Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy

NCT06266546 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: CRYOTXA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhage Lung; Endobronchial Mass

Keywords

Transbronchial biopsy; Tranexamic Acid (TXA); Hemorrhage; Prophylaxis

Outcome Measures

Primary Outcomes (1)

• Major Hemorrhage

  Ordinal scale of less severe to most severe 1\. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage

  up to 2 hours post procedure

Secondary Outcomes (8)

• 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

• Graded use of other measures to control bleeding (not prophylactic)

  up to 2 hours post procedure

Study Arms (2)

Intervention

EXPERIMENTAL

Prophylactic TXA arm

Drug: Tranexamic acid

Control

NO INTERVENTION

Data collected retrospectively from patients undergoing the same procedure one year prior to the study initiation

Interventions

Tranexamic acid DRUG

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Signed informed consent
• Receiving a transbronchial cryobiopsy

You may not qualify if:

• 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

Sponsors & Collaborators

• Youssef Yammine: lead

Study Sites (1)

Ascension Via Christi

Wichita, Kansas, 67214, United States

Location

Related Publications (8)

• Babiak A, Hetzel J, Krishna G, Fritz P, Moeller P, Balli T, Hetzel M. Transbronchial cryobiopsy: a new tool for lung biopsies. Respiration. 2009;78(2):203-8. doi: 10.1159/000203987. Epub 2009 Feb 21.

  PMID: 19246874 BACKGROUND

• Hetzel J, Eberhardt R, Petermann C, Gesierich W, Darwiche K, Hagmeyer L, Muche R, Kreuter M, Lewis R, Ehab A, Boeckeler M, Haentschel M. Bleeding risk of transbronchial cryobiopsy compared to transbronchial forceps biopsy in interstitial lung disease - a prospective, randomized, multicentre cross-over trial. Respir Res. 2019 Jul 5;20(1):140. doi: 10.1186/s12931-019-1091-1.

  PMID: 31277659 BACKGROUND

• Bendstrup E, Kronborg-White S, Poletti V, Folkersen B, Voldby N, Rasmussen TR. Careful Planning Reduces Cryobiopsy Complications. Ann Am Thorac Soc. 2017 Jul;14(7):1229. doi: 10.1513/AnnalsATS.201703-196LE. No abstract available.

  PMID: 28665702 BACKGROUND

• Cai J, Ribkoff J, Olson S, Raghunathan V, Al-Samkari H, DeLoughery TG, Shatzel JJ. The many roles of tranexamic acid: An overview of the clinical indications for TXA in medical and surgical patients. Eur J Haematol. 2020 Feb;104(2):79-87. doi: 10.1111/ejh.13348. Epub 2019 Dec 16.

  PMID: 31729076 BACKGROUND

• Zhou GW, Zhang W, Dong YC, Huang HD, Hu C, Sun J, Jin F, Gu Y, Li Q, Li S. Flexible bronchoscopy-induced massive bleeding: A 12-year multicentre retrospective cohort study. Respirology. 2016 Jul;21(5):927-31. doi: 10.1111/resp.12784. Epub 2016 Apr 8.

  PMID: 27061330 BACKGROUND

• Pabinger I, Fries D, Schochl H, Streif W, Toller W. Tranexamic acid for treatment and prophylaxis of bleeding and hyperfibrinolysis. Wien Klin Wochenschr. 2017 May;129(9-10):303-316. doi: 10.1007/s00508-017-1194-y. Epub 2017 Apr 21.

  PMID: 28432428 BACKGROUND

• Marquez-Martin E, Vergara DG, Martin-Juan J, Flacon AR, Lopez-Campos JL, Rodriguez-Panadero F. Endobronchial administration of tranexamic Acid for controlling pulmonary bleeding: a pilot study. J Bronchology Interv Pulmonol. 2010 Apr;17(2):122-5. doi: 10.1097/LBR.0b013e3181dc8c17.

  PMID: 23168726 BACKGROUND

• Kuint R, Levy L, Cohen Goichman P, Huszti E, Abu Rmeileh A, Shriki O, Abutbul A, Fridlender ZG, Berkman N. Prophylactic use of tranexamic acid for prevention of bleeding during transbronchial lung biopsies - A randomized, double-blind, placebo-controlled trial. Respir Med. 2020 Nov;173:106162. doi: 10.1016/j.rmed.2020.106162. Epub 2020 Sep 21.

  PMID: 32979620 BACKGROUND

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The study will be a prospective, single-arm, non-randomized trial

Study Record Dates

• First Submitted: January 10, 2024
• First Posted: February 20, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

US (1)