Varicose veins Vascular Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients aged 18 years or over undergoing Phlebectomy for chronic venous insufficiency of the lower limbs classified as clinical class two of the Clinical Etiologic Anatomic and Pathophysiologic classification (CEAP); primary Varicose veins of the lower limbs with indication for surgical treatment by Phlebectomy; both genders; ultrasound mapping for Varicose vein surgery performed in all patients
Exclusion criteria
Exclusion criteria: Altered hematological laboratory tests; use of anticoagulant or antiplatelet drugs; acute Deep vein thrombosis or Deep vein thrombosis without recanalization on ultrasound; Varicose veins with great saphenous vein involvement; previously documented Thrombophilia; previous hematological diseases; active or in remission cancer; self reported lung disease; peripheral arterial insufficiency with ankle brachial index below 0.9
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the impact of adding Tranexamic acid to the tumescent anesthetic solution on hematoma formation on the seventh day after Ambulatory phlebectomy for Varicose veins compared with the standard tumescent solution assessed by grading standardized preoperative and seventh day postoperative photographic records by two independent blinded raters using a six point severity scale ranging from zero to five with analysis of mean and median hematoma scores between groups | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes were pre specified adverse events including Deep vein thrombosis Superficial thrombophlebitis wound infection and allergic reactions were monitored as a safety endpoint throughout the study period | — |
Countries
BR
Contacts
Angiocentro Clínica Médica, LTDA, ME