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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Bronchoscopy Biopsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tranexamic acid

tranexamic acid will be administrated using the bronchoscope

Group Type EXPERIMENTAL

tranexamic acid

Intervention Type DRUG

saline

the saline will be administrated using an infusion during the biopsy.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type DRUG

Interventions

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tranexamic acid

Intervention Type DRUG

saline

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Liran Levy

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

Responsibility Role SPONSOR_INVESTIGATOR