The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis

• Sponsor: Meir Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01496196
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hemoptisis	Drug: tranexamic acid; Drug: tranexamic acid	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 2012
• Anticipated Primary Completion Date: Jan 1, 2016
• Anticipated Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: tranexamic acid; 500 mg/5 ml 3-4 times a day
Placebo Comparator: tranexamic placebo arm	Drug: tranexamic acid; 500 mg/5 ml 3-4 times a day

Outcome Measures

Primary Outcome Measures

1. bleeding stops [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pulmonary department, Meir Medical Center	Kfar Saba		Israel	972

Sponsors and Collaborators

• Meir Medical Center

Investigators

• Principal Investigator: David Shitrit, Dr., Meir Medical Center, Kfar Saba, Israel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Meir Medical Center
• ClinicalTrials.gov Identifier: NCT01496196
• Other Study ID Numbers: 0096-11-MMC
• First Posted: Dec 21, 2011
• Last Update Posted: Apr 14, 2015
• Last Verified: Dec 1, 2011

• Keywords provided by Meir Medical Center: hemoptisis; bleeding; tranexamic acid
• Additional relevant MeSH terms: Tranexamic Acid

Study Results

No Results Posted as of Apr 14, 2015