Topical Instillation of Tranexamic Aacid in Bronchoscopy to Decrease Bleeding During Entobronchial & Transbronchial Biopsiy: a Prospective Double Blind Placebo Controlled Study
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Liran Levy
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- amount of bleeding
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
tranexamic acid
tranexamic acid will be administrated using the bronchoscope
Intervention: tranexamic acid (Drug)
saline
the saline will be administrated using an infusion during the biopsy.
Intervention: saline (Drug)
Outcomes
Primary Outcomes
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 Outcomes
- amount of erythrocytes(participants will be followed for the duration of hospital stay, an expected average of one day)
Investigators
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