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TEAPOT Study Multisite (TEAPOT)

2026年7月15日 更新者：Andrew D. Meyer、The University of Texas Health Science Center at San Antonio

TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study

After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

The study intervention involves administering nebulized tranexamic acid (TXA) to pediatric patients with traumatic hemorrhage (PTH). The intervention consists of three consecutive doses of nebulized TXA.

The dosage of nebulized TXA is adjusted based on the child's weight. For children weighing more than 25 kg, each dose is 500 mg. For children weighing less than 25 kg, each dose is 250 mg.

Frequency: The three doses of nebulized TXA are administered consecutively over the course of approximately an hour. Administration Method: Nebulized TXA is delivered through a nebulizer device. A nebulizer converts the liquid medication into a fine mist or aerosol, which is then inhaled by the patient. This method allows the medication to be delivered directly to the respiratory tract, where it can exert its effect on the bleeding site. Delivery Setting: The intervention may take place in a clinical setting, such as a hospital or outpatient clinic, where nebulizer devices and medical supervision are readily available. Each patient receives three nebulized independent doses of TXA in succession. The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications.

研究类型

介入性

注册 (估计的)

30

阶段

  • 第一阶段早期

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • California
      • Davis、California、美国、95819
        • 招聘中
        • University of California at Davis Medical Center
        • 接触：
    • Rhode Island
      • Providence、Rhode Island、美国、02903
        • 尚未招聘
        • Hasbro Childrens' Hospital
        • 接触：
    • Texas
      • San Antonio、Texas、美国、78229
        • 尚未招聘
        • University Hospital
        • 接触：
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Received a tonsillectomy
  2. Presents to the ED with secondary* post-tonsillectomy hemorrhage
  3. Children between age of 2 to 17 years of age (i.e., before their 18th birthday) *Secondary post-tonsillectomy hemorrhage is defined as greater than 24 hours from their primary tonsillectomy operation (arrival in recovery/PACU).

Exclusion Criteria:

  1. Known and documented bleeding or clotting disorder.
  2. Known pregnancy.
  3. Patients with known hypersensitivity or allergic response to tranexamic acid.
  4. Parents or guardians who cannot communicate in English or Spanish.
  5. Intubation prior to enrollment.
  6. Previously enrolled patients.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：雾化氨甲环酸
如果受试者在手术后因出血返回急诊室，将在扁桃体切除术后给予雾化 TXA
药品：氨甲环酸注射液产品
参与者将接受三剂 TXA 500 mg（5 mL TXA 100mg/ml），使用 PARI LC D 一次性雾化器或同等雾化器，使用 8 升/分钟或更高的气流，在 10-15 分钟内雾化。
其他名称：
  • TXA 100毫克/毫升
安慰剂比较：雾化盐水
如果受试者在手术后因出血返回急诊室，将在扁桃体切除术后给予雾化盐水
其他：生理盐水
参与者将接受三剂 5 毫升剂量的安慰剂（生理盐水），使用 PARI LC D 一次性雾化器或同等雾化器使用 8 升/分钟或更高的气流在 10-15 分钟内雾化。
其他名称：
  • 0.9% 盐水溶液

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
雾化 TXA 的间接局部浓度
大体时间：雾化器治疗后立即（60 分钟内），然后在 8 小时内。
雾化 TXA 系统吸收的数据有限。 TXA 的局部 PK 研究表明，系统水平显着降低，但止血效果相同。 从每个参与者身上采集两份血液样本。 这将验证基于肺部生理学的 PK 模型 (PBPK)（即鼻腔、咽部和肺），该模型间接预测雾化 TXA 的口咽和系统浓度。
雾化器治疗后立即（60 分钟内），然后在 8 小时内。
雾化 TXA 的全身浓度
大体时间：雾化器治疗后立即（60 分钟内）和最多 8 小时。
最后一次雾化治疗完成后六十分钟内将收集药代动力学样品。 然后应在上次雾化后 60 分钟至 8 小时后收集第二个时间点，与前一个时间点至少相隔 60 至 90 分钟。 血清 TXA 水平将用于验证基于 TXA 生理学的药代动力学模型并确定群体变异性。 该 PBPK 模型是由我们的研究药剂师根据已完成的 TXA 分布和代谢的广泛研究建立的。 模型建立后，研究人员只需要一到两个样本即可确定模型是否准确反映了收集的样本。 研究人员将开发一个基本模型来确定最适合的区室模型、分布和消除动力学。 研究人员还将使用随机模型来评估 PK 参数的受试者间变异性。
雾化器治疗后立即（60 分钟内）和最多 8 小时。
Number of patients enrolled per month
大体时间：Baseline to 18 months (or duration of study approximately 18 months)
Assess target enrollment of patients per site per month.
Baseline to 18 months (or duration of study approximately 18 months)
Number of nebulizations per patient
大体时间：Baseline to 18 months (or duration of study approximately 18 months)
Evaluate the ability to nebulize at least two doses of TXA to children with PTH
Baseline to 18 months (or duration of study approximately 18 months)

次要结果测量

结果测量
措施说明
大体时间
估计失血量
大体时间：基线至 7 天
确定每个参与者的估计失血量
基线至 7 天
Number of return visits to the OR
大体时间：Baseline to 18 months (or duration of study approximately 18 months)
The need for return to the Operating Room (OR) for surgical management of PTH) will be followed for up to seven days after randomization
Baseline to 18 months (or duration of study approximately 18 months)
Number of recurrences of PTH
大体时间：Baseline to 18 months (or duration of study approximately 18 months)
Number of participants in which there was a recurrence of post-tonsillectomy hemorrhage after the study drug was administered
Baseline to 18 months (or duration of study approximately 18 months)
Number of blood transfusions required
大体时间：Baseline to 18 months (or duration of study approximately 18 months)
Blood product transfusion volume will be measured at discharge or 24 hours (whichever comes first). This will include the volume of packed red blood cells, platelets, plasma, cryoprecipitate, or whole blood. Any mention of blood loss in electronic health records from emergency, anesthesiology, or surgeons' notes will be recorded.
Baseline to 18 months (or duration of study approximately 18 months)

其他结果措施

结果测量
措施说明
大体时间
Wong-Baker FACES Pain Rating Scale or FLACC (Face, Legs, Activity, Cry, Consolability) Score
大体时间：Day 7 after randomization (plus or minus one day)

Admission of this pain scale will be age dependent, but yields the same score for the patient selection of pain or the visual cues available for pain assessment by the study team.

Wong-Baker FACES Pain scale:

The participant rates their pain from 0=No hurt to 10=Hurts worst, with a higher score indicating greater pain.

FLACC Score:

Scores 5 items from 0-2 with a total possible score of 10. A higher score indicates more pain.
Day 7 after randomization (plus or minus one day)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Adults
大体时间：Day 7 after randomization (plus or minus one day)
The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.
Day 7 after randomization (plus or minus one day)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Children
大体时间：Day 7 after randomization(plus or minus one day)
The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.
Day 7 after randomization(plus or minus one day)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Texas Health Science Center at San Antonio

合作者

National Heart, Lung, and Blood Institute (NHLBI)

调查人员

  • 首席研究员：Andrew D Meyer, MD, MS、The University of Texas Health Science Center at San Antonio

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月14日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2028年9月30日

研究注册日期

首次提交

2026年4月27日

首先提交符合 QC 标准的

2026年4月27日

首次发布 (实际的)

2026年5月4日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月15日

最后验证

2026年1月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • IRB# 00191036
  • R34HL177446 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results in Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results in information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.

IPD 共享时间框架

Data from this study may be requested by other researchers 3 years after the completion of the primary endpoint by contacting Andrew D. Meyer, MD, MS or through the DCC public use dataset website.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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