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News about clinical research: trials, studies, case reports, etc.

Low dose aspirin and compression does not increase healing of VLU

Low dose aspirin does not increase healing of venous leg ulcers (VLU) when used in addition to effective compression, according to researchers from the University of Auckland, New Zealand. The study, funded by the New Zealand Health Research Council and conducted by researchers at the University's National Institute for Health Innovation, found 150mg aspirin a day in addition to compression bandaging did not increase venous ulcer healing.

Treating thrombo-vascular complications in kidney disease

Researchers at Boston University School of Medicine (BUSM) have discovered a potential treatment target to prevent chronic kidney disease patients from developing thrombosis without causing bleeding complications - an unwanted and perplexing side effect. They say the strategy offers a much-needed therapeutic alternative to standard-of-care heparin, which throws off the finely-tuned balance between pro-clotting and anticoagulant factors in blood vessels that work to keep fluid flowing while protecting against excessive bleeding after injuries.

May-Thurner Syndrome is more common in women

May-Thurner Syndrome (MTS) - sometimes inaccurately used in the literature to describe iliac vein compression - is more common in women with a ratio of at least 2:1 compared with men, according to a systematic review, according to researchers from the University of Pittsburgh and Yale University. The authors noted that women with MTS tend to present at a younger age and have increased risk of pulmonary embolism compared with men although the latter experience more pain with the syndrome.

ERVA: Endovenous ablation betters compression therapy

Early endovenous ablation of superficial venous reflux as an adjunct to compression therapy is associated with a shorter time to healing of venous leg ulcers than compression therapy alone, according to the firsts results from the Early Venous Reflux Ablation (EVRA) ulcer randomised controlled trial.

RSM’s Venous Forum issues leg ulcer guidance

The Royal Society of Medicine’s Venous Forum (UK) has issued a guidance document for the ‘Management of patients with Leg Ulcers, to ensure that all patients with leg ulceration are offered the most appropriate care. In the guidance document, the Venous Forum state that leg ulcers continue to cause great distress to patients, cost the NHS millions of pounds each year and the prevalence of leg ulcers is increasing.

andexanet stops dangerous bleeding factor Xa inhibitors patients

The experimental drug andexanet was associated with control of serious bleeding in patients taking a common class of anticoagulants known as Factor Xa inhibitors, according to interim clinical trial results presented at the American College of Cardiology's 67th Annual Scientific Session. Millions of patients take Factor Xa inhibitors, which elevate the risk of serious bleeding.

Know the danger signs of CVI and VTE in pregnant patients

A review of the literature on chronic venous insufficiency (CVI) in pregnant women reveals considerable guidance for their treatment. CVI occurs in up to 80% of pregnant women, while around 7 of every 1,000 pregnant mothers face venous thromboembolism (VTE) and pulmonary embolism (PE). Pregnancy causes significant hemodynamic changes within the circulatory system.

Varicose veins associated with DVT incidence

Adults who were diagnosed with varicose veins have a significantly increased risk of incident deep venous thrombosis (DVT), although whether the association between varicose veins and DVT is causal or represents a common set of risk factors requires further research.

Safety and efficacy of shorter, lower dose EKOS therapy for PE

One-year results from the OPTALYSE PE trial confirm that bilateral pulmonary embolism (PE) patients treated in as little as two hours with a total tissue plasminogen activator (tPA) dose as low as 8mg continue to show improvements in RV/LV ratio over the long term with a very low all-cause mortality rate of 2%.

Extent of venous injury during CIED lead extraction

The first large study to characterise the histopathology of extracted leads from cardiac implantable electronic devices (CIEDs) shows that microscopic venous injuries during transvenous lead extraction (TLE) are common but may not be recognised clinically.

Enrolment in KNOCOUT PE Study to protocols for EKOS Therapy

BTG has announced the commencement of the KNOCOUT PE study, which will measure how hospitals and patients are benefitting from a new standard of care in the treatment of pulmonary embolism (PE) utilising EKOS therapy with faster, and even safer protocols, proven effective in the OPTALYSE PE study. The OPTALYSE PE study found PE can be treated effectively with EKOS therapy over a much shorter period and at safer thrombolytic doses far below the previous standard.

EVTA and the risk factors for thrombotic complications

There was no statistical difference in successful closure rates when comparing radiofrequency (RFA) and endovenous laser (EVLA) ablation techniques, according to a large single centre experience with endovenous thermal ablation (EVTA) examining the risk factors for thrombotic complications. However, the type of procedure (EVLA), larger vein diameters and treatment of the Great saphenous veins (GSV) were associated with a greater thrombotic complication rate, but type of vein was the most significant independent predictor.

ATTRACT - clot-busting drugs do not benefit most patients with DVT

The results of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) study have revealed that clot busting drugs and medical devices do not improve outcomes for patients experiencing deep vein thrombosis (DVT), nor do they prevent the development of post-thrombotic syndrome (PTS) when compared with conventional blood thinning medications.

CMU to develop sterilising device reducing VAP infections

Cardiff Metropolitan University (CMU) has secured funding to support an interdisciplinary collaboration arising from the Welsh Crucible programme that looks at the design and development of an innovative sterilising device for venous access ports (VAPs). The project team's aim is to develop a sterilising device to reduce infections in VAPs for patients who require long term and repeated intravenous treatment. 

Pelvic veins scan paper wins 1st prize at the ACP annual meeting

Judy Holdstock of The Whiteley Clinic won the first prize at the American College of Phlebology (ACP) annual meeting in Austin, TX, for her paper that showed how a pelvic veins scan, performed with duplex ultrasound and the Holdstock protocol shows more than other current tests. Duplex ultrasound scanning is done lying flat, or just across the abdomen, or MRI, CT or venograms, have all overestimated a pelvic vein problem called “Nutcracker” phenomena.

Varithena receives finalised category I CPT codes

BTG plc has announced that the US Centers for Medicare and Medicaid Services have published the final fee schedule for new Category I CPT codes for Varithena procedures. The codes will be effective from 1 January 2018.

Prognosis of infected diabetic foot ulcer is worse than thought

The prognosis for people with an infected diabetic foot ulcer is worse than was previously thought, according to a study by researchers from the University of Leeds. More than half the patients in the research study did not see their ulcer heal over a year - and one in seven had to have part or all of their foot amputated.

Continuous aspiration mechanical thrombectomy feasible for PE

Continuous aspiration mechanical thrombectomy, with the Indigo Mechanical Thrombectomy System (Penumbra), is a feasible and promising intervention for patients with sub-massive pulmonary embolism (PE) and a contraindication to thrombolysis, according a small cases series by researchers from Miami Cardiac & Vascular Institute, Baptist Hospital of Miami, Miami, FL.

The discord outcome analysis in randomised clinical trials

The recipe for most randomised clinical trials (RCTs) on varicose vein treatment includes a quality of life assessment, a clinical severity assessment and an ultrasound examination to confirm that the target vein is occluded. This may be achieved using the Aberdeen varicose vein questionnaire (AVVQ), the venous clinical severity score (VCSS) and saphenous occlusion rates on duplex ultrasound. Subsequently change scores are used to compare differences before and after treatment. Usually an improvement is recognised with a positive change score during follow-up.

Iliocaval and infrainguinal PTVO and iliac vein stents

Endovascular treatment of iliocaval and infrainguinal post-thrombotic venous obstruction results do not appear to be adversely affected by extension of the iliac vein stents into the femoral venous system, according to a study in the Journal of Vascular Surgery: Venous and Lymphatic Diseases.


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