Clinical Trial: Prophylactic Topical Epinephrine to Reduce Bleeding in Transbronchial Lung Biopsies
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Prophylactic Topical Epinephrine to Reduce Transbronchial Lung Biopsy-related Hemorrhage in Lung Transplant Recipients: a Prospective Double-blind Placebo-controlled Trial (PROPHylactic Epinephrine in
Brief Summary: Bleeding poses potential for significant complication after transbronchial lung biopsies. The investigators hypothesize that prophylactic intrabronchial instillation of topical epinephrine will reduce the likelihood of bleeding. The investigators plan a double-blind, placebo controlled trial to evaluate this hypothesis.
Detailed Summary:
The role of prophylactic topical epinephrine in improving hemostasis and prevention of clinically-significant pulmonary hemorrhage has never been studied formally in the past, despite its common use by pulmonologists performing bronchoscopic TBLB. Lung transplant recipients undergo multiple bronchoscopies and TBLBs for surveillance and evaluation of ACR as well as lung infection, especially during the first year post-transplantation. This population may have a predilection to TBLB-related bleeding and may benefit from measures to reduce the frequency and magnitude of this relatively common complication.
In the PROPHET trial, the investigators intend to assess the degree of biopsy-related bleeding, measures taken to control bleeding, and potential effects of bleeding on completion of the intended procedure in 50 bronchoscopy procedures performed on single and double lung transplant recipients, randomized to prophylactic topical epinephrine versus placebo (normal saline). The study participant, physician performing the TBLB, and independent observer reviewing the procedure recording will all be blinded to the randomization. Further use of measures to control bleeding that occurs during the procedure as well as the decision to complete the procedure as planned or to abort it prematurely will be left to the discretion of the performer. In this way, the investigators aim to elucidate a potential role of topical epinephrine in the prevention of TBLB-related airway bleeding in lung transplant recipients and assess whether the dose and volume of instillation used in the investigators' institution comprises an effective means to prevent hemorrhagic complications of TBLB.
HYPOTHESIS
The investigators hypothesize that prophylactic instillation of topical epinephrine prior to performan
Sponsor: University of Maryland
Current Primary Outcome: Major hemorrhage as defined by two independent reviewers. [ Time Frame: Primary outcome is defined as hemorrhage occurring up to 30 minutes after withdrawal of the bronchoscope and deemed related to transbronchial lung biopsy. ]
The primary efficacy outcome of the PROPHET Study is the prevalence of major hemorrhage during bronchoscopy as defined by two independent reviewers who will review the procedure video while blinded to the individual patient information, study drug assignment, and any procedure related data not recorded on video. Hemorrhage will be graded according to the following grading system:
- No hemorrhage.
- Minor hemorrhage - Endobronchial hemorrhage resulting in segmental or more distal bronchus blood spillage.
- Intermediate hemorrhage - Endobronchial hemorrhage resulting in lobar bronchus blood spillage.
- Major hemorrhage - Endobronchial hemorrhage resulting in mainstem bronchus, more proximal blood spillage, or spillage into the uninvolved lung.
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Occurrence of no, minor, or intermediate bleeding as defined by the independent reviewer. [ Time Frame: This outcome is defined as hemorrhage occurring during the bronchoscopic procedure and deemed related to transbronchial lung biopsy and up to 30 minutes following withdrawal of the bronchoscope. ]Prevalence of no-, minor, or intermediate hemorrhage during bronchoscopy as defined by two independent reviewers who will review the procedure video while blinded to the individual patient information, study drug assignment, and any procedure related data not recorded on video.
- Intra-procedural hemorrhage grading by the performing bronchoscopist [ Time Frame: 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:
- No hemorrhage.
- 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.
- 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.
- 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.
- Number of forceps passes performed [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Number of biopsy forceps passes performed during bronchoscopy.
- Number of adequate tissue samples obtained [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Number of adequate tissue samples obtained during bronchoscopy as assessed by the performing bronchoscopist.
- Early termination of the procedure [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Early termination of the procedure due to bleeding complication, defined as non-achievement of the target number of tissue samples as designated by the performing bronchoscopist prior to the procedure related to hemorrhage.
- Duration of the procedure [ Time Frame: Duration of the procedure from first bronchoscope insertion to last bronchoscope withdrawal. ]Duration of the procedure from first bronchoscope insertion to last bronchoscope withdrawal.
- Total volume of iced saline used [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Total volume (mL) of iced saline used during the procedure.
- Total dose of unblended topical epinephrine used [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Total dose (mg) of unblended topical epinephrine used during the procedure.
- Any use of hemostatic measures [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Any use of hemostatic procedures including balloon tamponade, endobronchial blocker, bronchial artery embolization, emergency surgery.
- Any use of devices or procedures with intention of securing the airway [ Time Frame: This outcome will be analyzed at the time of procedure performance. ]Any use of devices or procedures with intention of securing the airway including oral airway, nasal airway, laryngeal mask, endotracheal intubation, emergency cricothyroidotomy, and emergency tracheostomy.
- Unplanned admission to the hospital. [ Time Frame: This outcome will be analyzed at the time of procedure performance and up to 48 hours following the procedure. ]Unplanned admission to the hospital.
- Pathologic diagnosis achieved. [ Time Frame: Up to 30 days post-procedure. ]Biopsy resulting in acquisition of a specimen which allows a viable pathologic diagnosis.
- All-cause mortality [ Time Frame: Within 3 hours on instillation of study drug. ]All-cause mortality
- Acute cardiovascular event [ Time Frame: Within 30 minutes of instillation of the study drug. ]Same as current
Information By: University of Maryland
Dates:
Date Received: April 17, 2017
Date Started: May 1, 2017
Date Completion: May 1, 2020
Last Updated: April 21, 2017
Last Verified: April 2017
