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

Phase 1

• Conditions: Post-operative hematoma; MedDRA version: 20.1Level: LLTClassification code 10064765Term: Breast hematomaSystem Organ Class: 100000004872; MedDRA version: 20.0Level: LLTClassification code 10018857Term: Haematoma postoperativeSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2018-000910-39-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA UDINE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 84

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified