Prophylactic Tranexamic Acid Versus Adrenaline During Flexible Bronchoscopy

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

1013 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-18

Study Completion Date

2025-03-28

Brief Summary

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Endobronchial bleeding is a common complication of bronchoscopy. Major bleeding, although rare, can be life threatening and often requires advanced therapeutic interventional pulmonary procedures which are not widely available. Minor bleeding can negatively impact outcomes such as diagnostic yield, sample size and bronchoscopy duration. Both adrenaline and tranexamic acid are successfully used topically for hemostasis during diagnostic bronchoscopy. The aim of this study is to evaluate the efficacy of prophylactically applied adrenaline and tranexamic acid in bleeding prevention during diagnostic bronchoscopy.

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Detailed Description

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Conditions

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Bleeding Hemoptysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Multiple arm randomized controlled trial

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tranexamic acid

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling

Adrenaline

Group Type EXPERIMENTAL

Adrenaline

Intervention Type DRUG

Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling

Interventions

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Tranexamic acid

Prophylactic topical application (1x) of tranexamic acid (100mg, 2ml, room temperature) before sampling

Intervention Type DRUG

Adrenaline

Prophylactic topical application (1x) of adrenaline (1:10.000, 2ml, room temperature) before sampling

Intervention Type DRUG

Placebo

Prophylactic topical application (1x) of placebo (0.9% NaCl, 2ml, room temperature) applied before sampling

Intervention Type DRUG

Other Intervention Names

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0.9% NaCl

Eligibility Criteria

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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%)

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No