TXA Nebulization for the Treatment of Hemoptysis (TXA-NEB)

Efficacy of TXA Nebulization for the Treatment of Hemoptysis: A Randomized Controlled Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hemoptysis
• Intervention / Treatment: Drug: TXA Nebulization; Other: 0.9% NS Nebulization

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Deba P Dhibar, MD; Phone Number: 9530881462; Email: drdeba_prasad@yahoo.co.in
• Study Contact Backup: Name: Aman Agrawal, MBBS; Phone Number: 9602166504; Email: amanagrawal.sms96@gmail.com

Study Locations

• India
  • Chandigarh, India, 160012
    • Recruiting
    • Post Graduate Institute of Medical Education and Research
    • Contact: Deba Prasad dhibar, MD; Phone Number: +911722756670; Email: dhibar.dp@pgimer.edu.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All cases of active hemoptysis
• irrespective of gender
• age≥ 18 years

Exclusion Criteria:

• Massive hemoptysis
• Pregnancy
• Drug allergy to TXA4
• Renal failure
• Receiving Oral Contraceptive Pills.
• Already on blood thinner
• Not willing for consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TXA; Nebulization with TXA 500mg/ 5mL 8 hourly for 2 days.	Drug: TXA Nebulization; Nebulization with TXA 500mg/ 5mL 8 hourly for 2 days plus standard care of therapy
Placebo Comparator: Control; Nebulization with 0.9%normal saline 5mL 8 hourly for 2 days	Other: 0.9% NS Nebulization; Nebulization with 0.9% normal saline (NS) 5mL 8 hourly for 2 days plus standard care of therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of hemoptysis	Number of episode of hemoptysis per day will be compared at baseline and day 2 (48 hours)	48 hours
Quantity of hemoptysis	Through collection of expectorated blood, quantityofhemoptysis per day will be compared at baseline and day2 (48hours) .	48 hours
Visual analogue scale (VAS)	Visual subjective assessment by the patient will be used to compare the amount of hemoptysis at baseline and day 2 (48 hours). VAS will be presented to the patients as a 100 mm line anchored by description with 'no-hemoptysis' at one end and 'worst imaginable hemoptysis' on the other end. Patients will be asked to mark a point on the 100 mm line to indicate the severity. A millimeter scale will be used to measure the score and this will provide 0-100 levels of hemoptysis and the score increases with increasing severity.	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse drug events	Frequency/number of adverse drug events will be compared between the groups.	48 hours
Resolution of hemoptysis	Resolution of hemoptysis is defined as no episode of hemoptysis containing fresh blood sustained for at least 48 hours following cessation of hemoptysis. The rate of resolution of hemoptysis will be compared between the groups.	48 Hours
Need for intervention	The overall the rate of the need for therapeutic interventional procedures (BAE, bronchoscopic procedures), to achieve hemostasis, will be compared between the study and control group.	48 Hours
Need for blood transfusion	The percentage of patients requiring blood transfusion as well as the mean number of PRBCs transfused will be compared between the groups.	48 Hours
Duration of hospital stay	The total duration of hospital stay (from the day of admission to the day of discharge or death) will be compared between both the groups.	4 weeks
Mortality	All patients will be followed up at day 28, physically or telephonically to assess the mortality as well as their well-being. The rate of mortality will be compared between the groups.	4 weeks
Recurrence of hemoptysis	Recurrence will be defined as fresh episode of hemoptysis after resolution during 28 days follow-up. The rate of recurrence of hemoptysis will be compared between the groups.	4 weeks

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: December 2, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Estimate): December 13, 2022

Study Record Updates

• Last Update Posted (Estimate): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Hemorrhage; Signs and Symptoms, Respiratory; Hemoptysis
• Other Study ID Numbers: INT/IEC/2021/SPL-1634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No