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

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.

Study Overview

• Status: Unknown
• Conditions: Bronchoscopy Biopsy
• Intervention / Treatment: Drug: tranexamic acid; Drug: saline

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liran Levy, MD; Phone Number: 6475189676; Email: dlev330@hadassah.org.il
• Study Contact Backup: Name: Liran Levy, MD; Phone Number: 6475189676; Email: levyliran361@gmail.com

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Recruiting
    • Hadassah Medical Organization
    • Contact: Liran Levy, MD; Phone Number: 6475189676; Email: dlev330@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tranexamic acid; tranexamic acid will be administrated using the bronchoscope	Drug: tranexamic acid
Placebo Comparator: saline; the saline will be administrated using an infusion during the biopsy.	Drug: saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Liran Levy
• Investigators: Study Director: Neville Berkman, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 12, 2014
• First Submitted That Met QC Criteria: August 15, 2014
• First Posted (Estimate): August 18, 2014

Study Record Updates

• Last Update Posted (Actual): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 30, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 0321-14