Efficacy of tranexamic acid directly distributed over the surgical area in reducing the blood loss related to mastectomy and breast reconstruction with implant

Efficacy of tranexamic acid in reducing post-operative bleeding in oncologic-reconstructive breast surgery - Topical use of tranexamic acid in reconstructive breast surgery

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-000910-39-IT

Enrollment

Registered

2021-09-09

Start date

2018-12-13

Completion date

Unknown

Last updated

2021-10-08

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

Conditions

Post-operative hematoma MedDRA version: 20.1 Level: LLT Classification code 10064765 Term: Breast hematoma System Organ Class: 100000004872 MedDRA version: 20.0 Level: LLT Classification code 10018857 Term: Haematoma postoperative System Organ Class: 100000004863

Interventions

Trade Name: UGUROL - 500 MG/ 5 ML SOLUZIONE INIETTABILE, PER USO ORALE E LOCALE 6 FIALE Pharmaceutical Form: Solution for infusion Route of administration of the placebo: Inhalation use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult women, capable of understanding and will, affected by breast cancer and candidate to mastectomy and immediate breast reconstruction with implants. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 29

Exclusion criteria

Exclusion criteria: Anamnesis of thromboembolism, known pro-coagulative alterations, ASA (American Society of Anesthesiology) Score IV

Design outcomes

Primary

Measure	Time frame
Main Objective: To verify if the topical application of tranexamic acid reduces post-operative bleedings quantified as drains output. ;Secondary Objective: Data concerning the complications occured until the end of follow-ip will be collected and analyzed. ;Primary end point(s): will be considered significant a 30% reduction in the drains output in the first 36 post-operative for the group of women receiving tranexamic acid compared to those recivieng physiologic solution. ;Timepoint(s) of evaluation of this end point: first post-operative 36 hours	—

Measure

Time frame

Main Objective: To verify if the topical application of tranexamic acid reduces post-operative bleedings quantified as drains output. ;Secondary Objective: Data concerning the complications occured until the end of follow-ip will be collected and analyzed. ;Primary end point(s): will be considered significant a 30% reduction in the drains output in the first 36 post-operative for the group of women receiving tranexamic acid compared to those recivieng physiologic solution. ;Timepoint(s) of evaluation of this end point: first post-operative 36 hours

—

Secondary

Measure	Time frame
Secondary end point(s): To verify if the reduction of post-operative bleedings translates into a reduction of medium/long-term reconstructive complications such as infection, late seroma capsular contracture. ;Timepoint(s) of evaluation of this end point: Until the end of follow-up (12 months)	—

Countries

Italy

Contacts

Public ContactSegreteria Clinica di Chirurgia Pla

SOC Clinica di Chirurgia Plastica

clinicachirurgiaplastica@asuiud.sanita.fvg.it0432559432

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026