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

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ClinicalTrials.gov Identifier: NCT02219152
Recruitment Status : Recruiting
First Posted : August 18, 2014
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Liran Levy, Hadassah Medical Organization

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.


Condition or disease Intervention/treatment Phase
Bronchoscopy Biopsy Drug: tranexamic acid Drug: saline Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Actual Study Start Date : September 2014
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Bleeding

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



Primary Outcome Measures :
  1. amount of bleeding [ Time Frame: 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 :
  1. amount of erythrocytes [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02219152


Contacts
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Contact: Liran Levy, MD 6475189676 dlev330@hadassah.org.il
Contact: Liran Levy, MD 6475189676 levyliran361@gmail.com

Locations
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Israel
Hadassah Medical Organization Recruiting
Jerusalem, Israel, 91120
Contact: Liran Levy, MD    6475189676    dlev330@hadassah.org.il   
Sponsors and Collaborators
Liran Levy
Investigators
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Study Director: Neville Berkman, MD Hadassah Medical Organization
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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
ClinicalTrials.gov Identifier: NCT02219152    
Other Study ID Numbers: 0321-14
First Posted: August 18, 2014    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants