Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

Phase 3

Active, not recruiting

• Conditions: Hemorrhage Lung; Endobronchial Mass
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT06266546
• Lead Sponsor: Youssef Yammine

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.

Study Timeline

• Study First Submitted: 2024-01-10
• Study First Submitted QC: 2024-02-15
• Study First Posted: 2024-02-20
• Study Start: 2024-03-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-21
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Tranexamic acid	Prophylactic TXA arm

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Rate of minor hemorrhage	up to 2 hours post procedure
Acute cardiovascular side effects	up to 30 days post procedure	thrombosis events
Early termination of the procedure due to bleeding	up to 2 hours post procedure
Rate of intermediate hemorrhage	up to 2 hours post procedure
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
All cause 28 day mortality	up to 28 days post procedure	morality rate
Inadequate tissue sampling due to bleeding	up to 2 hours post procedure	y/n

Trial Locations

Locations (1)

Ascension Via Christi; 🇺🇸 Wichita, Kansas, United States