Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05648656
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-12-02
Brief Title:
TXA Nebulization for the Treatment of Hemoptysis
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PGIMER
Study Overview
Official Title:
Efficacy of TXA Nebulization for the Treatment of Hemoptysis A Randomized Controlled Clinical Trial
Status:
RECRUITING
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TXA-NEB
Brief Summary:
Hemoptysis is a common presentation in medical emergency Prompt medical therapy bronchoscopic and endovascular procedures remains the cornerstone of management for both diagnostic as well as therapeutic purpose in hemoptysis Priority is given for medical management to achieve hemostasis and prevent aspiration as well as treatment of underlying etiology before undertaking any definitive bronchoscopic or endovascular intervention While majority of the patients are managed successfully by prompt medical therapy only the refractory cases and life-threatening hemoptysis need more definitive procedures like DSA guided bronchial artery embolization and bronchoscopic procedures like endobronchial biocompatible glue endobronchial embolization using silicone spigots endobronchial stents laser photocoagulation Tranexamic acid is an anti-fibrinolytic agent which prevent breakdown of fibrin clots thus helping in clot stabilization and controlling bleeding As a medical therapy Tranexamic Acid is used for bleeding control in hemoptysis as well as other surgical or traumatic bleeding Previously conducted institutional study comparing IV infusion of TXA to placebo in patients with sub massive hemoptysis showed results favoring TXA over placebo in terms of decreasing frequency quantity of hemoptysis duration of hospital stay and need for DSA broncoscopic surgical intervention and blood transfusion 1 While the oral and IV routes have been most commonly studied use of novel approaches like aerosolized TXA and endobronchial instillation of TXA during bronchoscopy have showed positive results in achieving hemostasis in hemoptysis 2 A recently conducted RCT to assess the effectiveness of TXA nebulization in sub-massive hemoptysis concluded that nebulized TXA is effective in reducing the frequency and quantity of hemoptysis Nebulized TXA was also found to be safe as no severe ADR was noted during its use as per previous RCT as well as multiple case reports
However because of limited number of research with small sample size and barring some case reports evidence for the use of nebulized TXA is limited in hemoptysis In hemoptysis nebulized form of TXA is supposed to reach local site of bleeding lung airway promptly at a higher concentration leading to rapid control of hemoptysis So this study has been planned to evaluate further this novel approach of TXA nebulization for the management of hemoptysis Similarly data regarding adverse drug reaction related to TXA nebulization is also limited This study will produce additional information regarding efficacy safety and ADR related to TXA nebulization
However because of limited number of research with small sample size and barring some case reports evidence for the use of nebulized TXA is limited in hemoptysis In hemoptysis nebulized form of TXA is supposed to reach local site of bleeding lung airway promptly at a higher concentration leading to rapid control of hemoptysis So this study has been planned to evaluate further this novel approach of TXA nebulization for the management of hemoptysis Similarly data regarding adverse drug reaction related to TXA nebulization is also limited This study will produce additional information regarding efficacy safety and ADR related to TXA nebulization
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None