Comparing Tranexamic Acid and Adrenaline for Preventing Bleeding During Bronchoscopy
Prophylactic Tranexamic Acid Versus Adrenaline for Bleeding Prevention During Flexible Bronchoscopy: a Double Blind, Randomized Controlled Trial
This study is testing whether tranexamic acid or adrenaline can help prevent bleeding during bronchoscopy procedures to make them safer for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 840 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Clinical Hospital Centre Zagreb Academic / other |
| Locations | 1 site (Zagreb) |
| Trial ID | NCT06145191 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of tranexamic acid and adrenaline in preventing bleeding during diagnostic bronchoscopy procedures. Both medications are applied topically to assess their ability to reduce the incidence of bleeding complications, which can impact the quality and outcomes of the procedure. The study aims to determine which of the two agents is more effective in maintaining hemostasis and improving patient safety during bronchoscopy. Participants will be randomly assigned to receive either tranexamic acid, adrenaline, or a placebo.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for diagnostic bronchoscopy with sampling procedures who can provide informed consent.
Not a fit: Patients with contraindications for bronchoscopy, coagulopathy, or those on certain anticoagulant therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing bronchoscopy by reducing the risk of bleeding complications.
How similar studies have performed: Previous studies have shown that both tranexamic acid and adrenaline can be effective in managing bleeding during bronchoscopy, suggesting that this approach has potential based on existing evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All patients undergoing diagnostic bronchoscopy with sampling (including transbronchial biopsy, endobronchial forceps biopsy, brushing, transbronchial needle aspiration) * Signed informed consent Exclusion Criteria: * Any existing contraindication for diagnostic bronchoscopy * Coagulopathy (PV INR \> 1.3) * Thrombocytopenia (\<50x10\*9 or anemia (Hgb \<80 g/L) * DOAC, LMWH or antiplatelet drug therapy * Thrombophilia, history of pulmonary embolism or deep vein thrombosis * Contraindication for endobronchial application of adrenaline * Uncontrolled coronary artery disease, cerebrovascular disease or arrhythmia * Uncontrolled pulmonary hypertension * Cardiovascular decompensation * Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)
Where this trial is running
Zagreb
- University Hospital Centre Zagreb — Zagreb, Croatia (Recruiting)
Study contacts
- Study coordinator: Sonja Badovinac, MD, PhD
- Email: sonjabadovinac1@gmail.com
- Phone: 00385(1)2385129
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.