Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE (original) (raw)
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Thrombosis journal, 2011
Patients undergoing elective total hip replacement (THR) surgery are at an increased risk for venous thromboembolic events (VTEs). Dalteparin and enoxaparin are recommended as thromboprophylaxis for at least 10 days in these patients. Even though both agents have proven clinical effectiveness through placebo controlled studies, there have been no head to head trials to assess comparative effectiveness. Indirect statistical techniques were used to compare safety and efficacy between dalteparin and enoxaparin following THR surgery. A literature search was conducted from January 1980 to November 2009 for randomized trials evaluating dalteparin or enoxaparin prophylaxis in THR patients. In trials where a common control was used (e.g. placebo), indirect statistical comparisons between dalteparin and enoxaparin were performed using meta regression analysis with active drug as the primary independent variable. A total of nine placebo controlled enoxaparin (n = 5) and dalteparin (n = 4) tri...
Archives of Orthopaedic and Trauma Surgery, 2006
Introduction: We compared the efficacy and safety of standard heparin to that of low molecular weight heparin (Enoxaparin) in 100 hip replacement patients. Materials and methods: A total of 100 patients who underwent total hip replacement surgery were randomised to receive a study medication. Enoxaparin was administered to 50 patients (prophylaxis with subcutaneous injection of 40 mg of Enoxaparin daily was initiated 12 h preoperatively), and heparin (subcutaneous standard heparin initiated 8 h preoperatively on a dose of 5,000 IU and continued to 15,000 IU per day in three equal dosages every 8 h) was given to 50 patients. Each treatment was continued until the patients were discharged from the hospital. They were made to undergo lower extremity duplex ultrasonography for deep vein thrombosis before discharge and discontinued from medication if no pathology was found. The primary parameter to determine the efficacy was the prevalence of venous thromboembolic disease. The primary parameter to determine safety was the prevalence of major bleeding. Results: Two patients in the heparin group developed DVT, which was detected by routine duplex ultrasonography at the end of hospitalisation, and two patients in the exoparine group were detected with late DVT during the postoperative period of 6 weeks. Seven patients had minor and major bleeding in both the groups. Six patients in the heparin group discontinued from medication because of hepatic, renal dysfunctions, and serious discharges from the wound. Conclusion: Enoxaparin is as safe and as effective as standard heparin in total hip replacement surgery.
Thrombosis and haemostasis, 1988
A double blind randomized trial comparing subcutaneous enoxaparin (40 mg once daily) with standard unfractionated calcium heparin administered at a dose of 5,000 units every 8 hours in patients undergoing elective hip replacement has been performed. Treatment regimens began 12 hours preoperatively with enoxaparin, 2 hours preoperatively with standard unfractionated calcium heparin, and were continued for 15 days or until discharge. Venography was performed in all patients. Two hundred thirty-seven patients were included in the study: 113 received unfractionated heparin and 124 received enoxaparin. The incidence of proximal deep vein thrombosis was reduced from 18.5% in the unfractionated heparin group to 7.5% in the enoxaparin group (p = 0.014), and the incidence of total deep vein thrombosis was similarly reduced from 25% to 12.5% (p = 0.03). There were two major bleeding episodes and one minor bleed in the enoxaparin group compared to two minor bleeds in the unfractionated heparin...
Drugs & Therapy Perspectives, 2018
Background Major orthopedic surgeries include total or partial hip replacement, total knee replacement and hip fracture surgeries. These surgeries are considered to have a high risk for the development of venous thromboembolism (VTE). Objective This study was carried out to compare the clinical outcomes of aspirin (acetylsalicylic acid) and enoxaparin as thromboprophylaxis agents following major orthopedic surgery. Methods A prospective cohort study was conducted at one tertiary hospital in Amman, Jordan, between October 2014 and March 2015. One hundred and seventy patients were enrolled in the study after completion of the informed consent form. A follow-up period of up to 35 days was started immediately after the surgery date. According to surgeon experience and patients' risk factors, extended VTE prophylaxis was prescribed as enoxaparin 40 mg daily in 31.8% of patients (54/170) and as aspirin 325 mg daily in 68.2% of patients (116/170). Results Compliance with treatment was significantly higher with aspirin than with enoxaparin (97.4 vs. 75.9% of patients; p = 0.003). Significantly more enoxaparin than aspirin recipients experienced symptomatic VTE (16.7 vs. 5.2%; p = 0.014) and had bleeding (11.1 vs. 2.5%; p = 0.018). Conclusion Aspirin represents a safe and effective choice for extended VTE prophylactic in low-risk patients, as it is effective (for a mean duration of 1 month), safe, associated with high compliance rates, and is less expensive than other options.
Thrombosis Journal, 2015
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. Trial registration: ClinicalTrials.gov identifier # NCT00767559 FDA IND: 103,716
British Journal of Surgery, 1994
Deep vein thrombosis @VT) is a common complication in ness and cost were combined in an economic evaluation of patients undergoing elective hip surgery. Because of the the two regimens. It was found that prophylaxis with associated risk of pulmonary embolism, prophylaxis with enoxaparin would be expected to lead to a net saving of €20 standard (unfractionated) heparin is becoming increasingly per patient. The economic results are sensitive to the costs important. Recent clinical trials have shown a low of enoxaparin, the costs of drug administration and the molecular weight form of heparin, enoxaparin, to be more probability of false clinical diagnosis of DVT or pulmonary effective than standard heparin in preventing DVT, but the embolism. new drug is also more expensive. Data on clinical effective-Deep vein thrombosis (DVT) is common in patients undergoing elective hip surgery; in the absence of prophylaxis approximately 40-50 per cent of patients will develop the complication. Although in itself DVT is not a significant threat to life, it is the source of over 90 per cent of 2 1 Higson N. Auditing tests.
Biomedical Research and Therapy, 2021
Introduction: Our research aims to evaluate the effectiveness of thromboprophylaxis using enoxaparin in patients undergoing hip replacement. Methods: A retrospective cohort study was conducted based on medical records of patients aged 40 years and older undergoing hip replacement. Exclusion criteria included patients who had used anticoagulants to prevent other diseases, patients with a history of chronic renal failure, liver failure, cancer or allergy to anticoagulants, and patients with indicated mechanical prophylaxis. In our study, 65 patients were randomized into 2 groups - the control group and the venous thromboembolism (VTE) prophylaxis group (receiving subcutaneous enoxaparin 40 mg daily for 7 - 14 days). Preventive effectiveness was evaluated based on the comparison of VTE incidence after surgery between the groups. Results: In our study, most of the patients were over 60 years old (79.2%). No case of pulmonary embolism was recorded. There were 11 patients in the control g...
BMJ Open, 2019
IntroductionVenous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.Methods and analysisThis is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85–150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting...
JAMA
ImportanceThere remains a lack of randomized trials investigating aspirin monotherapy for symptomatic venous thromboembolism (VTE) prophylaxis following total hip arthroplasty (THA) or total knee arthroplasty (TKA).ObjectiveTo determine whether aspirin was noninferior to enoxaparin in preventing symptomatic VTE after THA or TKA.Design, Setting, and ParticipantsCluster-randomized, crossover, registry-nested trial across 31 hospitals in Australia. Clusters were hospitals performing greater than 250 THA or TKA procedures annually. Patients (aged ≥18 years) undergoing hip or knee arthroplasty procedures were enrolled at each hospital. Patients receiving preoperative anticoagulation or who had a medical contraindication to either study drug were excluded. A total of 9711 eligible patients were enrolled (5675 in the aspirin group and 4036 in the enoxaparin group) between April 20, 2019, and December 18, 2020. Final follow-up occurred on August 14, 2021.InterventionsHospitals were randomiz...