Evaluating whether perioperative systemic tranexamic acid together with topical hemocoagulase reduces axillary drain output and seroma formation in breast cancer patients undergoing axillary lymph node dissection.

Evaluating the impact of perioperative systemic tranexamic acid and topical hemocoagulase on reducing axillary drain output and seroma formation in breast cancer patients undergoing axillary lymph node dissection. - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095760

Enrollment

Registered

2025-10-09

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Intravenous tranexamic acid, oral tranexamic acid, topical hemocoagulase: Injection tranexamic acid (15mg/kg) IV given 30 mins before the induction of anesthesia. After completion of Ax

Eligibility

Inclusion criteria

Inclusion criteria: Cases of breast carcinoma with TNM staging- T-1 T-2 T-3 N-0 N-1 N-2 M-0 Undergoing Modified radical mastectomy and breast conservation surgery

Exclusion criteria

Exclusion criteria: 1.Cases of Breast Carcinoma with TNM staging T4N3Mo 2.Cases with bilateral Carcinoma breast 3.Cases undergoing palliative mastectomy 4.Cases of breast carcinoma in males 5.Patients with a history of radiation therapy to the axilla, lymphedema of the affected upper limb, clotting disorders, active thromboembolic disease, pregnancy, lactation, or allergic to Tranexamic acid or Hemocoagulase. 6.Patients who developed hematoma after surgery.

Design outcomes

Primary

Measure	Time frame
To compare the cumulative axillary drain output measured daily in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years	—

Secondary

Measure	Time frame
To compare the day of axillary drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years;To compare the incidence of seroma formation after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years;To compare the volume and number of seroma aspirations done in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years;To compare the incidence of Surgical site infection after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years	—

Measure

Time frame

To compare the day of axillary drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years;To compare the incidence of seroma formation after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years;To compare the volume and number of seroma aspirations done in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years;To compare the incidence of Surgical site infection after drain removal in test group (tranexamic acid + hemocoagulase) with control group (standard care) in breast cancer patients undergoing axillary lymph node dissectionTimepoint: 3 years

—

Countries

India

Contacts

Public ContactDr Vigneshwar M

Jawaharlal Institute of Postgraduate Medical Education and Research

dr.sreenathgs@gmail.com9486690883

Outcome results

None listed

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