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To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.
Tranexamic acid (TXA) is an antifibrinolytic agent. It forms a reversible complex that displaces plasminogen from fibrin resulting in inhibition of fibrinolysis. It also inhibits proteolytic activity of plasmin. TXA is frequently used in clinical practice and can be administered via multiple delivery methods, including intravenous, nebulized, and topical. It has been shown to reduce blood loss in a variety of clinical settings without significant adverse effects. It has also been evaluated for prophylactic use with mixed results in reducing bleeding. In our current general pulmonary practice, topical TXA is used variably by pulmonologists during bronchoscopy for post-biopsy bleeding or pulmonary hemorrhage.
The purpose of this research study is to determine if prophylactic topical TXA can reduce bleeding risk in lung transplant patients who undergo transbronchial biopsies. A finding of reduced bleeding would be significant as it could improve clinical outcomes, allow for improved diagnostic yield of biopsy samples, and improve patient experience. It therefore has the potential to change clinical practice and standardize bronchoscopy procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TXA | Experimental | Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients. |
|
| Saline | Placebo Comparator | Topical Saline (placebo) administered as endobronchial topical application. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | Endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding Risk | Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive | up to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time Reduction | Procedure times will be recorded for both the tranexamic acid and the control saline group. | up to 1 hour |
| Greater yield in tissue samples | This will be measured by the number of pieces of tissue from the pathology report |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corewell Health West | Grand Rapids | Michigan | 49503 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2024 | May 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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The study design will be a single-center, randomized, double-blinded, placebo-controlled study. The control group will receive topical saline (placebo) and the experimental treatment group will receive topical Tranexamic acid (TXA active drug).
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The investigational pharmacist will be responsible for randomizing on the day of bronchoscopy to placebo or Tranexamic acid in a 1:1 fashion using REDCap software. The pharmacist will be the only individual aware of the randomization assignment. All other study personnel will be blinded to the randomization assignment.
| Saline (placebo) | Other | Topical Saline (placebo) administered as endobronchial topical application prior to performing transbronchial biopsies in lung transplant recipients. |
|
| up to 1 hour |
| D002712 |
| Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |