Antiembolic stockings and pneumatic compression devices in a medical-surgical thromboprophylaxis trial
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SUBMITTER: Zytaruk N
PROVIDER: S-EPMC3061651 | biostudies-literature | 2011 Jan
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery.DesignOpen, multicentre, randomised, controlled, non-inferiority trial.SettingSeven National Health Service tertiary hospitals in the United Kingdom.Participants1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate.InterventionParticipants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS.Outcome measuresThe primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality.ResultsBetween May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior.ConclusionsFor patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery.Trial registrationISRCTN13911492.
| S-EPMC7219517 | biostudies-literature
Project description:BackgroundDeep vein thrombosis (DVT) is common in patients undergoing gynecological surgery. We aimed to investigate the preventive efficacy in DVT of graduated compression stockings (GCS) alone and in combination with intermittent pneumatic compression (GCS + IPC) after gynecological surgery.MethodsIn November 2022, studies on the use of GCS and GCS + IPC for the prevention of DVT after gynecological surgery were searched in seven databases. After literature screening and data extraction based on specific inclusion and exclusion criteria, preventive efficacies, including the risk of DVT and anticoagulation function, of GCS and GCS + IPC were compared. Finally, sensitivity analysis and Egger's test were performed to evaluate the stability of the meta-analysis.ResultsSix publications with moderate quality were included in this meta-analysis. The results showed that GCS + IPC significantly reduced DVT risk (P = 0.0002) and D-dimer levels (P = 0.0005) compared with GCS alone. Sensitivity analysis and Egger's test showed that the combined results of this study were stable and reliable.ConclusionsCompared with GCS alone, GCS + IPS showed a higher preventive efficacy against DVT in patients following gynecological surgery.
| S-EPMC11245769 | biostudies-literature
Project description:Venous malformations are one of the most common vascular anomalies. Our study aimed to investigate the effect of medical compression stockings of class I and II on the volume of venous malformations. Patients with venous malformations on upper or lower extremities were enrolled. They wore flat-knitted medical compression stockings of class I and II in a randomized order for four weeks each. Magnetic resonance imaging (MRI) and perometry were performed with and without wearing compression stockings. The 12-Item Short Form Survey (SF-12) questionnaire was performed before and after wearing compression stockings for four weeks each. A total of 18 patients completed the evaluations. Both compression classes showed a significant reduction of the volume of the venous malformations in the lesion itself based on MRI in comparison with baseline (both p < 0.001). Measurements taken with perometry did not reveal a significant difference in comparison to baseline (p = 0.09 and p = 0.22). The results of the SF-12 questionnaire demonstrated no significant differences before and after wearing the compression stockings of class I or class II for four weeks or between the two classes of compression therapy. Our results indicate that wearing medical compression stockings of both class I and class II significantly reduces the volume of venous malformation, without compromising the quality of life, while the effect of class II compression stockings on volume reduction was significantly better than that of class I.
| S-EPMC10094853 | biostudies-literature
Project description:Background Occupational edema is reported to occur in healthy individuals after working in a sitting or standing position for extensive periods of time. It can be associated with feelings of tiredness, heaviness of the legs, and pain. Three licensed medical devices were compared in their management of occupational edema. Subjects and Methods A total of 10 subjects were recruited from a clinical workspace. Right leg volume and great saphenous vein diameter was measured in the morning, and 6 hours later. On subsequent separate days, grade 2 graduated compression stockings (Active Compression Socks, Mediven, United Kingdom), geko (Firstkind Ltd, United Kingdom), and Revitive (Actegy Ltd, United Kingdom) were used bilaterally according to manufacturer's instructions. Results Leg volumes increased by median 41 mL (p < 0.05) with no intervention. Percentage increase in leg volume was found to be significantly reduced by stockings compared with control (-1.7%, p < 0.01), and were more effective than electrical devices. Changes in vein diameter poorly correlate with leg volume changes. Conclusion Occupational edema can occur over as little as 6 hours. All devices were well tolerated and reduced leg swelling. Stockings were the only device to significantly reduce leg swelling in this small trial.
| S-EPMC4870057 | biostudies-literature
Project description:Compression therapy is highly effective in the treatment of many venous diseases, including leg edema. However, its relevance in patients with peripheral arterial disease (PAD) or diabetes mellitus is critically discussed. The aim of the present study was to assess the influence of compression therapy on microperfusion and its safety in patients with PAD or diabetes mellitus. A prospective analysis of 94 consecutive patients (44 patients with diabetes, 45 patients with PAD and 5 healthy controls) undergoing medical compression therapy was performed. Microperfusion was assessed by a combined method of white light tissue spectrometry and laser Doppler flowmetry under medical compression therapy (classes I and II), in different body positions (supine, sitting, standing and elevated position of the leg) and at different locations (great toe, lateral ankle and calf). During the entire study, no compression-related adverse events occurred. Evaluation of microcirculation parameters (oxygen saturation of hemoglobin and flow) at the different locations and in sitting and standing positions (patients with diabetes and PAD) under compression therapy classes I and II revealed no tendency for reduced microperfusion in both groups. In contrast, in the elevated leg position, all mean perfusion values decreased in the PAD and diabetes groups. However, the same effect was seen in the healthy subgroup. In consideration of the present inclusion criteria, use of medical compression stockings is safe and feasible in patients with diabetes or PAD. This study did not find relevant impairment of microperfusion parameters under compression therapy in these patient subgroups in physiologic body positions. NCT03384758.
| S-EPMC7279622 | biostudies-literature
Project description:BackgroundVenous thromboembolism (VTE) remains a common problem in critically ill patients. Pharmacologic prophylaxis is currently the standard of care based on high-level evidence from randomized controlled trials. However, limited evidence exists regarding the effectiveness of intermittent pneumatic compression (IPC) devices. The Pneumatic compREssion for preventing VENous Thromboembolism (PREVENT trial) aims to determine whether the adjunct use of IPC with pharmacologic prophylaxis compared to pharmacologic prophylaxis alone in critically ill patients reduces the risk of VTE.Methods/designThe PREVENT trial is a multicenter randomized controlled trial, which will recruit 2000 critically ill patients from over 20 hospitals in three countries. The primary outcome is the incidence of proximal lower extremity deep vein thrombosis (DVT) within 28 days after randomization. Radiologists interpreting the scans are blinded to intervention allocation, whereas the patients and caregivers are unblinded. The trial has 80 % power to detect a 3 % absolute risk reduction in proximal DVT from 7 to 4 %.DiscussionThe first patient was enrolled in July 2014. As of May 2015, a total of 650 patients have been enrolled from 13 centers in Saudi Arabia, Canada and Australia. The first interim analysis is anticipated in July 2016. We expect to complete recruitment by 2018.Trial registrationClinicaltrials.gov: NCT02040103 (registered on 3 November 2013). Current controlled trials: ISRCTN44653506 (registered on 30 October 2013).
| S-EPMC4972959 | biostudies-literature
Project description:Postthrombotic syndrome (PTS) is a burdensome and costly complication of deep vein thrombosis (DVT) that develops in 20%-40% of patients within 2 years after proximal DVT. In the absence of effective curative treatment, management of PTS relies on its prevention after DVT. The effectiveness of elastic compression stockings (ECS) to prevent PTS is uncertain. We present an overview of published studies assessing the efficacy of ECS to prevent PTS and present the protocol for the CELEST clinical trial. While previous open-label randomized trials have reported a 50% risk reduction in PTS in patients treated with >30 mm Hg ankle pressure ECS, a large double-blind trial reported no effect of ECS. We discuss the main potential limitations of these trials, including a placebo effect and suboptimal compliance to ECS. We present the protocol of the CELEST double-blind randomized trial comparing 2 years of high strength (ankle pressure 35 mm Hg) versus lower strength (ankle pressure 25 mm Hg) ECS in the prevention of PTS after a first acute symptomatic, unilateral, proximal DVT. The use of lower-strength ECS than that used in previous studies should favor compliance. CELEST may provide important evidence about the efficacy of ECS in the prevention of PTS after DVT. The results will be interpreted in the light of results from recent clinical trials assessing ECS for PTS prevention that reported that the duration of ECS use should be tailored to the individual, if ECS are efficacious in the prevention of PTS.
| S-EPMC7695566 | biostudies-literature
Project description:IntroductionChronic venous insufficiency (CVI) is a common disease affecting mainly lower limbs and significantly influencing the quality of life. This study aims to estimate the prevalence of CVI in the Qassim Region and test the effectiveness of compression stockings as an intervention option.MethodsA cross sectional study was conducted to assess the prevalence of CVI among patients visiting primary health care (PHC) centers in the Qassim Region. CVI patients were diagnosed and classified using the clinical, etiologic, anatomical, and pathophysiological (CEAP) scale. They were randomly divided into two groups, one using compression stockings and the other standard medical therapy. A clinical follow up was done using multiple scale system including CEAP scale. Data analysis was performed using SPSS.ResultsAmong the 226 screened patients, 138 (61.1%) were diagnosed as having CVI (69% female and 45% male, p<0.001). Compared to the baseline, both the clinical and venous scores for CVI at the follow-up were significantly lower among patients using compression stockings, p=0.002 and p=0.003, respectively. Regression analysis suggested that, after controlling for age, sex and body mass index, compliance was the main factor responsible for a significant reduction in the clinical score among CVI patients.ConclusionsChronic venous insufficiency is very common in the Qassim Region. Compression stockings are highly effective in improving clinical symptoms and signs of CVI.Trial registrationThis study is registered at www.clinicaltrials.gov(NCT02050061).
| S-EPMC4257358 | biostudies-literature
Project description: Not available
| S-EPMC6477662 | biostudies-literature
Project description:IntroductionHospital-acquired thrombosis (HAT) is defined as any venous thromboembolism (VTE)-related event during a hospital admission or occurring up to 90 days post discharge, and is associated with significant morbidity, mortality and healthcare-associated costs. Although surgery is an established risk factor for VTE, operations with a short hospital stay (<48 hours) and that permit early ambulation are associated with a low risk of VTE. Many patients undergoing short-stay surgical procedures and who are at low risk of VTE are treated with graduated compression stockings (GCS). However, evidence for the use of GCS in VTE prevention for this cohort is poor.Methods and analysisA multicentre, cluster randomised controlled trial which aims to determine whether GCS are superior in comparison to no GCS in the prevention of VTE for surgical patients undergoing short-stay procedures assessed to be at low risk of VTE. A total of 50 sites (21 472 participants) will be randomised to either intervention (GCS) or control (no GCS). Adult participants (18-59 years) who undergo short-stay surgical procedures and are assessed as low risk of VTE will be included in the study. Participants will provide consent to be contacted for follow-up at 7-days and 90-days postsurgical procedure. The primary outcome is the rate of symptomatic VTE, that is, deep vein thrombosis or pulmonary embolism during admission or within 90 days. Secondary outcomes include healthcare costs and changes in quality of life. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, measured at an individual level, using hierarchical (multilevel) logistic regression.Ethics and disseminationEthical approval was granted by the Camden and Kings Cross Research Ethics Committee (22/LO/0390). Findings will be published in a peer-reviewed journal and presented at national and international conferences.Trial registration numberISRCTN13908683.
| S-EPMC9853211 | biostudies-literature