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

Phase 2

• Conditions: Bronchoscopy Biopsy
• Interventions: Drug: tranexamic acid; Drug: saline

• Registration Number: NCT02219152
• Lead Sponsor: Liran Levy

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-08-15
• Study First Posted: 2014-08-18
• Study Start: 2014-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-30
• Last Update Posted: 2018-06-01
• Primary Completion: 2020-01
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tranexamic acid	tranexamic acid	tranexamic acid will be administrated using the bronchoscope
saline	saline	the saline will be administrated using an infusion during the biopsy.

Primary Outcome Measures

Name	Time	Method
amount of bleeding	participants will be followed for the duration of hospital stay, an expected average of one day	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.

Secondary Outcome Measures

Name	Time	Method
amount of erythrocytes	participants will be followed for the duration of hospital stay, an expected average of one day	amount of erythrocytes by multiplying the Hematocrit and blood volume

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel