Role of Tranexamic Acid in Decreasing Drain Output after Breast Cancer Surgery

Phase 3

• Conditions: Health Condition 1: C50- Malignant neoplasm of breast

• Registration Number: CTRI/2021/09/036108
• Lead Sponsor: AIIMS Bhubaneswar

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients with biopsy-proven breast malignancy in the age group of 18-70 years.

2.Patients undergoing axillary lymph node dissection along with mastectomy.

3.Patients undergoing axillary lymph node dissection along with BCS with or without major

reconstruction

4.Patients undergoing curative surgeries.

Exclusion Criteria

1.Patients undergoing SLNB alone.

2.Patients undergoing simultaneous surgery in other organs along with breast cancer surgery.

3.Advanced breast malignancy with bleeding breast lesions.

4.Pregnant and breastfeeding women.

5.Patients with coronary artery disease.

5.Patients with a history of deep venous thrombosis (DVT).

6.Patients with a history of malignancy other than breast.

7.Patients undergoing resection with residual disease in-situ (R2 resection).

8.Patients who are not giving consent to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To determine the Role of Perioperative Tranexamic Acid in Reducing Drain Volume <br/ ><br>among Breast Cancer Patients Undergoing Axillary Lymph Node Dissection.Timepoint: Baseline, 10 days, 20 days, 30 days, Cumulative drain volume till drain removal.

Secondary Outcome Measures

Name	Time	Method
1. Duration of the axillary drain. <br/ ><br>2. Incidence of Seroma formation within 90 days of surgery. <br/ ><br>3. Incidence of Surgical Site Infection (SSI) within 90 days of surgery. <br/ ><br>4. Usage of Antibiotics. <br/ ><br>5. Number of visits to wound clinic within 90 days of surgery. <br/ ><br>6. Delay in adjuvant therapy. <br/ ><br>7. Incidence of side effects of Tranexamic acid.Timepoint: Baseline, 10 days, 20 days, 30 days and 90 days.