NCT04771923

Brief Summary

Endobronchial bleeding is a relatively common complication of diagnostic bronchoscopy. Both tranexamic acid and adrenaline are used topically for the control of endobronchial bleeding. The aim of this study is to compare the efficacy of tranexamic acid with adrenaline in controlling iatrogenic endobronchial bleeding after diagnostic bronchoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

February 22, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

February 18, 2021

Last Update Submit

February 22, 2022

Conditions

BleedingHemoptysis

Keywords

BronchoscopyTranexamic acidAdrenaline

Outcome Measures

Primary Outcomes (1)

  • Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm

    Bleeding control is assessed by the bronchoscopist by visual confirmation of clot formation.

    Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.

Secondary Outcomes (5)

  • Number (N) of tranexamic acid/adrenaline applications necessary to control endobronchial bleeding

    Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..

  • Number (N) of recurrent bleeding episodes after instillation of tranexamic acid/adrenaline

    During the first 24 hours immediately after the individual procedure (bronchoscopy).

  • Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm in relation to the severity of bleeding.

    Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application..

  • Percentage (%) of successfully controlled iatrogenic endobronchial bleeding in each arm

    Until the end of the individual procedure (bronchoscopy), up to 1 minute after each drug application.

  • To compare number (N) of adverse events in each arm

    During and up to 1 month after the procedure (bronchoscopy).

Study Arms (2)

Tranexamic acid

EXPERIMENTAL
Drug: Tranexamic acid

Adrenaline

EXPERIMENTAL
Drug: Adrenaline

Interventions

Tranexamic acidDRUG

Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.

Tranexamic acid
AdrenalineDRUG

Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.

Adrenaline

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with endobronchial bleeding during diagnostic bronchoscopy that was not successfully controlled with cold (4°C) normal saline (3 aliquots of 5ml during 60sec)

You may not qualify if:

  • Any patient with a contraindication for diagnostic flexible bronchoscopy
  • Coagulopathy (PV INR \>1.3)
  • Thrombocytopenia (\<50x10\^9) or anemia (hgb \<80 g/L)
  • Direct oral anticoagulant, low molecular weight heparin or antiplatelet drug therapy
  • Thrombophilia, history of pulmonary embolism or deep vein thrombosis
  • Contraindication for endobronchial application of adrenaline
  • Coronary heart disease, cerebrovascular disease, history of tachyarrhythmia
  • Uncontrolled pulmonary hypertension
  • Cardiovascular decompensation
  • Severe hypoxia (PaO2 \<60mmHg, SaO2 \<90% with an FiO2 \>=60%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (1)

  • Badovinac S, Glodic G, Sabol I, Dzubur F, Makek MJ, Baricevic D, Korsic M, Popovic F, Srdic D, Samarzija M. Tranexamic Acid vs Adrenaline for Controlling Iatrogenic Bleeding During Flexible Bronchoscopy: A Double-Blind Randomized Controlled Trial. Chest. 2023 Apr;163(4):985-993. doi: 10.1016/j.chest.2022.10.013. Epub 2022 Oct 21.

    PMID: 36273651DERIVED

MeSH Terms

Conditions

HemorrhageHemoptysis

Interventions

Tranexamic AcidEpinephrine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsEthanolaminesAmino AlcoholsAlcoholsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 18, 2021

First Posted

February 25, 2021

Study Start

February 22, 2021

Primary Completion

February 4, 2022

Study Completion

February 4, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02

Locations

CR(1)