Complications Surgical, Lung Transplant
Conditions
Brief summary
To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.
Detailed description
Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practice, topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage. The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. A finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. It therefore has the potential to change clinical practice and standardize bronchoscopy procedures.
Interventions
DRUGTranexamic Acid
Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients
OTHERSaline (placebo)
Topical Saline (placebo) administered as endobronchial topical application prior to performing transbronchial biopsies in lung transplant recipients.
Sponsors
Corewell Health West
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bleeding Risk | up to 1 hour | Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time Reduction | up to 1 hour | Procedure times will be recorded for both the tranexamic acid and the control saline group. |
| Greater yield in tissue samples | up to 1 hour | This will be measured by the number of pieces of tissue from the pathology report |
Countries
United States
Outcome results
None listed