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The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis

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Clalit Health Services

Status and phase

Unknown
Phase 3

Conditions

Hemoptisis

Treatments

Drug: tranexamic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT01496196
0096-11-MMC

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

tranexamic acid-500 mg/5 ml 3-4 times a day
Active Comparator group
Description:
tranexamic acid arm: inhalations of tranexamic acid 500 mg/5 ml 3-4 times a day
Treatment:
Drug: tranexamic acid
Drug: tranexamic acid
tranexamic
Placebo Comparator group
Description:
placebo arm
Treatment:
Drug: tranexamic acid
Drug: tranexamic acid

Trial contacts and locations

1

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Central trial contact

David Shitrit, Dr.

Data sourced from clinicaltrials.gov

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