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Status unknownNCT02219152Updated Jun 1, 2018

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

A Phase 2 interventional study of tranexamic acid and saline in Bronchoscopy Biopsy, sponsored by Liran Levy. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by Liran Levy · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bronchoscopy Biopsy
03

In context

Lead sponsor

This is the only study on the registry with Liran Levy as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patient that are candidates to endobronchial or transcronchial biopsy

Exclusion criteria

Exclusion Criteria:

  • S/P MI or CVA or PE or DVT .
  • S/P thrombophilia.
  • Patients under coagulation therpay
  • Chronic Renal Failure
  • Pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • 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

Interventions

  • Drugtranexamic acid
  • Drugsaline
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will be followed for the duration of hospital stay, an expected average of one day

Secondary outcomes

  1. amount of erythrocytes

    amount of erythrocytes by multiplying the Hematocrit and blood volume

    Time frame: participants will be followed for the duration of hospital stay, an expected average of one day

07

Study locations

1 of 1 sites recruiting
  • Hadassah Medical Organization
    Jerusalem, 91120, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02219152
Lead sponsor
Liran Levy
Responsible party
Liran Levy (Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study, Hadassah Medical Organization) — Sponsor-investigator
First posted
Aug 18, 2014
Start date
Sep 2014
Primary completion
Jan 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Jun 1, 2018

Study contacts

Liran Levy, MD
Contact
dlev330@hadassah.org.il
6475189676
Liran Levy, MD
Contact
levyliran361@gmail.com
6475189676
Neville Berkman, MD
study director · Hadassah Medical Organization

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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