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Auteurs Hu KZ , Sun HY , Sui C
Journal International journal of clinical pharmacology and therapeutics
Year 2017
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OBJECTIVE: Our study is aimed to explore effects of five treatment regimens on blood loss and blood transfusion rate in total knee arthroplasty (TKA) patients. METHODS: 191 TKA patients were divided into the rivaroxaban, nadroparin, and tranexamic acid groups (n = 37 each) as well as into the affected-limb-position and tourniquet group (n = 40 each). A 3-month follow-up after operation was needed for all patients. The total blood loss, hidden blood loss, and dominant blood loss were recorded, and hemoglobin and red blood cell changes, pain and knee swelling degrees, hospital for special surgery (HSS), and American knee society (KSS) knee scores were observed. RESULTS: When compared with the rivaroxaban, nadroparin, and tourniquet groups, TKA patients' dominant blood loss, hidden blood loss, total blood loss, rate and volume of blood transfusion in the tranexamic acid and affected-limb-position groups were significantly decreased. While 7 days after operation, the hemoglobin and red blood cells in the tranexamic acid and affected-limb-position groups were significantly increased. At 1 month and 3 months after operation, when compared with the rivaroxaban, nadroparin, and tourniquet groups, the HSS and KSS scores in the tranexamic acid and affected-limb-position groups were all increased. In comparison with the rivaroxaban, nadroparin, and tourniquet groups, the D-Dimers after operation in the tranexamic acid and affected-limb-position groups were significantly lower. CONCLUSION: These results demonstrated that for TKA patients, the tranexamic acid and affected-limb-position could obviously reduce the blood loss and blood transfusion rate.
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Journal Journal of the Medical Association of Thailand = Chotmaihet thangphaet
Year 2017
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BACKGROUND: There has been some controversy about routine use of thromboprophylaxis after total knee arthroplasty (TKA) in Asian patients. OBJECTIVE: To compare the efficacy and safety of enoxaparin in preventing venous thromboembolic diseases after TKA in Asian patients. MATERIAL AND METHOD: We randomized 50 patients undergoing primary TKA into two equal groups, 25 patients received once daily subcutaneous enoxaparin injections as thromboprophylaxis and 25 control patients did not receive anticoagulation. The primary outcome was deep vein thrombosis (DVT) identified by color Doppler ultrasonography and/or pulmonary embolism (PE). All significant bleeding complications were recorded. RESULTS: Deep vein thrombosis occurred in only one patient in the control group (4%) and in none in the enoxaparin group (0%, p = 0.31). No patient in both groups had clinical signs of PE. No patient had significant bleeding complications. One patient in enoxaparin group had a minor bleeding complication (4%) and also a surgical wound complication. CONCLUSION: We concluded that the incidence of thromboembolic diseases after primary TKA in Thai patients is very low. Enoxaparin had no significant benefit in reducing venous thromboembolic complications after TKA in Asian patients, however it is safe in term of bleeding complications. We do not recommend routine use of enoxaparin as thromboprophylaxis after TKA in Asian patients.

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Journal Asian journal of surgery
Year 2017
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OBJECTIVE: In the Re-NOVATE II study, oral dabigatran provided thromboprophylaxis after total hip arthroplasty and improved compliance postdischarge in a global population. This article aims to identify trends (if any) in the Indian population. METHODS: In this prospective, double-blind, double-dummy study, patients scheduled for primary, unilateral, elective total hip arthroplasty were randomized to 220 mg oral dabigatran once daily, starting with a 110 mg half-dose, 1-4 hours after surgery, or subcutaneous enoxaparin 40 mg once daily, starting the evening before surgery. Each group received a placebo of the other study drug. The primary efficacy outcome was the composite of total venous thromboembolism (VTE) and all-cause mortality. Secondary outcome measures were composite of major VTE and VTE-related mortality during the treatment period. The major safety outcome was incidence of bleeding events. RESULTS: Of the 179 Indian patients randomized, 91 received oral dabigatran and 88 received subcutaneous enoxaparin for 28-35 days. Total VTE and all-cause mortality occurred in 18.7% of patients in the dabigatran group and 13.7% in the enoxaparin group [odds ratio = 1.4 (95% confidence interval 0.6, 3.5)]. Major VTE and VTE-related mortality was numerically lower in the dabigatran group (7.9%) compared with the enoxaparin group (9.9%). Safety outcomes were comparable between both groups. CONCLUSION: Dabigatran is an effective oral alternative to enoxaparin for thromboprophylaxis as demonstrated by the RE-NOVATE II study global results. Data analyzed in Indian patients indicate comparable effects of dabigatran etexilate for major efficacy and safety outcomes.

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Journal Phlebology
Year 2016
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AIM: To investigate the potential role of a novel electrostimulation device in augmenting the femoral vein venous blood flow following total knee replacement surgery. MATERIAL AND METHODS: A total of 30 consecutive patients undergoing total knee replacement were allocated to receive either peroneal nerve electrostimulation plus low molecular weight heparin and below-knee compression stockings (Group 1, electrostimulation group, n = 15, mean age: 63.40 ± 5.91 years, male: female ratio 9:6) or low molecular weight heparin and below-knee compression stockings alone (Group 2, control group, n = 15, mean age: 63.86 ± 7.47 years, male: female ratio 8:7). Electrostimulation was performed for 1 h in every 4 h after the operation. Peak blood velocity in the femoral vein was evaluated with Duplex ultrasonongraphy in supine position. Presence of leg edema and calf diameter was also taken into consideration as outcome measures, which were recorded both before surgery and at the time of discharge from hospital. RESULTS: Postoperative peak blood flow velocity in the femoral vein was significantly higher in electrostimulation group compared to control group (17.46 ± 2.86 cm/s vs. 13.84 ± 3.58 cm/s, p < 0.02). Electrostimulation group achieved a significant increase in peak blood flow velocity in the femoral vein after the operation (mean increase 67.48 ± 17.38%, p < 0.001). CONCLUSION: Electrostimulation of the common peroneal nerve enhanced venous flow in the lower limb and may potentially be of use as a supplementary technique in deep venous prophylaxis following lower limb orthopedic operations.

Primary study

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Journal Medicine
Year 2016
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We conducted a randomized clinical trial to compare the effectiveness of the A-V Impulse System foot pump for reducing the incidence of deep-vein thrombosis (DVT) after total knee arthroplasty (TKA) in patients under edoxaban thromboprophylaxis. Patients undergoing primary TKA at our institution between September 2013 and March 2015 were enrolled after obtaining informed consent. The patients were randomized to use the foot pump (n = 58) and not to use the foot pump (n = 62). Both groups were given prophylactic edoxaban. Primary outcomes were any DVT as detected by bilateral ultrasonography up to postoperative day 10 (POD10) and pulmonary embolism (PE) up to POD28. The safety outcomes were bleeding and death of any cause up to POD28. Plasma D-dimer levels were measured before TKA and on POD10 after TKA. Immunoglobulin G (IgG)-class anti-PF4/heparin antibodies were measured using an IgG-specific enzyme-linked immunosorbent assay. The incidences of any DVT up to POD28 were 31.0% and 17.7% in patients with or without the foot pump, respectively. The incidences of major bleeding up to POD28 were 5.1% and 4.8% in patients with or without the foot pump, respectively. Foot pump use did not significantly reduce the incidence of DVTs in patients undergoing TKA under edoxaban thromboprophylaxis. Although seroconversion of anti-PF4/heparin antibodies was confirmed in one-fourth of patients, the seroconversion rates did not differ between patients with (20.7%) or without (25.8%) foot pump use. This study shows that the A-V Impulse system foot pump did not affect the incidence of DVT under edoxaban thromboprophylaxis in patients undergoing TKA. Seroconversion of anti-PF4/heparin antibodies was detected in a significant number of patients who underwent TKA under antithrombotic prophylaxis using edoxaban.

Primary study

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Auteurs Kim SM , Moon YW , Lim SJ , Kim DW , Park YS
Journal Thrombosis and haemostasis
Year 2016
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This prospective study was conducted to report the effect of oral factor Xa inhibitor and low-molecular-weight heparin (LMWH) on surgical complications following total hip arthroplasty (THA). The patients with an age < 60 years were randomly assigned to three groups (rivaroxaban, enoxaparin, and placebo) and the patients with an age ≥ 60 years were assigned to two groups (rivaroxaban and enoxaparin). All drug regimens started at 12 hours postoperatively and continued for two weeks after surgery. Primary measure outcome was major surgical wound complications defined as haematoma requiring any intervention, superficial wound infection, deep periprosthetic infection, and increased wound bleeding. Secondary measured outcome included minor surgical complications (swelling, drainage, erythema, and oozing), organ bleeding, and venous thromboembolic (VTE) events. A total of 184 patients aged < 60 years and 167 patients aged ≥ 60 years were included as the analysis population per group. Up to 14 days after surgery, the overall incidence of major surgical complications associated with thromboprophylaxis was 6.5 % (58/886). There were no significant differences in the rate of major surgical complications among all the three groups of the patients aged < 60 years and between two groups of the patients aged ≥ 60 years. For the patients aged < 60 years, wound oozing continued significantly longer in the pharmacological group than in the placebo group, but wound infection did not occur in any case. The VTE events were similar in all the groups.

Primary study

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Journal Thrombosis journal
Year 2015
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BACKGROUND: Deep vein thrombosis (DVT) and pulmonary emboli (PE), known together as venous thromboembolic (VTE) disease remain major complications following elective hip and knee surgery. This study compares three chemoprophylactic regimens for VTE following elective primary unilateral hip or knee replacement, one of which was designed to minimize risk of post-operative bleeding. METHODS: Patients were randomized and stratified for hip vs. knee to receive A: variable dose warfarin (first dose on the night preceding surgery with subsequent target INR 2.0-2.5), B: 2.5 mg fondaparinux daily starting 6-18 h postoperatively, or C: fixed 1.0 mg dose warfarin daily starting 7 days preoperatively. All treatments continued until bilateral leg venous ultrasound day 28 ± 2 or earlier upon a VTE event. The study examined primary endpoints including leg DVT, PE or death due to VTE and secondary endpoints including effects on D-dimer, estimated blood loss (EBL) at surgery and hemorrhagic complications. RESULTS: Three hundred fifty-five patients were randomized. None was lost to follow-up. Taking 1.0 mg warfarin for seven days preoperatively did not prolong the prothrombin time (PT). Two patients in Arm C had asymptomatic distal DVT. One major bleed occurred in Arm B and one in Arm C (ischemic colitis). Elevated d-dimer did not predict delayed VTE for one year. CONCLUSIONS: Fixed low dose warfarin started preoperatively is equivalent to two other standards of care under study (95 % CI: -0.0428, 0.0067 for both) as VTE prophylaxis for the patients having elective major joint replacement surgery.

Primary study

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Journal Journal of orthopaedics
Year 2015
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BACKGROUND: Thromboembolic disease (TED) after knee arthroplasty occurs infrequently in Iran. The aim of this study was to examine the incidence of TED in patients with osteo-arthritis undergoing knee replacement in Southern Iran while on prophylaxis. Materials &amp; methods: In a case series study from January to December 2012,100 consecutive total knee arthroplasty (TKA) candidates were evaluated for TED by clinical evaluation and Doppler sonography preoperatively and 2 months postoperatively and by clinical evaluation one year after surgery. The patients in this study randomly received either warfarin or enoxaparin prophylactically. RESULTS: A total of 77 women and 23 men with mean age of 67 years (52-82 years) entered the study. The average hemoglobin drop of 2.7 g with warfarin and 3.3 with enoxaparin was observed. No case of TED, pulmonary embolus (PE), major bleeding, post-thrombotic syndrome, or hemarthrosis was observed. CONCLUSION: No clinically significant DVT was found using either enoxaparin or warfarin prophylaxis after TKA in Southern Iran. Relatively excessive postoperative bleeding was observed, particularly with enoxaparin.

Primary study

Unclassified

Auteurs Kang J , Jiang X , Wu B
Journal Chinese medical journal
Year 2015
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BACKGROUND: Deep venous thrombosis (DVT) is a common complication of arthroplasty in old patients. We analyzed risk factors for lower-limb DVT after arthroplasty in patients aged over 70 years to determine controllable risk factors. METHODS: This was a retrospective study of 1,025 patients aged >70 years treated with knee arthroplasty at our hospital between January 2009 and December 2013. Of 1,025 patients, 175 had postoperative lower-limb DVT. We compared medical history, body mass index (BMI), ambulatory blood pressure, preoperative and postoperative fasting blood glucose (FBG), preoperative blood total cholesterol, triglyceride, high- and low-density lipoprotein cholesterol, and preoperative homocysteine (Hcy) between thrombus and non-thrombus groups. B-mode ultrasonography was used to detect lower-limb DVT before the operation and 7 days after the operation in all patients. Logistic regression analysis was used to determine risk factors for DVT. RESULTS: Incidence of diabetes (P = 0.014), BMI (P = 0.003), preoperative FBG (P = 0.004), postoperative FBG (P = 0.012), and preoperative Hcy (P < 0.001) were significantly higher in the thrombus group. A significantly greater proportion of patients in the non-thrombus group had early postoperative activity (P < 0.001) and used a foot pump (P < 0.001). Operative duration was significantly longer in the thrombus group (P = 0.012). Within the thrombus group, significantly more patients had bilateral than unilateral knee arthroplasty (P < 0.01). Multivariate logistic analysis revealed BMI, preoperative Hcy, postoperative FBG, long operative duration, bilateral knee arthroplasty, and time to the activity after the operation to be predictive factors of DVT. At 6-month follow-up of the thrombus group, 4.7% of patients had pulmonary embolism and 18.8% had recurrent DVT; there were no deaths. CONCLUSIONS: Obesity, inactivity after operation, elevated preoperative Hcy and postoperative FBG, long operative duration, and bilateral knee arthroplasty were risk factors for DVT in patients aged over 70 years.

Primary study

Unclassified

Auteurs Hu YP , D. , Shen Y , Chen X
Journal 中国组织工程研究与临床康复 (Chinese Journal of Tissue Engineering Research)
Year 2015
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BACKGROUND: After knee joint replacement, patients are often treated with Rivaroxaban and Enoxaparin Sodium for postoperative anticoagulation, avoiding the formation of deep vein thrombosis in lower limbs. OBJECTIVE: To explore the application effects of different anticoagulant drugs in patients with knee joint replacement. METHODS: Ninety patients underwent knee joint replacement in Xiangya Second Hospital of Central South University from July 2011 to July 2014, were randomly divided into two groups, with 45 patients in each group. The experimental group was treated with Rivaroxaban, while the control group was treated with Enoxaparin. RESULTS AND CONCLUSION: Postoperative drainage volume, total blood transfusion, bleeding index, quantity of blood platelet, activated partial thromboplastin time, thrombin reduction time, whole blood viscosity, plasma viscosity, D-dimer coagulation index, HSS score at postoperative 2 weeks, average ecchymosis area, average thigh circumference, and average leg circumference were significantly better in the experimental group, than in the control group(P 0.05). The incidence of deep vein thrombosis of lower limbs in the experimental group was lower than that in the control group(P 0.05). Experimental findings indicate that, both Rivaroxaban and Enoxaparin can exert anticoagulation effect during the knee joint replacement, and Rivaroxaban is better.