| CTRI Number |
CTRI/2025/10/095760 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
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. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vigneshwar M |
| Designation |
Junior Resident, Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery,2 nd floor,Hospital block,Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6379147323 |
| Fax |
|
| Email |
vigneshwarmillar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreenath G S |
| Designation |
Additional Professor, Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery,2 nd floor,Hospital block,Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486690883 |
| Fax |
|
| Email |
dr.sreenathgs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vigneshwar M |
| Designation |
Junior Resident, Department of Surgery |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery,2 nd floor,Hospital block,Jawaharlal Institute of Postgraduate Medical Education and Research
Pondicherry
PONDICHERRY
605006
India |
| Phone |
6379147323 |
| Fax |
|
| Email |
vigneshwarmillar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, India- 605006 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, India- 605006 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vigneshwar M |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry
Pondicherry
PONDICHERRY |
6379147323
vigneshwarmillar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Human studies) for Intervention studies, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intravenous tranexamic acid, oral tranexamic acid and topical hemocoagulase is administered |
Injection tranexamic acid (15mg/kg) IV given 30 mins before the induction of anesthesia. After completion of Axillary lymph node dissection, 4 drops/cm2 of Topical Hemocoagulase (strength 0.2 U/mL) are sprayed over the raw surface of the axilla and oral tranexamic acid tablet 500mg is given thrice daily for the next 5 days |
| Comparator Agent |
No intervention is done |
No intervention is done. Standard care is provided |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
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
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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 dissection |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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 dissection |
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 dissection |
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 dissection |
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 dissection |
3 years |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel group, 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. The members of Test Group will be receiving injection tranexamic acid (15mg/kg) IV route 30 mins before the induction of anesthesia. After completion of ALND, 4 drops/cm2 of H (strength 0.2 U/mL) are sprayed over the raw surface of the axilla of the test group. Control group receives routine care. Test Group will also receive oral tranexamic acid tablet 500mg thrice daily for the next 5 days and the Control Group will be provided routine medications.The cases will be followed up for a period of 30 days.
The primary outcome is 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 dissection.The secondary outcomes are :
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 dissectionTo 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 dissection 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 dissection 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 dissection |