Trial Outcomes & Findings for Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies (NCT NCT03126968)

Results Overview

Intra-procedural hemorrhage will be graded by the performing bronchoscopist according to the following scale: 1. No hemorrhage. 2. Mild hemorrhage - Any bleeding originating from the biopsy target airway requiring wedging of the bronchoscope or "in and out" motion in order to achieve hemostasis. 3. Moderate hemorrhage - Any bleeding originating from the biopsy target airway requiring in addition to maneuvering the bronchoscope application of iced saline or topical epinephrine or placing the patient with the bleeding lung in the dependent position. 4. Severe hemorrhage - Any bleeding originating from the biopsy target airway requiring, in addition to the above-mentioned maneuvers, early termination of the procedure or necessitating application of balloon tamponade, endotracheal intubation, application of a bronchial blocker, or use of other invasive measures to achieve hemostasis, such as bronchial artery embolization or surgical intervention.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

66 participants

Primary outcome timeframe

This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.

Results posted on

2024-08-28

Participant Flow

Eligible patients undergoing bronchoscopy with transbronchial biopsies after lung transplantation were offered participation in the study.

Patients not meeting eligibility criteria were not included. Informed consent was obtained immediately prior to the procedure. Patients were randomized in a double-blind, placebo-controlled fashion.

Unit of analysis: Procedures

Participant milestones

Participant milestones
Measure	Prophylactic Topical Epinephrine Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. Topical epinephrine: Prophylactic topical epinephrine	Placebo Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. Placebos: Topical placebo (normal saline)
Overall Study STARTED	33 46	33 54
Overall Study COMPLETED	33 46	33 54
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prophylactic Topical Epinephrine n=46 Procedures Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. Topical epinephrine: Prophylactic topical epinephrine	Placebo n=54 Procedures Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. Placebos: Topical placebo (normal saline)	Total n=100 Procedures Total of all reporting groups
Age, Continuous	62 years n=5 Participants	64 years n=7 Participants	63.5 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	21 Participants n=7 Participants	43 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · African American	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Latino	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Race / Ethnicity · Caucasian	22 Participants n=5 Participants	17 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure.

Intra-procedural hemorrhage will be graded by the performing bronchoscopist according to the following scale: 1. No hemorrhage. 2. Mild hemorrhage - Any bleeding originating from the biopsy target airway requiring wedging of the bronchoscope or "in and out" motion in order to achieve hemostasis. 3. Moderate hemorrhage - Any bleeding originating from the biopsy target airway requiring in addition to maneuvering the bronchoscope application of iced saline or topical epinephrine or placing the patient with the bleeding lung in the dependent position. 4. Severe hemorrhage - Any bleeding originating from the biopsy target airway requiring, in addition to the above-mentioned maneuvers, early termination of the procedure or necessitating application of balloon tamponade, endotracheal intubation, application of a bronchial blocker, or use of other invasive measures to achieve hemostasis, such as bronchial artery embolization or surgical intervention.

Outcome measures

Outcome measures
Measure	Prophylactic Topical Epinephrine n=46 Procedures Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. Topical epinephrine: Prophylactic topical epinephrine	Placebo n=54 Procedures Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. Placebos: Topical placebo (normal saline)
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist Severe or very severe hemorrhage	4 Procedures	13 Procedures
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist Moderate, severe, or very severe hemorrhage	11 Procedures	24 Procedures
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist Unblinded administration of epinephrine for bleeding	8 Procedures	20 Procedures
Intra-procedural Hemorrhage Grading by the Performing Bronchoscopist Early termination of the procedure due to bleeding	4 Procedures	13 Procedures

Adverse Events

Prophylactic Topical Epinephrine

Serious events: 4 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 4 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Prophylactic Topical Epinephrine n=33 participants at risk Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. Topical epinephrine: Prophylactic topical epinephrine	Placebo n=33 participants at risk Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. Placebos: Topical placebo (normal saline)
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.1% 2/33 • Number of events 2 • 48 hours	3.0% 1/33 • Number of events 1 • 48 hours
Respiratory, thoracic and mediastinal disorders Hypoxemic respiratory failure	6.1% 2/33 • Number of events 2 • 48 hours	9.1% 3/33 • Number of events 3 • 48 hours

Other adverse events

Other adverse events
Measure	Prophylactic Topical Epinephrine n=33 participants at risk Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical epinephrine in a blinded manner prior to performance of transbronchial lung biopsy. Topical epinephrine: Prophylactic topical epinephrine	Placebo n=33 participants at risk Study participants who meet inclusion and exclusion criteria and allocated to this arm will be randomized to receive prophylactic endobronchial topical placebo in the form of normal saline in a blinded manner prior to performance of transbronchial lung biopsy. Placebos: Topical placebo (normal saline)
Cardiac disorders Drop in BP >20 from baseline	48.5% 16/33 • Number of events 16 • 48 hours	54.5% 18/33 • Number of events 18 • 48 hours

Additional Information

Robert M. Reed

University of Maryland

Phone: 4103288141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place