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TXA Nebulization for the Treatment of Hemoptysis

NCT ID: NCT05648656

Last Updated: 2022-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-03

Study Completion Date

2023-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hemoptysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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TXA

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

Group Type ACTIVE_COMPARATOR

TXA Nebulization

Intervention Type DRUG

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

Control

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

Group Type PLACEBO_COMPARATOR

0.9% NS Nebulization

Intervention Type OTHER

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

Interventions

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TXA Nebulization

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

Intervention Type DRUG

0.9% NS Nebulization

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All cases of active hemoptysis
* irrespective of gender
* ageā‰„ 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

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Deba Prasad Dhibar

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Post Graduate Institute of Medical Education and Research

Chandigarh, , India

Site Status RECRUITING

Countries

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India

Central Contacts

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Deba P Dhibar, MD

Role: CONTACT

Phone: 9530881462

Email: [email protected]

Aman Agrawal, MBBS

Role: CONTACT

Phone: 9602166504

Email: [email protected]

Facility Contacts

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Deba Prasad dhibar, MD

Role: primary

Other Identifiers

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INT/IEC/2021/SPL-1634

Identifier Type: -

Identifier Source: org_study_id