Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2014
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2014
CompletedFirst Posted
Study publicly available on registry
August 18, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 1, 2018
May 1, 2018
5.3 years
August 12, 2014
May 30, 2018
Conditions
Outcome Measures
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.
participants will be followed for the duration of hospital stay, an expected average of one day
Secondary Outcomes (1)
amount of erythrocytes
participants will be followed for the duration of hospital stay, an expected average of one day
Study Arms (2)
tranexamic acid
EXPERIMENTALtranexamic acid will be administrated using the bronchoscope
saline
PLACEBO COMPARATORthe saline will be administrated using an infusion during the biopsy.
Interventions
Eligibility Criteria
You may qualify if:
- Patient that are candidates to endobronchial or transcronchial biopsy
You may not qualify if:
- S/P MI or CVA or PE or DVT .
- S/P thrombophilia.
- Patients under coagulation therpay
- Chronic Renal Failure
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Liran Levylead
Study Sites (1)
Hadassah Medical Organization
Jerusalem, 91120, Israel
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Neville Berkman, MD
Hadassah Medical Organization
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
Study Record Dates
First Submitted
August 12, 2014
First Posted
August 18, 2014
Study Start
September 1, 2014
Primary Completion
January 1, 2020
Study Completion
December 1, 2020
Last Updated
June 1, 2018
Record last verified: 2018-05