Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study

Bronchoscopy Biopsy Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02219152
• Other study ID #: 0321-14
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2014
• Est. completion date: December 2020

Study information

• Verified date: May 2018
• Source: Hadassah Medical Organization
• Contact: Liran Levy, MD
• Phone: 6475189676
• Email: dlev330[@]hadassah.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Bleeding during transbronchial ro endobronchial biopsy is rather a common complication.

Mostly this is an insignificant bleeding, but in 3% of the biopsies there is a substantial amount of bleeding that requires a special treatment or follow up.

The goal of this study is to examine whether submission of tranexamic acid during the biopsy could diminish the amount of bleeding.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patient that are candidates to endobronchial or transcronchial biopsy

Exclusion Criteria:

• S/P MI or CVA or PE or DVT .

• S/P thrombophilia.

• Patients under coagulation therpay

• Chronic Renal Failure

• Pregnancy

Related Conditions & MeSH terms

• Bronchoscopy Biopsy

Intervention

Drug:
• tranexamic acid

• saline

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Liran Levy

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of bleeding	amount of bleedibg that will be calculated on the basis of the difference between the amount of saline that will be injected at the bronchoscopy and the blood and fluid that will be collected in the suction tank.	participants will be followed for the duration of hospital stay, an expected average of one day
Secondary	amount of erythrocytes	amount of erythrocytes by multiplying the Hematocrit and blood volume	participants will be followed for the duration of hospital stay, an expected average of one day