| CTRI Number |
CTRI/2024/12/078600 [Registered on: 26/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of Topical Tranexamic Acid in Decreasing During Operation And After Operation Bleeding After Nasal Surgery
|
|
Scientific Title of Study
|
Effectiveness of Topical Tranexamic Acid in Reducing Intraoperative and Postoperative Bleeding Following Nasal Endoscopic Sinus Surgery: Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhairavi Sharma |
| Designation |
Post graduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
OPD number 9
DEPARTMENT OF OTORHINOLARYNGOLOGY
AARUPADAI VEEDU MEDICAL COLLEGE
KIRUMAMPAKKAM
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9819814438 |
| Fax |
|
| Email |
bhairavisharma98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T.C.VIKRAM |
| Designation |
Associate Professor |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Opd number 9
Department of Otorhinolaryngology
Aarupadai Veedu Medical College and Hospital
Kirumampakkam
Pondicherry
PONDICHERRY
607402
India |
| Phone |
|
| Fax |
|
| Email |
drtcvikram@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhairavi Sharma |
| Designation |
Post graduate |
| Affiliation |
Aarupadai Veedu Medical College and Hospital |
| Address |
OPD number 9
DEPARTMENT OF OTORHINOLARYNGOLOGY
AARUPADAI VEEDU MEDICAL COLLEGE
KIRUMAMPAKKAM
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9819814438 |
| Fax |
|
| Email |
bhairavisharma98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical college and hospital
PONDY CUDDALORE MAIN ROAD , KIRUMAMPAKKAM
PONDICHERRY 607402
|
|
|
Primary Sponsor
|
| Name |
Dr.Bhairavi Sharma |
| Address |
b501 dheeraj gaurav ht2 2
off link road near infinity mall
andheri west mumbai |
| Type of Sponsor |
Other [SELF ] |
|
|
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 Bhairavi Sharma |
Aarupadai Veedu Medical College and Hospital |
Opd number 9
DEPARTMENT OF OTORHINOLARYNGOLOGY
Pondy Cuddalore Main road Kirumampakkam Bahour, Kirumampakkam, Puducherry 607402
Pondicherry
PONDICHERRY |
9819814438
bhairavisharma98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline |
It is going to be used in pre operative and post operative nasal packing i.e topically post endoscopic sinus surgeries |
| Intervention |
Tranexamic Acid |
It is going to be used in pre operative and post operative nasal packing i.e topically post endoscopic sinus surgeries as compared to saline in the control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adults of 18 years and above requiring endoscopic sinus surgery.
. Patients aged 18 and above attending ENT OPD in AVMC with conditions such as chronic rhinosinusitis with or without polyp , Antrochoanal polyp, nasal diseases requiring unilateral or bilateral endoscopic sinus surgery scheduled for nasal endoscopic sinus surgery. |
|
| ExclusionCriteria |
| Details |
Known allergy to tranexamic acid.
2. History of thromboembolic events, Coagulopathy, or use of anticoagulant medications.
3. Significant medical comorbidities (e.g., cardiovascular diseases, renal
Impairment, with uncontrolled Diabetes and Hypertension).
4. Patients being operated for nasal tumour
5. Revision endoscopic nasal surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the effectiveness of topical tranexamic acid in reducing intraoperative bleeding and immediate post op bleeding in patients undergoing endoscopic sinus surgery.
2. To assess the intra operative surgical field using Boezarts scale in both TXA group and control group in Endoscopic Sinus Surgery.
|
Intra operative checked at
5 mins
15 mins
25 mins
35 mins
post operatively checked at
Immediate post operatively
6hrs post operatively
12 hrs post operatively
24 hrs post operatively
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To detect the duration of surgery in both the groups |
1. To detect the duration of surgery in both the groups ( noting time from start of surgery to the end ) |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/12/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - data will be emailed to those interested from the following email id bhairavisharma98@gmail.com
- For how long will this data be available start date provided 24-06-2025 and end date provided 24-12-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This research outlines the design and methodology of a randomized controlled trial aimed at assessing the impact of topical tranexamic acid application preoperatively on bleeding outcomes during surgery, surgical field visibility, operative time, and postoperative complications in patients undergoing nasal endoscopic sinus surgery. Secondarily, it also seeks to resolve discrepancies between various studies related to the use of topical tranexamic acid intraoperatively and postoperatively. Patients fulfilling the inclusion criteria will be recruited and divided into two distinct groups: a control group and a test group. The test group will be given topical tranexamic acid in their nasal packs preoperatively and postoperatively, after which intraoperative and postoperative assessments will be conducted , similarly for control group standard practice will be performed and their intraoperative and postoperative bleeding will be assed. |