Tranexamic Acid Versus Adrenaline for Controlling Iatrogenic Endobronchial Bleeding

NCT ID: NCT04771923

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2022-02-04

Brief Summary

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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.

Detailed Description

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Conditions

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Bleeding Hemoptysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tranexamic acid

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

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

Adrenaline

Group Type EXPERIMENTAL

Adrenaline

Intervention Type DRUG

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

Interventions

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Tranexamic acid

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

Intervention Type DRUG

Adrenaline

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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%)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Centre Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Goran Glodić

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type DERIVED
PMID: 36273651 (View on PubMed)

Other Identifiers

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8.1-21/20-2; 02/21AG

Identifier Type: -

Identifier Source: org_study_id

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