Prophylactic Endobronchial Tranexamic Acid to Reduce Bleeding in Transbronchial Cryobiopsy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Major Hemorrhage
研究概览
简要总结
Transbronchial cryobiopsies are common procedures used to obtain tissue samples from airways for diagnostic purposes. While these procedures are safe, there is a risk of bleeding from the biopsy site. We are conducting a research study to assess the safety and effectiveness of using tranexamic acid prior to undergoing a transbronchial cryobiopsy.
详细描述
Prophylactic tranexamic acid will be instilled via endobronchial route in all patients undergoing transbronchial cryobiopsy. The medication will be administered through the bronchoscope one minute prior to the cryobiopsy. 500 mg of TXA diluted in 10 ml of saline and the procedure would be carried out as usual.
The study will be a prospective, single-arm, non-randomized trial Location: Ascension Via Christi Saint Francis. Medication: Tranexamic acid 500 milligrams per 5 mL ampule (Baxter, NDC 43066-008-01) mixed with 10 mL normal saline.
Patients: A total of 100 patients will be enrolled in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Receiving a transbronchial cryobiopsy
排除标准
- •Age below 18
- •Pregnancy
- •Bleeding diathesis (INR >1.5 or known hematological problems)
- •Subarachnoid hemorrhage
- •Any active bleeding (any site)
- •Decompensated liver disease
- •Active intravascular clotting
- •Prior VTE
- •On oral contraceptive therapy
- •Platelet count less than 50,000
- •Use of antiplatelet medication other than low-dose aspirin within 5 days of procedure
- •Use of therapeutic anticoagulation within the last 24 hrs
- •Known severe pulmonary hypertension (pulmonary artery systolic pressure > 60 mmHg)
- •Chronic renal failure (estimated GFR below 30 mL/min)
- •Allergy or hypersensitivity to tranexamic acid or any of its ingredients
- •Prisoners
- •Comfort care planned or initiated within 72 hours of admission
研究组 & 干预措施
Control
Data collected retrospectively from patients undergoing the same procedure one year prior to the study initiation
Intervention
Prophylactic TXA arm
干预措施: Tranexamic acid (Drug)
结局指标
主要结局
Major Hemorrhage
时间窗: up to 2 hours post procedure
Ordinal scale of less severe to most severe 1\. No hemorrhage 2. Minor hemorrhage 3. Intermediate hemorrhage 4. Major hemorrhage
次要结局
- Acute cardiovascular side effects(up to 30 days post procedure)
- Early termination of the procedure due to bleeding(up to 2 hours post procedure)
- Rate of intermediate hemorrhage(up to 2 hours post procedure)
- Rate of minor hemorrhage(up to 2 hours post procedure)
- Graded use of other measures to control bleeding (not prophylactic)(up to 2 hours post procedure)
- Unplanned hospital admission for bleeding complications(2 hours post procedure uo to 30 days post procedure)
- All cause 28 day mortality(up to 28 days post procedure)
- Inadequate tissue sampling due to bleeding(up to 2 hours post procedure)
研究者
Youssef Yammine
Principal Investigator
Ascension Health