| CTRI Number |
CTRI/2019/05/019337 [Registered on: 24/05/2019] Trial Registered Prospectively |
| Last Modified On: |
16/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of a drug - tranexamic acid given through vapour form or injection form to patients coming to emergencycoughing out blood. |
Scientific Title of Study
Modification(s)
|
Nebulized vs Intravenous tranexamic acid in patients with
hemoptysis presenting to Emergency Department : A randomized control
study |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Praveen Aggarwal |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Emergency Medicine
AIIMS, New Delhi
South
DELHI
110023
India |
| Phone |
|
| Fax |
|
| Email |
peekay_124@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Praveen Aggarwal |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS, New Delhi |
| Address |
Praveen Aggarwal
Professor and HOD
Department of Emergency Medicine
AIIMS, New Delhi
DELHI
110023
India |
| Phone |
|
| Fax |
|
| Email |
peekay_124@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Praveen Aggarwal |
| Designation |
Professor and HOD |
| Affiliation |
AIIMS, New Delhi |
| Address |
Praveen Aggarwal
Professor and HOD
Department of Emergency Medicine
AIIMS, New Delhi
DELHI
110023
India |
| Phone |
|
| Fax |
|
| Email |
peekay_124@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Emergency Medicine, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi, Delhi 110029 |
| 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 Praveen Aggarwal |
AIIMS, New Delhi |
Emergency Department
AIIMS, New Delhi
South
DELHI |
9810090693
peekay_124@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J470||Bronchiectasis with acute lower respiratory infection, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravenous tranexamic acid arm |
The IV arm would receive 500 mg of tranexamic acid intravenously slowly
over 15 mins followed by 500mg TA iv TDS. The patients would be advised to collect hemoptysis in a
measuring cup and the amount of bleed in 12 and 24 hours
would be collected. |
| Intervention |
Nebulised tranexamic acid arm |
Nebulised arm would receive
500mg(5ml) of nebulized TA mixed with 5 ml of distilled water stat
followed by 500mg TA nebulised TDS . The osmolarity of TA is 680mOsm/Kg and when diluted with 5 ml of distilled water is 320mOsm/Kg, making iso-
osmolar to plasma. The patients would be advised to collect hemoptysis in a
measuring cup and the amount of bleed in 12 and 24 hours would be collected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adult(>18years) patients presenting to the Emergency Department with active hemoptysis. |
|
| ExclusionCriteria |
| Details |
1) Patients already received tranexamic acid before presenting to the
hospital.
2) Intubated patients on mechanical ventilation.
3) Patients with massive life-threatening hemoptysis who need to be
immediately shifted for interventional procedures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cessation of bleeding in patients presenting to ED with active
hemoptysis at 30 minutes after initiation of treatment. |
30 minutes after initiation of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Need for urgent
interventional procedures – Bronchoscopy and
bronchial artery embolization(BAE). |
Time of interventional procedure |
2. Reduction in volume of hemoptysis at 6, 12 and 24 hours after
presenting to Emergency department(ED). |
6,12 and 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/07/2019 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Parallel randomized (non- blinded) single-centered study and will be conducted at Emergency Department of All India Institute of Medical Sciences (AIIMS), New Delhi comparing the effects of nebulised vs intravenous tranexamic acid in patients with hemoptysis presenting to the emergency department. 25 patients will be recurited in each arm. The IV arm would receive 500 mg of tranexamic acid intravenously slowly over 15 mins followed by 500mg TA iv TDS and Neb. arm would receive 500mg(5ml) of nebulized TA mixed with 5 ml of distilled water stat followed by 500mg TA iv TDS . The osmolarity of TA is 680mOsm/Kg and when diluted with 5 ml of distilled water is 320mOsm/Kg, making iso-osmolar to plasma. The patients would be advised to collect hemoptysis in a measuring cup and the amount of bleed in 12 and 24 hours in both the arms would be collected. All treatment decision will be taken by the treating physician, including need for intervention. The patients who undergo intervention would be treated as intention to treat analysis.The primary outcome is Cessation of bleeding in patients presenting to ED with active hemoptysis at 30 minutes after initiation of treatment. And secondary objectives are 1. Need for urgent interventional procedures – Bronchoscopy and bronchial artery embolization(BAE). 2. Reduction in volume of hemoptysis at 6, 12 and 24 hours after presenting to Emergency department(ED).
|