Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial (Protest Trial)

2024-0552

To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.

2024-04-16

2025-04-30

2026-04-30

Early phase I

94

Inclusion Criteria: 1. Single or double lung transplant recipients 2. Patients \>18 years old 3. Willingness and ability to sign an informed consent for study participation Exclusion Criteria: 1. Platelet count (\<50k/uL) 2. INR (\>1.6) 3. Active bleeding 4. Decompensated liver disease 5. History of uremic bleeding or BUN \>50 6. Severe pulmonary hypertension (mean PA pressure \>40 mmHg on RHC or estimated PA systolic pressure \>62 mmHg on TTE within one year of procedure) 7. Known bleeding disorder 8. Allergy to TXA 9. Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention) 10. Contraindications to topical TXA 11. Pregnancy 12. Vulnerable populations 13. Adults of limited English proficiency/non-English speakers

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study design will be a single-center, randomized, double-blinded, placebo-controlled study. The control group will receive topical saline (placebo) and the experimental treatment group will receive topical Tranexamic acid (TXA active drug).', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'The investigational pharmacist will be responsible for randomizing on the day of bronchoscopy to placebo or Tranexamic acid in a 1:1 fashion using REDCap software. The pharmacist will be the only individual aware of the randomization assignment. All other study personnel will be blinded to the randomization assignment.', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 94, 'type': 'ESTIMATED'}}

2024-05-20