TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Number of patients enrolled per month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
To maintain blinding, all personnel except the investigational pharmacist and/or statistician will be unaware of the administered drug.
The randomization schedule will be pre-determined by a central randomization process and prepared as "use next boxes" to streamline the process at enrollment
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received a tonsillectomy
- •Presents to the ED with secondary* post-tonsillectomy hemorrhage
- •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).
排除标准
- •Known and documented bleeding or clotting disorder.
- •Known pregnancy.
- •Patients with known hypersensitivity or allergic response to tranexamic acid.
- •Parents or guardians who cannot communicate in English or Spanish.
- •Intubation prior to enrollment.
- •Previously enrolled patients.
研究组 & 干预措施
Nebulized Tranexamic Acid
Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
干预措施: Tranexamic Acid Injectable Product (Drug)
Nebulized Saline
Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
干预措施: Normal Saline (Other)
结局指标
主要结局
Number of patients enrolled per month
时间窗: Baseline to 18 months (or duration of study approximately 18 months)
Assess target enrollment of patients per site per month.
Number of nebulizations per patient
时间窗: 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
Indirect local concentration of nebulized TXA
时间窗: Immediately post nebulizer treatment (within 60 minutes) and then within 8 hours.
Limited data on nebulized TXA systematic absorption. Topical PK studies of TXA document a significant reduction in systematic levels but the same hemostasis effect. Collection of two blood samples from each participant. This will verify a pulmonary physiological-based PK model (PBPK) (i.e., nasal cavity, pharynx, and lung) that indirectly predicts the oropharyngeal and systematic concentration of nebulized TXA.
Systemic Concentration of nebulized TXA
时间窗: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.
Pharmacokinetics samples will be collected after completion of the last nebulized treatment received within sixty minutes. A second time point should then be collected after sixty minutes up to eight hours from last nebulization, separated from the previous time point by at least sixty to ninety minutes. The serum TXA levels will be used to verify a TXA Physiological-based Pharmacokinetic model and determine the population variability. This PBPK model is built by our research pharmacist based on extensive research already completed on TXA distribution and metabolism. Once the model is built, the investigators only need a one to two samples to determine if the model accurately reflects collect samples. The investigators will develop a base model to determine a best-fit compartmental model, distribution, and elimination kinetics. The investigators will also use stochastic models to evaluate between-subject variability in PK parameters.
次要结局
- Number of return visits to the OR(Baseline to 18 months (or duration of study approximately 18 months))
- Estimated blood loss(Baseline to 7 days)
- Number of recurrences of PTH(Baseline to 18 months (or duration of study approximately 18 months))
- Number of blood transfusions required(Baseline to 18 months (or duration of study approximately 18 months))
研究者
Andrew D. Meyer
Associate Professor
The University of Texas Health Science Center at San Antonio