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Comparison of liquid anesthetics with and without Tranexamic acid a medication that helps reduce bleeding in surgery to remove Varicose veins of the legs

Randomized triple blind study comparing anesthetic solution with and without Tranexamic acid for microsurgical treatment of Varicose veins

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-8pzbk3c
Enrollment
66
Registered
2026-07-09
Start date
2021-07-26
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Varicose veins Vascular Diseases

Interventions

This is a triple-blind randomized controlled trial with one to one allocation in two parallel groups a total of 66 patients with primary Varicose veins of the lower limbs clinical class two of the Cli

Sponsors

Angiocentro Clínica Médica, LTDA, ME
Lead Sponsor
Irmandade da Santa Casa de Londrina
Collaborator

Eligibility

Age
18 Years to No maximum

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

MeasureTime 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

MeasureTime 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

Public ContactFelipe Neto

Angiocentro Clínica Médica, LTDA, ME

contato@drfelipecoelho.com.br+55(43)991804546

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Aug 10, 2026