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临床试验/NCT06422273
NCT06422273Enrolling By Invitation3 期

Prophylactic Use of Tranexamic Acid Versus Saline to Prevent Bleeding During Transbronchial Biopsy in Lung Transplant Recipients- A Randomized Double-Blind Trial (Protest Trial)

Corewell Health West1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年4月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
Enrolling By Invitation
入组人数
94
试验地点
1
主要终点
Bleeding Risk

研究概览

简要总结

To determine if endobronchial (topical) tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients reduces bleeding risk.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Single or double lung transplant recipients
  • Patients >18 years old
  • Willingness and ability to sign an informed consent for study participation

排除标准

  • Platelet count (<50k/uL)
  • INR (>1.6)
  • Active bleeding
  • Decompensated liver disease
  • History of uremic bleeding or BUN >50
  • Severe pulmonary hypertension (mean PA pressure >40 mmHg on RHC or estimated PA systolic pressure >62 mmHg on TTE within one year of procedure)
  • Known bleeding disorder
  • Allergy to TXA
  • Prior history of severe TBBx-related airway bleeding requiring admission or advanced maneuvers for hemostasis (examples including intubation, bronchial artery embolization, surgical intervention)
  • Contraindications to topical TXA
  • Vulnerable populations
  • Adults of limited English proficiency/non-English speakers

研究组 & 干预措施

TXA

Experimental

Tranexamic acid used prophylactically prior to performing transbronchial biopsies in lung transplant recipients.

干预措施: Tranexamic Acid (Drug)

Saline

Placebo Comparator

Topical Saline (placebo) administered as endobronchial topical application.

干预措施: Saline (placebo) (Other)

结局指标

主要结局

Bleeding Risk

时间窗: up to 1 hour

Bleeding severity will be documented in the following categories: none, mild, moderate, severe and massive

次要结局

  • Greater yield in tissue samples(up to 1 hour)
  • Procedure time Reduction(up to 1 hour)

研究者

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

Sheila Krishnan

Principle Investigator

Corewell Health West

研究点 (1)

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