Varisolve® polidocanol microfoam compared with surgery or sclerotherapy in the management of varicose veins in the presence of trunk vein incompetence: European randomized controlled trial

2006 ◽  
Vol 21 (4) ◽  
pp. 180-190 ◽  
Author(s):  
D Wright ◽  
J P Gobin ◽  
A W Bradbury ◽  
P Coleridge-Smith ◽  
H Spoelstra ◽  
...  
Keyword(s):  
Alternative Treatment ◽  
Varicose Veins ◽  
Controlled Trial ◽  
Prospective Trial ◽  
Additional Treatment ◽  
Open Label ◽  
Vein Thrombosis ◽  
Deep Vein ◽  
To Receive ◽  
Treatment Surgery

Objective: To compare the safety and efficacy of Varisolve® 1% polidocanol microfoam sclerosant with alternative treatments for patients with varicose veins and trunk vein incompetence. Methods: An open-label, multicentre, prospective trial of 710 patients randomized to receive either Varisolve® or alternative treatment (surgery or sclerotherapy). The endpoint was ultrasound-determined occlusion of trunk vein(s) and elimination of reflux, analysed against a non-inferiority hypothesis. Results: Overall, non-inferiority was demonstrated with 83.4% efficacy for Varisolve® compared with 88.1% for alternative treatment at three months, and the corresponding magnitudes were 78.9 and 80.4% at 12 months. Surgery was superior to Varisolve®, but the success rate of 68.2% for Varisolve® (surgery 87.2%) was poor compared with 93.8% success for Varisolve® achieved in those randomized to Varisolve® or sclerotherapy. Varisolve® was superior to sclerotherapy at 12 months ( P = 0.001). Deep vein thrombosis occurred in 11/437 (2.5%) after Varisolve®, in 1/125 (0.8%) after sclerotherapy and in none after surgery. No pulmonary emboli were detected. Conclusion: Overall, Varisolve® was non-inferior to alternative treatment. Surgery was more efficacious, but Varisolve® caused less pain and patients returned to normal more quickly. The Varisolve® technique is a useful additional treatment for varicose veins and trunk vein incompetence.

Appropriate Use of Vena Cava Filters

2009 ◽  
Vol 02 ◽  
pp. 28
Author(s):  
David Green ◽  
Keyword(s):  
Controlled Trial ◽  
Vena Cava ◽  
Major Hemorrhage ◽  
Filter Placement ◽  
Vein Thrombosis ◽  
Vena Cava Filters ◽  
Life Saving ◽  
Risk Patients ◽  
Deep Vein ◽  
To Receive

Vena cava filters are potentially life-saving devices that are used to prevent embolization of thrombi that develop in the veins of the lower extremities and pelvis. Temporary filters are indicated for at-risk patients with contraindications to anticoagulation and to prevent pulmonary emboli from occurring during thrombolytic therapy for lower-extremity or pelvic deep vein thrombosis (DVT). Permanent filters are placed in those patients with a continuing risk for embolization not able to receive, or who have failed, anticoagulant therapy. While a randomized, controlled trial showed that filters decreased the frequency of new emboli in cancer patients with DVT, their use was associated with an increase in new DVT, and there was no survival benefit. Successful filter placement requires expertise, is not always effective, and is expensive. In conclusion, filters are indicated in acute conditions when the risk for major hemorrhage obviates the use of full-dose anticoagulation. However, filters should be removed and anticoagulation initiated as soon as the risk for serious bleeding has subsided.

Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study

2018 ◽  
Vol 118 (09) ◽  
pp. 1668-1678 ◽  
Author(s):  
Giancarlo Agnelli ◽  
Cecilia Becattini ◽  
Rupert Bauersachs ◽  
Benjamin Brenner ◽  
Mauro Campanini ◽  
...  
Keyword(s):  
Venous Thromboembolism ◽  
Primary Outcome ◽  
National Guidelines ◽  
Open Label ◽  
Safety Outcome ◽  
Vein Thrombosis ◽  
Patients With Cancer ◽  
Acute Venous Thromboembolism ◽  
Deep Vein ◽  
To Receive

AbstractInternational and national guidelines recommend low-molecular-weight heparin for the treatment of venous thromboembolism (VTE) in patients with cancer. The aim of the Caravaggio study is to assess whether oral apixaban is non-inferior to subcutaneous dalteparin for the treatment of acute proximal deep vein thrombosis and/or pulmonary embolism in patients with cancer. The study is an investigator-initiated, multi-national, prospective, randomized, open-label with blind end-point evaluation (PROBE), non-inferiority clinical trial (NCT03045406). Consecutive patients are randomized to receive oral apixaban or subcutaneous dalteparin for 6 months. Apixaban is given at a dose of 10 mg twice daily for the first 7 days and then 5 mg twice daily; dalteparin is given at a dose of 200 IU/kg for the first month and then 150 IU/kg once daily. The primary outcome of the study is objectively confirmed recurrent VTE as assessed by a central independent adjudication committee unaware of study treatment allocation. The primary safety outcome is major bleeding defined according to the guidelines of the International Society of Thrombosis and Haemostasis. Assuming a 6-month incidence of the primary outcome of 7% with dalteparin and an upper limit of the two-sided 95% confidence interval of the hazard ratio below the pre-specified margin of 2.00, 1,168 patients will be randomized considering an up to 20% loss in total patient-years (β = 80%; α one-sided = 0.025). The Caravaggio study has the potential, along with other recently performed or on-going studies, to make less cumbersome the management of VTE in patients with cancer by replacing parenteral with oral anticoagulation.

A Double-Blind Trial of Intramuscular Stanozolol in the Prevention of Postoperative Deep Vein Thrombosis Following Elective Abdominal Surgery

1984 ◽  
Vol 51 (01) ◽  
pp. 071-074 ◽  
Author(s):  
S L Blarney ◽  
B M McArdle ◽  
P Burns ◽  
D C Carter ◽  
G D O Lowe ◽  
...  
Keyword(s):  
Deep Vein Thrombosis ◽  
Placebo Group ◽  
Controlled Trial ◽  
Double Blind Trial ◽  
Double Blind ◽  
Vein Thrombosis ◽  
Postoperative Deep Vein Thrombosis ◽  
Deep Vein ◽  
To Receive

SummaryFibrinolytic shutdown may be important in the development of postoperative deep vein thrombosis (DVT). We have previously shown that stanozolol 50 mg, given intramuscularly 24 hr before surgery, prevents the decrease in plasminogen activator activity (PA) seen on the first postoperative day in patients at high risk of DVT. To investigate the role of fibrinolytic shutdown in causation of DVT, sixty patients were randomised in a double-blind controlled trial to receive stanozolol or placebo intramuscularly, and DVT was detected by leg scanning and confirmed by venography. Scan positive DVT occurred in IT of 31 placebo patients (35%) and 12 of 29 who received stanozolol (41%). A significant decrease in PA was confirmed in the placebo group, while stanozolol caused a significant increase in PA on the first postoperative day. Patients in either group who did not develop DVT showed minimal changes in PA. We conclude that prevention of fibrinolytic shutdown by this regimen of stanozolol does not prevent postoperative DVT, and that further studies are required to clarify the relationships of postoperative fibrinolysis and DVT.

Controlled Trial of the Sequential Use of Streptokinase and Ancrod in the Treatment of Deep Vein Thrombosis of Lower Limb

1977 ◽  
Vol 37 (02) ◽  
pp. 222-232 ◽  
Author(s):  
D. A Tibbutt ◽  
C. N Chesterman ◽  
E. W Williams ◽  
T Faulkner ◽  
A. A Sharp
Keyword(s):  
Deep Vein Thrombosis ◽  
Clinical Improvement ◽  
Anticoagulant Therapy ◽  
Lower Limb ◽  
Oral Anticoagulant ◽  
Controlled Trial ◽  
Oral Anticoagulant Therapy ◽  
Control Group ◽  
Vein Thrombosis ◽  
Deep Vein

SummaryTreatment with streptokinase (‘Kabikinase’) was given to 26 patients with venographically confirmed deep vein thrombosis extending into the popliteal vein or above. Treatment was continued for 4 days and the patients were allocated randomly to oral anticoagulant therapy or a course of treatment with ancrod (‘Arvin’) for 6 days followed by oral anticoagulant therapy. The degree of thrombolysis as judged by further venographic examination at 10 days was not significantly different between the 2 groups. The majority of patients showed clinical improvement but there was no appreciable difference between the groups at 3 and 6 months. Haemorrhagic complications were a more serious problem during the period of treatment with ancrod than during the equivalent period in the control group.

Trial of Aspirin and RA 233 in Prevention of Post-operative Deep Vein Thrombosis

1973 ◽  
Vol 30 (01) ◽  
pp. 018-024 ◽  
Author(s):  
Edward H. Wood ◽  
Colin R.M. Prentice ◽  
D. Angus McGrouther ◽  
John Sinclair ◽  
George P. McNicol
Keyword(s):  
Deep Vein Thrombosis ◽  
Controlled Trial ◽  
Oral Anticoagulants ◽  
Antithrombotic Agent ◽  
Fractured Neck Of Femur ◽  
Neck Of Femur ◽  
Vein Thrombosis ◽  
Effective Prophylaxis ◽  
Deep Vein ◽  
Calf Vein

SummaryAlthough the oral anticoagulants provide effective prophylaxis against postoperative deep vein thrombosis following fracture of neck of femur there is a need for an antithrombotic agent which needs less laboratory control and does not cause haemorrhagic complications. It has been suggested that drugs causing inhibition of platelet function may fulfil these requirements. A controlled trial was carried out in which aspirin, RA 233, or a combination of these drugs was compared with a placebo in the prevention of post-operative deep vein thrombosis. In thirty patients undergoing surgery for fractured neck of femur the incidence of post-operative calf vein thrombosis, as detected by 125I-fibrinogen scanning, was not significantly different between the untreated and treated groups.

Impact of Temperature on Injection-Related Pain Caused by Subcutaneous Administration of Ustekinumab: A Three-arm Crossover Open-label Randomized Controlled Trial

2017 ◽  
Vol 1 (3) ◽  
pp. 117-127
Author(s):  
Yasaman Mansouri ◽  
Yasmin Amir ◽  
Michelle Min ◽  
Raveena Khanna ◽  
Ruiqi Huang ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Subcutaneous Administration ◽  
Open Label ◽  
Post Dose ◽  
Subcutaneous Injections ◽  
Pain Scores ◽  
Observational Cohort ◽  
Vas Scores ◽  
Pre Treatment ◽  
To Receive

Background: Adherence to subcutaneous biologic agents for the treatment of psoriasis can be negatively influenced by injection pain.Objective: To explore the differences in injection site pain when patients are pre-treated with heat or cold, versus no pre-treatment prior to administration of a subcutaneous biologic agent.Methods: In an observational cohort study, patients receiving subcutaneous injections of ustekinumab were randomly assigned to receive pretreatment with ice, heat, or no intervention over three visits. Post-dose, patients rated pain on a 100 mm visual analogue scale (VAS).Results: There was an increase in the VAS score for both heat (2.51, P=0.30) and ice (3.33, P=0.16), compared to no intervention. No differences were found between the two intervention groups (-0.83, P=0.73). On average, females had the same VAS scores with ice compared to that of no intervention (-0.12, P=0.97) and a non–significant decrease of 3.29 points (P=0.38) with heat. Males had increased pain scores by 5.65 points (P=0.07) with ice and by 6.39 points (P=0.04) with heat.Limitations: Pain is a subjective measurement and objective quantification is difficult.Conclusions: On average, neither heat nor cold application reliably reduced pain. Our results do not support the application of heat or cold prior to ustekinumab injection.

Sign in / Sign up

Export Citation Format

Share Document