Deep Vein Thrombosis Clinical Trial
Official title:
Non-elastic Compression Garment Therapy Versus Control for Deep Vein Thrombosis: A Bayesian Adaptive Randomized Trial
NCT number | NCT03368313 |
Other study ID # | Circaid |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | November 30, 2025 |
The objective of the study is to conduct a Bayesian randomized trial comparing non-elastic compression garments applied with high pressure (Circaid group) with no compression (control group) in reducing signs and symptoms in the acute stage of DVT and subsequent postthrombotic syndrome. With a hypothesis that the Circaid group will present a quicker and more marked reduction of pain and leg swelling in the acute stage of DVT, as well as a 20% decrease in the frequency of postthrombotic syndrome within six months from the time of diagnosis of the acute deep vein thrombosis episode.
Status | Recruiting |
Enrollment | 120 |
Est. completion date | November 30, 2025 |
Est. primary completion date | November 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Age 18-80 years - Outpatients with acute deep venous thrombosis of lower extremity - Symptomatic patients - Involving femoro-popliteal and / or ilofemoral segment - Symptoms less than two weeks - Provoked or unprovoked TVP Exclusion Criteria: - History of TVP - Any allergy to the use of compression material - Severe arterial occlusive disease - Patients in whom thrombus removal is planned - Ankle index <0.5 - Inability to walk - A life expectancy of less than six months - Geographic inaccessibility that prevents adequate follow-up with or without assistance - Thrombolytic therapy outside of this study for the initial treatment of acute DVT. |
Country | Name | City | State |
---|---|---|---|
Brazil | Instituto de Ensino e Treinamento em Saúde Vascular da Bahia | Bahia | BA |
Brazil | Instituto de Cirurgia Vascular e Angiologia de Cascavel/PR | Cascavel | PR |
Brazil | Clínica Médica Longevittá | Cuiabá | Mount |
Brazil | Hospital Erasto Gaertner | Curitiba | PR |
Brazil | Hospital Santa Casa de Curitiba | Curitiba | PR |
Brazil | NICEP - Núcleo Integrado de Cirurgia Vascular e Pesquisa | Curitiba | PR |
Brazil | Sociedade Evangélica Beneficente de Curitiba | Curitiba | PR |
Brazil | Angiodiagnóstico - Instituto de Doenças Venosas e Linfáticas de Goiânia/Go | Goiânia | GO |
Brazil | Flebocurso | Londrina | PR |
Brazil | Angio Vascular Hospital LTDA | Natal | RN |
Brazil | Centro: Serviço de Cirurgia Vascular HSLPUCRS | Porto Alegre | RS |
Brazil | Clínica vascular MDC Sociedade Simples ME | Porto Alegre | RS |
Brazil | Hospital dos Servidores do Estado do Pernambuco | Recife | PE |
Brazil | Clínica Dr. Alexandre Reis EIRELI | Santos | SP |
Brazil | CIP - Fundação Faculdade de Medicina de São José do Rio Preto | São José Do Rio Preto | SP |
Brazil | SAMAR Serviços Médicos | São Paulo | SP |
Brazil | Pró Saúde Clínica Médica | Tubarão | SC |
Brazil | Pró Circulação® - Clinic of Angiology and Vascular Surgery | Xanxerê | SC |
Lead Sponsor | Collaborator |
---|---|
Pró Circulação® |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in pain level using visual analog scale | Pain level will be registered using a pain visual analog scale (VAS). The pain VAS ranges from 0 (no pain at all) to 10 (very severe pain) and is a self-reported scale where the patient is asked to mark his/her pain level on the line between the two endpoints. A higher score indicates a greater pain intensity. | Baseline visit, after 15 days, one month, six months and 12 months of followup visits. | |
Primary | Change in edema using perimetry (cm) | The circumference will be measured at two different levels of the foot and at five distinct levels of the leg, using a normal tape measure. No pressure will be applied to these measures to avoid affecting their accuracy. The measurement of the first foot is made five centimeters proximal to the base of the first proximal phalanx of the second toe and the second measurement five centimeters proximal to the first measurement. The measurement of the first leg will be performed five centimeters above the lower edge of the lateral malleolus and then every five centimeters, reaching a total of six to eight measurements, depending on the height of the leg. | Baseline visit, after 15 days, one month, six months and 12 months of followup visits. | |
Secondary | Postthrombotic syndrome (PTS) using Ginsberg's criteria | PTS will be diagnosed following Ginsberg's criteria of ipsilateral pain and swelling of legs at least one month's duration presenting the following characteristics: Worse at the end of the day or with prolonged sitting or standing, and better after a night's rest and with leg elevation. | Baseline visit, after 15 days, one month, six months and 12 months of followup visits. | |
Secondary | Postthrombotic syndrome (PTS) using Villalta's scale | The cumulative incidence and severity of post-thrombotic syndrome (PTS) will be recorded with Villalta's scale. The scale consists of five patient-rated venous symptoms (pain, cramps, heaviness, paresthesia, and pruritis) and six clinician-rated physical signs (pretibial edema, skin induration, hyperpigmentation, pain during calf compression, venous ectasia, and redness) which are each rated on a four-point scale (0=absent, 1=mild, 2=moderate, 3=severe). Points are summed to produce the total score ranging from 0-33. Patients are classified as having PTS if the score is >=5 or if a venous ulcer is present. A score of 5-9 signifies mild disease, 10-14 moderate disease, and =15 severe disease. | Baseline visit, after 15 days, one month, six months and 12 months of followup visits. | |
Secondary | Quality of life using VEINES-QOL/Sym questionnaire | VEnous INsufficiency Epidemiological and Economic Study- Quality of Life/ Symptoms (VEINES-QOL/Sym) is a 26-item patient-reported questionnaire measuring the impact of deep venous thrombosis on symptoms and quality of life. Out of two summary scores, the VEINES-QOL summary score (25 items) provides an estimate of the overall impact of deep venous thrombosis on the patient's quality of life and the VEINES-Sym summary score (10 items) measures symptom severity. This includes nine venous symptoms (heavy legs, aching legs, swelling, night cramps, heat or burning sensation, restless legs, throbbing, itching, tingling sensation), rated on a five-point Likert scale of frequency (every day, several times a week, about once a week, less than once a week, never), and leg pain rated on a six-point scale of intensity (very severe, severe, moderate, mild, very mild, none). For both scales, high scores indicate better outcomes. | Baseline visit and at one, six and 12 months of followup visits. | |
Secondary | Quality of life using PROMIS Global-10 | PROMIS-10 assesses general domains of health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. | Baseline visit and at one, six and 12 months of followup visits. | |
Secondary | Physical activity using Global Physical Activity Questionnaire | Global Physical Activity Questionnaire (GPAQ) developed by WHO collects information on physical activity participation in three settings (or domains) as well as sedentary behavior, comprising 16 questions (P1-P16). The domains are: Activity at work; Travel to and from places; Recreational activities. Metabolic Equivalents (MET) are commonly used to express the intensity of physical activities, and are also used for the analysis of GPAQ data. MET is the ratio of a person's working metabolic rate relative to the resting metabolic rate. One MET is defined as the energy cost of sitting quietly, and is equivalent to a caloric consumption of 1 kcal/kg/hour. When calculating a person's overall energy expenditure using GPAQ data, 4 METs get assigned to the time spent in moderate activities, and 8 METs to the time spent in vigorous activities. | Baseline visit and at one, six and 12 months of followup visits. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05003843 -
BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis
|
N/A | |
Recruiting |
NCT03937947 -
Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
|
||
Withdrawn |
NCT04136561 -
Novel Strategy to Encourage Early Removal of Central Venous Catheters
|
N/A | |
Completed |
NCT03420625 -
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
|
N/A | |
Recruiting |
NCT02507180 -
Safely Ruling Out Deep Vein Thrombosis in Pregnancy With the LEFt Clinical Decision Rule and D-Dimer
|
||
Completed |
NCT02555111 -
Xarelto Versus no Treatment for the Prevention of Recurrent Thrombosis in Patients With Chronic Portal Vein Thrombosis.
|
Phase 3 | |
Terminated |
NCT02469376 -
Evaluation of a New Imagingtechnologie for Thrombosis
|
Phase 1 | |
Completed |
NCT01975090 -
The SENTRY Clinical Study
|
N/A | |
Completed |
NCT02037607 -
Incidence of Venous Thromboembolism in Children Undergoing Elective Neurosurgical Procedures
|
N/A | |
Not yet recruiting |
NCT01357941 -
Need for Antepartum Thromboprophylaxis in Pregnant Women With One Prior Episode of Venous Thromboembolism (VTE)
|
N/A | |
Completed |
NCT00773448 -
Screening for Occult Malignancy in Patients With Idiopathic Venous Thromboembolism
|
N/A | |
Completed |
NCT00720915 -
D-dimer to Select Patients With First Unprovoked Venous Thromboembolism Who Can Have Anticoagulants Stopped at 3 Months
|
N/A | |
Completed |
NCT00771303 -
Ruling Out Pulmonary Embolism During Pregnancy:a Multicenter Outcome Study
|
||
Completed |
NCT00244725 -
Odiparcil For The Prevention Of Venous Thromboembolism
|
Phase 2 | |
Completed |
NCT00264277 -
D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism
|
Phase 4 | |
Completed |
NCT00365950 -
3 Months' Versus 6 Months' Anticoagulation in Patients With DVT and/or PE
|
Phase 4 | |
Completed |
NCT00182403 -
Fixed Dose Heparin Study
|
Phase 3 | |
Completed |
NCT03682419 -
Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device (OPTIMAL)
|
N/A | |
Not yet recruiting |
NCT04981327 -
The API-CALF Study: Apixaban to Treat Calf Vein Thrombosis
|
Phase 3 | |
Recruiting |
NCT03240120 -
A Study of Dabigatran Etexilate as Primary Treatment of Malignancy Associated Venous Thromboembolism
|
Phase 3 |