| CTRI Number |
CTRI/2019/04/018352 [Registered on: 01/04/2019] Trial Registered Prospectively |
| Last Modified On: |
01/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Is Use of Tranexamic acid in Adenotonsillectomy in redusing the amount of blood loss during surgery? |
|
Scientific Title of Study
|
Effect of preoperative systemic Tranexamic acid on the amount of blood loss in Tonsillectomy,Adenotonsillectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| trial not registered elsewhere |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajarajeswari Nalamate |
| Designation |
Assistant Professor |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
department of ENT,Pondicherry institute of medical sciences,ganapathi chettikulam,kalapet,pondicherry
ganapathichettikulam,kalapet,pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9488776655 |
| Fax |
|
| Email |
rajisampathporal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajarajeswari Nalamate |
| Designation |
Assistant Professor |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
department of ENT,Pondicherry institute of medical sciences,ganapathi chettikulam,kalapet,pondicherry
ganapathichettikulam,kalapet,pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9488776655 |
| Fax |
|
| Email |
rajisampathporal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajarajeswari Nalamate |
| Designation |
Assistant Professor |
| Affiliation |
pondicherry institute of medical sciences |
| Address |
department of ENT,Pondicherry institute of medical sciences,ganapathi chettikulam,kalapet,pondicherry
ganapathichettikulam,kalapet,pondicherry
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9488776655 |
| Fax |
|
| Email |
rajisampathporal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pondicherry Institute of Medical Sciences,Ganapathichettikulam, Kalapet, Pondicherry 605014 |
|
|
Primary Sponsor
|
| Name |
pondicherry institute of medical sciences |
| Address |
ganapathichettikulam ,kalapet,pondicherry.605003 |
| Type of Sponsor |
Private 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 Rajarajeswari |
Pondicherry Institute of Medical Sciences |
Department of ENT,Pondicherry Institue of Medical Sciences, Ganapathichettikulam, Kalapet,Pondicherry 605014
605013
Pondicherry
PONDICHERRY |
9488776655
rajisampathporal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: J350||Chronic tonsillitis and adenoiditis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tranexamic acid |
preoperative systemic Tranexamic acid versus placebo(saline) during tonsillectomy,adenotonsillectomy, to compare the blood loss between the two agents. Injection Tranexamic acid in the dose of 15mg/kg body weight diluted to 10ml is given as slow Intravenous injection over a period of 10 minutes immediately after intubation,single dose |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
all patients posted for tonsillectomy, adenotonsillectomy, between age of 3 and 40 years, with indications like recurrent / chronic tonsillitis / adenoiditis/ hypertrophic tonsils and adenoids causing osas |
|
| ExclusionCriteria |
| Details |
1.allergy to tranexamic acid
2. bleeding disorders
3. age <3 and >40 years
4. suspected case of nasopharyngeal or tonsillar malignancy, lymphoproliferative disorders
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine the efficacy of preoperative intravenous tranexamic acid on intra operative blood loss in tonsillectomy, adenotonsillectomy |
At the time of extubation following Tonsillectomy,Adenotonsillectomy,amount of total blood loss is estimated |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
effect on post operative bleeding episodes
to see for any side effects of pre operative iv tranexamic acid in patients undergoing tonsillectomy/ adenotonsillectomy |
10 days post operative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/04/2019 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
non yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
the study aims on assessing the preoperative use of iv tranexamic acid in reducing the intraoperative blood loss during tonsillectomy and adenotonsillectomy done by cold steel dissection method as controlled to placebo. |