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Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

Phase 3
Active, not recruiting
Conditions
Hemorrhage Lung
Endobronchial Mass
Registration Number
NCT06266546
Lead Sponsor
Youssef Yammine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Inclusion Criteria:<br><br> - Age =18<br><br> - Signed informed consent<br><br> - Receiving a transbronchial cryobiopsy<br><br>Exclusion Criteria:<br><br> - Age below 18<br><br> - Pregnancy<br><br> - Bleeding diathesis (INR >1.5 or known hematological problems)<br><br> - Subarachnoid hemorrhage<br><br> - Any active bleeding (any site)<br><br> - Decompensated liver disease<br><br> - Active intravascular clotting<br><br> - Prior VTE<br><br> - On oral contraceptive therapy<br><br> - Platelet count less than 50,000<br><br> - Use of antiplatelet medication other than low-dose aspirin within 5 days of<br> procedure<br><br> - Use of therapeutic anticoagulation within the last 24 hrs<br><br> - Known severe pulmonary hypertension (pulmonary artery systolic pressure > 60 mmHg)<br><br> - Chronic renal failure (estimated GFR below 30 mL/min)<br><br> - Allergy or hypersensitivity to tranexamic acid or any of its ingredients<br><br> - Prisoners<br><br> - Comfort care planned or initiated within 72 hours of admission

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Major Hemorrhage
Secondary Outcome Measures
NameTimeMethod
Early termination of the procedure due to bleeding;Rate of intermediate hemorrhage;Rate of minor hemorrhage;Inadequate tissue sampling due to bleeding;Graded use of other measures to control bleeding (not prophylactic);Unplanned hospital admission for bleeding complications;Acute cardiovascular side effects;All cause 28 day mortality
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