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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Actual Study Start Date :||September 2014|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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.
- 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
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
|Contact: Liran Levy, MDemail@example.com|
|Contact: Liran Levy, MDfirstname.lastname@example.org|
|Hadassah Medical Organization||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Liran Levy, MD 6475189676 email@example.com|
|Study Director:||Neville Berkman, MD||Hadassah Medical Organization|