The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis

NCT ID: NCT01496196

Last Updated: 2015-04-14

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-02-29

Brief Summary

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Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that varies from blood-streaking of sputum to coughing up large amounts of pure blood.

Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.

The most common site of bleeding is the tracheobronchial tree, which can be affected by inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial arteries, which originate either from aorta or from intercostal arteries, and are part of the high-pressure systemic circulation, are the source of bleeding in bronchitis or bronchiectasis or endo bronchial tumors.

Detailed Description

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Conditions

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Hemoptisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tranexamic acid-500 mg/5 ml 3-4 times a day

tranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day

Group Type ACTIVE_COMPARATOR

tranexamic acid

Intervention Type DRUG

500 mg/5 ml 3-4 times a day

tranexamic

placebo arm

Group Type PLACEBO_COMPARATOR

tranexamic acid

Intervention Type DRUG

500 mg/5 ml 3-4 times a day

Interventions

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tranexamic acid

500 mg/5 ml 3-4 times a day

Intervention Type DRUG

tranexamic acid

500 mg/5 ml 3-4 times a day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age \> 18
* Hemodynamicaly stable
* Hemoptysis of varying etiologies
* Coumadin treatment will be switched to clexane or heparine

Exclusion Criteria

* Age \< 18
* Hemodinamicaly unstable
* Massive hemoptysis ( \> 200 ml / day)
* Renal failure: creatinine \> 3, renal replacement treatment
* Hepatic failure: bilirubin \> 2 mg/dl, AST \> 3 of upper normal limit level
* Coagulation disorders, INR\> 2.
* Hypesensitivity to tranexamic acid
* Pregnant woman
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Shitrit, Dr.

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center, Kfar Saba, Israel

Locations

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Pulmonary department, Meir Medical Center

Kfar Saba, Israel, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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David Shitrit, Dr.

Role: CONTACT

09-7471556

Facility Contacts

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David Shitrit, Dr.

Role: primary

09-7471556

References

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Wand O, Guber E, Guber A, Epstein Shochet G, Israeli-Shani L, Shitrit D. Inhaled Tranexamic Acid for Hemoptysis Treatment: A Randomized Controlled Trial. Chest. 2018 Dec;154(6):1379-1384. doi: 10.1016/j.chest.2018.09.026. Epub 2018 Oct 12.

Reference Type DERIVED
PMID: 30321510 (View on PubMed)

Other Identifiers

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0096-11-MMC

Identifier Type: -

Identifier Source: org_study_id

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