跳至主要内容
临床试验/NCT03676023
NCT03676023已完成不适用

Tranexamic Acid Per Inhalation for Treatment of Pulmonary Hemorrhage in Pediatric Patients

Baylor College of Medicine1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
resolution of pulmonary hemorrhage

研究概览

简要总结

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, trauma, immune thrombocytopenic purpura, epistaxis, hemorrhage complicating a procedure, bilateral lung transplantation, chemotherapy injections, and bone marrow biopsies among other diagnoses and procedures. Very little data on the use of TXA for pediatric pulmonary hemorrhage exists. Only two case reports show TXA controlling hemoptysis in children with cystic fibrosis-related hemoptysis. A systematic review concluded that the use of TXA for hemoptysis was associated with a significant reduction in length of bleeding. A recent randomized control trial showed the TXA decreased the severity of the hemoptysis and may be used as a bridge to other interventions.

The powerful anti-fibrinolytic properties and relatively low side-effect profile lend TXA to the off-label use in children to reduce bleeding in other diagnoses. There are not enough studies and data, however, to recommend the routine use of TXA in hemoptysis.

详细描述

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, trauma, immune thrombocytopenic purpura, epistaxis, hemorrhage complicating a procedure, bilateral lung transplantation, chemotherapy injections, and bone marrow biopsies among other diagnoses and procedures. Very little data on the use of TXA for pediatric pulmonary hemorrhage exists. Only two case reports show TXA controlling hemoptysis in children with cystic fibrosis-related hemoptysis. A systematic review concluded that the use of TXA for hemoptysis was associated with a significant reduction in length of bleeding. A recent randomized control trial showed the TXA decreased the severity of the hemoptysis and may be used as a bridge to other interventions.

The powerful anti-fibrinolytic properties and relatively low side-effect profile lend TXA to the off-label use in children to reduce bleeding in other diagnoses. There are not enough studies and data, however, to recommend the routine use of TXA in hemoptysis.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

  • search for "tranexamic acid" and compare those resulted patients manually to those within EPIC database. Patients identified with "pulmonary hemorrhage" or "hemoptysis" will be included for analysis.

排除标准

  • 未提供

研究组 & 干预措施

Pulmonary Hemorrhage

Patients treated for pulmonary hemorrhage with inhaled Transexamic Acid

干预措施: Tranexamic Acid (Drug)

结局指标

主要结局

resolution of pulmonary hemorrhage

时间窗: 5 days

resolution of PH

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marc Anders

Assistant Professor

Baylor College of Medicine

研究点 (1)

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