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NCT03676023 · ClinicalTrials.gov registry record
Tranexamic Acid Per Inhalation for Treatment of Pulmonary Hemorrhage in Pediatric Patients
A clinical trial, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- 20
- Enrollment target
NCT03676023: Completed study, sponsored by Baylor College of Medicine.
NCT03676023 is a clinical trial that has completed, run by Baylor College of Medicine. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03676023 has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- 20 participants
- Enrollment target
Study Summary
Pulmonary hemorrhage can be severe and life-threatening. In children, etiologies of pulmonary hemorrhage include respiratory infection, foreign bodies, bronchiectasis, pulmonary vascular disorders, parenchymal lung disease, and post-surgical complications. Initial management of pulmonary hemorrhage includes stabilization of the patient, securing the airway, initiative high positive end-expiratory pressure to attempt to tamponade the source of hemorrhage and repletion with blood products. Following stabilization of the patient, investigation and further management of hemorrhage includes bronchoscopy, surgery, or catheterization. Sources of bleeding such as endobronchial lesions are often identified and managed with bronchoscopy and the instillation of vasoactive medications or cold water to induce vasospasm and/or balloon tamponade. Vascular bleeding can be surgically ligated or embolized via catheterization. Unidentifiable bleeding occurs with distal vascular injury and is limited to attempted catheter guided embolization of bleeding vessels if found, supportive treatment, and correction of a coagulopathy if present. As etiologies of pulmonary hemorrhage vary, outcomes and prognosis in pediatric pulmonary hemorrhage are difficult to determine, however, mortality still remains a risk. Tranexamic acid (TXA) is a lysine analog that blocks the conversion of plasminogen to plasmin and the interaction with fibrin, preventing blood clot breakdown, thereby reducing bleeding. The United States (US) Food and Drug Administration approved the intravenous formulation of TXA for the treatment of bleeding patients with hemophilia in 1986 and the oral formulation for the use of severe menorrhagia in 2009. In 2011, The World Health Organization listed TXA as an essential medication based on its successful use in adult trauma-related hemorrhage. Studies show the successful off-label use of TXA in children for congenital heart surgery, orthopedic procedures, neurosurgical procedures,
Primary Outcome
resolution of PH
Interventions
- DRUG Tranexamic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2020-05-01 |
What the finished NCT03676023 record still lists
NCT03676023 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Tranexamic Acid is the first listed.
NCT03676023 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03676023 about?
NCT03676023 is a clinical study titled "Tranexamic Acid Per Inhalation for Treatment of Pulmonary Hemorrhage in Pediatric Patients". Pulmonary hemorrhage can be severe and life-threatening. In children, etiologies of pulmonary hemorrhage include respiratory infection, foreign bodies, bronchiectasis, pulmonary vascular disorders, parenchymal lung disease, and post-surgical complications. Initial management of pulmonary hemorrhage ...
What is the current status of trial NCT03676023?
This trial is currently completed. The enrollment target is 20 participants. The study started on 2018-03-01. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT03676023?
The interventions under investigation include: Tranexamic Acid (DRUG).
Who is sponsoring clinical trial NCT03676023?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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