Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01496196
Other study ID # 0096-11-MMC
Secondary ID
Status Recruiting
Phase Phase 3
First received December 18, 2011
Last updated April 12, 2015
Start date January 2012
Est. completion date February 2016

Study information

Verified date December 2011
Source Meir Medical Center
Contact David Shitrit, Dr.
Phone 09-7471556
Email Davids3@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date February 2016
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Israel Pulmonary department, Meir Medical Center Kfar Saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary bleeding stops 1 year No