Endobronchial Mass, Hemorrhage Lung
Conditions
Keywords
Transbronchial biopsy, Tranexamic Acid (TXA), Hemorrhage, Prophylaxis
Brief summary
Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.
Detailed description
Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual. The study will be a prospective, single-arm, non-randomized trial Location: Ascension Via Christi Saint Francis. Medication: Tranexamic acid 500 milligrams per 5 mL ampule (Baxter, NDC 43066-008-01) mixed with 10 mL normal saline. Patients: A total of 100 patients will be enrolled in the study.
Interventions
DRUGTranexamic acid
Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual.
Sponsors
Youssef Yammine
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study will be a prospective, single-arm, non-randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Signed informed consent * Receiving a transbronchial cryobiopsy
Exclusion criteria
* Age below 18 * Pregnancy * Bleeding diathesis (INR \>1.5 or known hematological problems) * Subarachnoid hemorrhage * Any active bleeding (any site) * Decompensated liver disease * Active intravascular clotting * Prior VTE * On oral contraceptive therapy * Platelet count less than 50,000 * Use of antiplatelet medication other than low-dose aspirin within 5 days of procedure * Use of therapeutic anticoagulation within the last 24 hrs * Known severe pulmonary hypertension (pulmonary artery systolic pressure \> 60 mmHg) * Chronic renal failure (estimated GFR below 30 mL/min) * Allergy or hypersensitivity to tranexamic acid or any of its ingredients * Prisoners * Comfort care planned or initiated within 72 hours of admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major Hemorrhage | up to 2 hours post procedure | Ordinal scale of less severe to most severe 1\. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early termination of the procedure due to bleeding | up to 2 hours post procedure | — |
| Rate of intermediate hemorrhage | up to 2 hours post procedure | — |
| Rate of minor hemorrhage | up to 2 hours post procedure | — |
| Inadequate tissue sampling due to bleeding | up to 2 hours post procedure | y/n |
| Graded use of other measures to control bleeding (not prophylactic) | up to 2 hours post procedure | In order of escalating interventions (severity): use of iced saline, epinephrine, mainstem intubation, embolization |
| Unplanned hospital admission for bleeding complications | 2 hours post procedure uo to 30 days post procedure | hospital readmission |
| Acute cardiovascular side effects | up to 30 days post procedure | thrombosis events |
| All cause 28 day mortality | up to 28 days post procedure | morality rate |
Countries
United States
Outcome results
None listed