a peer-reviewed journal. Additionally, deidentified data collected and analysed for this study will be available for review from the corresponding author on reasonable request.Trial registration numberChiCTR1900025013.

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Clinical effectiveness of 3 days preoperative treatment with recombinant human erythropoietin in total knee arthroplasty surgery: a clinical trial

QJM ◽

10.1093/qjmed/hcz261 ◽

2019 ◽

Vol 113 (4) ◽

pp. 245-252

Author(s):

S -L Cao ◽

Y Ren ◽

Z Li ◽

J Lin ◽

X -S Weng ◽

...

Keyword(s):

Clinical Trial ◽

Total Knee Arthroplasty ◽

Blood Loss ◽

Knee Arthroplasty ◽

Recombinant Human Erythropoietin ◽

Iron Supplement ◽

Human Erythropoietin ◽

Group A ◽

Total Knee ◽

Group B

Abstract Aims The purpose of study is to evaluate the effect and complication of preoperative short-term daily recombinant human erythropoietin (rhEPO) treatment for blood-saving in patients undergoing unilateral primary total knee arthroplasty (TKA). Methods This three-arm randomized clinical trial compared three different rhEPO-based treatment protocols for unilateral primary TKA. Group A: application of daily doses of rhEPO combined with iron supplement starting 3 days before surgery; Group B: application of daily doses of rhEPO combined with iron supplement starting the day of surgery; Group C: iron supplement alone. Perioperative hemoglobin (Hb) level gaps, total perioperative blood loss, reticulocyte levels and treatment-related complications were studied. Results A total of 102 patients were included (35, 35 and 32 patients in Groups A, B and C, respectively). Total blood loss (TBL) in Groups A, B and C was 490.84, 806.76 and 924.21 ml, respectively. Patients in Group A had a significant lower TBL than Groups B and C (A vs. B: P = 0.010; A vs. C: P < 0.001). There was no difference as for TBL between Groups B and C (P = 0.377). Group A patients had significant smaller Hb decline than Group C on the third and fifth postoperative day (P = 0.049, P = 0.037), as well as than Group B on the fifth postoperative day (P = 0.048). There was no difference as for Hb decline between Groups B and C. No difference was shown in levels of inflammatory biomarkers or blood-saving protocol-related complications among three groups. Conclusions Daily dose of rhEPO combined with iron supplement administered 3 days before TKA procedures could significantly decrease perioperative blood loss and improve postoperative Hb levels, without significantly elevating risks of complication, when compared with admission of rhEPO on the day of surgery and iron supplement alone. Preoperative daily rhEPO treatment could be a more effective blood-saving protocol in TKA procedures.

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