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Role of Tranexamic acid and Hemocoagulase in axillary lymph node dissection: a double blinded superiority trial

To study the efficacy of Tranexamic acid with Hemocoagulase in minimising cumulative axillary drain output in breast cancer patients undergoing axillary lymph node dissection- double blinded superiority trial. - HEXA

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041616
Enrollment
70
Registered
2022-04-04
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Tranexamic acid, Hemocoagulase: Intravenous administration of Tranexamic acid 15mg/kg 30 minutes before surgery. Intraoperative local application of Hemocoagulase solution 4drops/cm2 of

Sponsors

Harshit Verma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All breast cancer patients who will undergo axillary lymph node dissection.

Exclusion criteria

Exclusion criteria: Patient who has received prior radiation therapy to the axilla. Patients with history of known allergy to drugs used. Patients who are known case of clotting disorder or active thromboembolic disease. Patients pregnant or lactating. Patients with past or current history of lymphedema of limb on the affected side. Patients not willing to participate in the study.

Design outcomes

Primary

MeasureTime frame
To measure and compare the cumulative axillary drain output in breast cancer patients undergoing axillary lymph node dissection treated with Tranexamic acid plus Hemocoagulase versus placebo.Timepoint: 30 days

Secondary

MeasureTime frame
Days after axillary drain is removedTimepoint: Till axillary drain is in situ;Frequency and volume of axillary seroma aspirationsTimepoint: till 30 days from surgery;Incidence of surgical site infectionTimepoint: till 30 days from surgery

Countries

India

Contacts

Public ContactHarshit Verma

All India Institute of Medical Sciences, Patna

drprashantks@aiimspatna.org8809645678

Outcome results

None listed

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