Efficacy and safety of Fondaparinux for prevention of venous thromboembolism after abdominal surgery.
Ontology highlight
ABSTRACT:
DISEASE(S): Colorectal Cancer
PROVIDER: 2622492 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
Similar Datasets
Project description:Interventions: Start IPC + Enoxaparin in 24-48 hour after surgery and continue to 4weeks
Perform U/S DVT both at 5-7 day after operation,Start only IPC until fully ambulation
Perform U/S DVT both at 5-7 day after operation;Prevention,Prevention;IPC + Enoxaparin,IPC only
Primary outcome(s): DVT 5-7 day after operation Yes/No (Ultrasound),DVT 1 month Yes/No (ultrasound)
| 94884 | ecrin-mdr-crc
Project description:BackgroundAbdominal obesity has been shown to be a superior measure over overall obesity for detecting cardiovascular risk.ObjectiveWe conducted this study to compare the effects of overall and abdominal obesity on venous thromboembolism (VTE) and to calculate population attributable fraction for obesity for VTE.MethodsBody mass index (BMI) and waist circumference (WC) were used to represent overall and abdominal obesity, respectively. In the cohort study, we included 74317 Swedish adults with anthropometric measures in 1997 and of whom 4332 were diagnosed with VTE until the end of 2017. A Mendelian randomization study was conducted to investigate causal associations of BMI, WC, and WC adjusted for BMI with VTE using data from FinnGen and UK Biobank study. Population attributable fraction was calculated for overall and abdominal obesity for VTE.ResultsIn the cohort study, there were dose-response associations of BMI and WC with VTE. The association between BMI and VTE was attenuated largely after adjusting for WC. Among individuals with normal BMI, participants with substantially increased WC had 53% higher (hazard ratio 1.53; 95% confidence interval, 1.28, 1.81) risk of VTE compared to those with normal WC. The causality of the association of WC adjusted for BMI with VTE was confirmed in Mendelian randomization analysis. The estimated population-attributable risk due to elevated BMI and WC were 12.4% (8.4%, 16.5%) and 23.7% (18.1%, 29.4%), respectively.ConclusionsWC might be a preferable indicator linking obesity to VTE. A large proportion of VTE cases can be prevented if the population maintained a healthy BMI and WC.
| S-EPMC7898626 | biostudies-literature
Project description:Recurrent venous thromboembolism (VTE) occurs infrequently following a provoked event but occurs in up to 30% of individuals following an initial unprovoked event. We studied 134 patients with VTE separated into 3 groups: (1) ‘low-risk’ patients had ≥1 provoked VTE; (2) ‘moderate-risk’ patients had no more than 1 unprovoked VTE; (3) ‘high-risk’ patients had ≥2 unprovoked VTE. 44 individuals with no history of VTE were enrolled as healthy controls. Consented individuals were enrolled at 4 medical centers in the US. Total RNA from whole blood was isolated and hybridized to Illumina HT-12 V4 Beadchips to assay whole genome expression. Using class prediction analysis, we distinguished high-risk patients from healthy controls with good receiver operating curve characteristics (AUC=0.88). We also distinguished high-risk from low-risk individuals, moderate-risk individuals from healthy controls, and low-risk individuals from healthy controls with AUC’s of 0.72, 0.77 and 0.72, respectively. Using differential expression analysis, we identified genes relevant to coagulation, immune response and vascular biology, such as SELP and CD46, which were differentially expressed in at least two comparisons. Neither approach distinguished the moderate-risk patients from the high-risk or low-risk groups. Gene expression profiles may provide insights into biological mechanisms associated with patients at risk for recurrent VTE. Prospective studies are needed to validate these findings.
2015-11-23 | GSE48000 | GEO
Project description:Interventions: The edoxaban (Lixiana) is orally administered as a once-daily dosing within three days before enrollment. The once-daily starting dose is 60mg.For patients with one or more factors that increase the risk of bleeding, such as renal impairment (CrCl 15-50mL.min), low body weight (under 60 kg), concomitant use of P-gp inhibitors (e.g. cyclosporine, dronedarone, ketoconazole, erythromycin), the dose is reduced by half.
Primary outcome(s): Incidence of major bleeding and clinically relevant non-major bleeding during 3 months after enrollment. Major bleeding events included those that were fatal; occurred in a critical area or organ (eg, intracranial); or caused a fall in hemoglobin of 2 g/dL or more or led to a transfusion of 2 or more units of whole blood or red cells. All non-major bleeding events that required any medical or surgical intervention were classified as clinically relevant non-major bleeding.
Study Design: Single arm Non-randomized
| 2643717 | ecrin-mdr-crc
Project description:Recurrent venous thromboembolism (VTE) occurs infrequently following a provoked event but occurs in up to 30% of individuals following an initial unprovoked event. We studied 134 patients with VTE separated into 3 groups: (1) âlow-riskâ patients had â¥1 provoked VTE; (2) âmoderate-riskâ patients had no more than 1 unprovoked VTE; (3) âhigh-riskâ patients had â¥2 unprovoked VTE. 44 individuals with no history of VTE were enrolled as healthy controls. Consented individuals were enrolled at 4 medical centers in the US. Total RNA from whole blood was isolated and hybridized to Illumina HT-12 V4 Beadchips to assay whole genome expression. Using class prediction analysis, we distinguished high-risk patients from healthy controls with good receiver operating curve characteristics (AUC=0.88). We also distinguished high-risk from low-risk individuals, moderate-risk individuals from healthy controls, and low-risk individuals from healthy controls with AUCâs of 0.72, 0.77 and 0.72, respectively. Using differential expression analysis, we identified genes relevant to coagulation, immune response and vascular biology, such as SELP and CD46, which were differentially expressed in at least two comparisons. Neither approach distinguished the moderate-risk patients from the high-risk or low-risk groups. Gene expression profiles may provide insights into biological mechanisms associated with patients at risk for recurrent VTE. Prospective studies are needed to validate these findings. This study includes a total of 218 samples/individuals (in 5 groups; APS, high-risk VTE, moderate-risk VTE, low-risk VTE and healthy-controls). Samples in which the percent of probes present was 15% or less (n=51) were excluded leaving 167 samples. The data for these 167 samples were normalized together. However, this record represents the 132 individual samples in the following groups; high-risk (n=40); moderate-risk (n=33); low-risk (n=34); and healthy controls (n=25). The 35 samples in APS group are represented in GSE48001.
2015-11-23 | E-GEOD-48000 | biostudies-arrayexpress
Project description: Not available
| S-EPMC8075715 | biostudies-literature
Project description:Anticoagulant drugs have an essential role in the prevention and treatment of thromboembolic diseases. Currently available anticoagulants substantially reduce the incidence of thromboembolic events in a number of clinical conditions. However, these agents have limitations that strengthen the case for the development of new anticoagulants. An ideal anticoagulant should be at least as effective as those currently in use, as well as safe, simple to use, and widely applicable.The majority of new anticoagulants currently under investigation are small molecules with a selective and direct anti-Xa or antithrombin action, allowing oral administration in fixed doses. These new agents are in different phases of clinical development. The anti-Xa agent rivaroxaban and the antithrombin agent dabigatran are already available for the prophylaxis of venous thromboembolism in some countries. Apixaban is in an advanced phase of clinical development and several anti-Xa agents are currently approaching phase III clinical trials. Promising results in terms of efficacy and safety profiles have been obtained with these agents in different clinical conditions. Differences in pharmacokinetics and pharmacodynamics could offer the potential for individualized anticoagulant therapies in the near future.
| S-EPMC2880336 | biostudies-literature
Project description: Not available
| S-EPMC6486093 | biostudies-literature
Project description:Patients with cancer who develop venous thromboembolism (VTE) are at elevated risk for recurrent thrombotic events, even during anticoagulant therapy. The clinical picture is further complicated because these patients are also at increased risk of bleeding while on anticoagulants. In general, there are four key goals of treatment for VTE: preventing fatal pulmonary embolism (PE); reducing short-term morbidities associated with acute leg or lung thrombus; preventing recurrent VTE; and preventing the long-term sequelae of VTE (e.g., post-thrombotic syndrome and chronic thromboembolic pulmonary hypertension). A fifth goal - minimising the risk for bleeding while on anticoagulation - is particularly warranted in patients with cancer. Traditionally, pharmacological treatment of VTE has two phases, with the transition between phases marked by a switch from a rapid-acting, parenterally administered anticoagulant (such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), or fondaparinux) to an oral vitamin K antagonist (e.g., warfarin). Recent clinical trials of established agents and the advent of new pharmacological options are changing this paradigm. Low-molecular-weight heparin continued for 6 months is more effective than warfarin in the secondary prevention of VTE in cancer patients without increasing the risk of bleeding and is now the preferred treatment option. Given the impact of VTE on short-term and long-term outcomes in patients with cancer, a group of health-care providers based in the United Kingdom gathered in London in 2009 to discuss recent data on cancer-associated thrombosis and to evaluate how these recommendations can be integrated or translated into UK clinical practice. This article, which is the third of four articles covering key topics in cancer thrombosis, focuses on treatment and secondary prevention of VTE in cancer patients.
| S-EPMC3317403 | biostudies-other
Project description:PurposeVenous thromboembolism (VTE) after bariatric surgery is a significant cause of morbidity and mortality. Current modalities of thromboprophylaxis include subcutaneous injection of unfractionated or low-molecular-weight heparin (LMWH), pneumatic compression, elastic stockings, and inferior vena cava filters. Despite universal agreement on the need for thromboprophylaxis, no clear consensus has been reached regarding the best regimen and treatment duration of bariatric surgery.MethodsFrom April, 2009 to December, 2011, we performed 200 bariatric surgery (191 with primary intent, 9 with revisional intent). There was no history of VTE prior to surgery. Clexane therapy was done with 4000 U SQ once daily for 2 weeks to the day before surgery. Development of VTE was assessed by direct interview, physical examination in out-patient clinic, and phone calls to patients for history taking if needed. The history taking was presented in questionnaire format. The patients were asked to state their symptoms of VTE by answering the questionnaire. The patients were followed up for a minimum of 6 months after surgery to determine the incidence of clinical VTE.ResultsTwo-week Clexane therapy was completed in 193 patients. Clexane was stopped in 5 due to surgical related complications (4 bleeding, 1 reoperation due to leak), in 2 due to Clexane related complications (1 epistaxis, 1 metrorrhagia). Follow-up of out-patient clinic were 68%, those who could follow up by telephone were 89%. There was no evidence of VTE.ConclusionA 2-week VTE prophylaxis regimen using LMWH is simple, effective and associated with a low incidence of complications.
| S-EPMC3641370 | biostudies-literature