TXA Nebulization for the Treatment of Hemoptysis

NCT05648656 | Unknown Phase 3 DMC

• 1 other identifier: INT/IEC/2021/SPL-1634
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemoptysis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Adverse drug events

  48 hours

• Resolution of hemoptysis

  48 Hours

• Need for intervention

  48 Hours

• Need for blood transfusion

  48 Hours

• Duration of hospital stay

  4 weeks

Study Arms (2)

TXA

ACTIVE COMPARATOR

Nebulization with TXA 500mg/ 5mL 8 hourly for 2 days.

Drug: TXA Nebulization

Control

PLACEBO COMPARATOR

Nebulization with 0.9%normal saline 5mL 8 hourly for 2 days

Other: 0.9% NS Nebulization

Interventions

TXA Nebulization DRUG

Nebulization with TXA 500mg/ 5mL 8 hourly for 2 days plus standard care of therapy

TXA

0.9% NS Nebulization OTHER

Nebulization with 0.9% normal saline (NS) 5mL 8 hourly for 2 days plus standard care of therapy

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Post Graduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Related Publications (1)

• Agrawal A, Dhibar DP, Prakash A, Sreedhara BC, Muthu V, Pannu AK. Efficacy and safety of tranexamic acid nebulization to control bleeding of hemoptysis: The TXA-NEB randomized controlled clinical trial. Indian J Pharmacol. 2025 Nov 1;57(6):392-400. doi: 10.4103/ijp.ijp_824_25. Epub 2025 Oct 12.

  PMID: 41221568 DERIVED

MeSH Terms

Conditions

Hemoptysis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Deba P Dhibar, MD

CONTACT

9530881462; drdeba_prasad@yahoo.co.in

Aman Agrawal, MBBS

CONTACT

9602166504; amanagrawal.sms96@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 13, 2022
• Study Start: February 3, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)