A Pilot Study Comparing Anti-Inflammatory Effects Of Tranexamic Acid Versus Epsilon Aminocaproic Acid In Pediatric Congenital Heart Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Inflammatory Markers/Cytokines
研究概览
简要总结
The purpose of this study is to compare anti-inflammatory effects of two anti-fibrinolytic drugs (Tranexamic acid versus Epsilon-aminocaproic acid) in pediatric patients undergoing pediatric cardiac surgery.
详细描述
Bleeding under cardiopulmonary bypass (CPB) is one of the most common complications in patients undergoing pediatric cardiac surgery. The inflammatory response produced during and after CPB is a factor that adds significantly to the morbidity after cardiac surgery. A number of factors have been shown to be involved inducing the inflammatory response. These include complement system activation and activation of inflammatory cytokines, especially Interleukin (IL)-1, IL-6, IL-8 and Tumor necrosis factor (TNF) alpha.
Tranexamic Acid (TXA) and Epsilon-Aminocaproic Acid (EACA) are lysine analogues frequently used as anti-fibrinolytic agents in patients undergoing CPB. Many authors have highlighted the role of TXA in reducing blood loss and blood transfusion during and after CPB. Role of EACA and aprotinin in decreasing pro-inflammatory response during and after CPB has been well documented in adult literature. Patients undergoing redo sternotomy have higher inflammatory response as compared to patients undergoing first cardiac surgery. It has also been shown that the TXA can reduce the inflammatory response after CPB by acting directly or indirectly on the inflammatory cytokines.
There are no studies directly comparing the anti-inflammatory properties of EACA and TXA in the pediatric population undergoing CPB. In our institution, EACA is used as the standard of practice to reduce the blood loss during pediatric cardiac surgeries, but the investigators have now started using TXA more recently.
The aim of this study is to compare the anti-inflammatory and anti-fibrinolytic properties of these two anti-fibrinolytic agents in pediatric patients undergoing CPB for cardiac surgery.
Hypothesis: Tranexamic acid (TXA) has better anti-inflammatory profile as compared to €-Amino Caproic Acid (EACA) which may help in reducing blood loss, renal injury, hepatic injury and blood transfusion during and after CPB
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing pediatric cardiac surgery, with redo sternotomy needing cardiopulmonary bypass
排除标准
- •Patients undergoing Fontan or Glenn procedures
- •Allergy to EACA or TXA
- •Baseline coagulation profile abnormality * (The coagulation profile will be used as an exclusion criteria, if results available. Occasionally the results of coagulation profile may be unavailable prior to surgery due to a clotted sample. For such patients, as per the current clinical practice, we would not be redrawing the lab solely for a research purpose)
- •Prothrombin time (PT) >50% of High Normal value
- •Partial Thromboplastin Time (PTT) > 50% of High Normal value
- •Platelets < 50,000/mm3
- •International normalized ratio (INR) >2
- •Acute or chronic renal failure (creatinine > 2x high normal for age)
- •Chronic hepatopathy (any transaminase > 2x high normal for age)
- •Use of immunosuppressant drugs (within last 1 month)
- •History of seizures (currently on antiepileptic drugs for epilepsy or history of seizure within last 6 months)
研究组 & 干预措施
Tranexamic Acid Arm
TXA arm will include 10 subjects who will receive TXA for duration of surgery.
干预措施: Tranexamic acid (Drug)
Epsilon Aminocaproic Acid Arm
EACA arm will include 10 subjects who will receive EACA for the duration of surgery.
干预措施: Epsilon Aminocaproic Acid (Drug)
结局指标
主要结局
Inflammatory Markers/Cytokines
时间窗: 24 hours post-surgery
Consented patients had research-related blood draws (0.3 ml) at three time points: pre-CPB, post-CBP following protamine administration and 24 hours post-CPB. Average of the values run in duplicate was used for calculations. For samples with values reported as out of range (due to level being below detection), the lowest detectable value was assigned for analysis.
次要结局
- Chest Tube Output(48 hours post-surgery)
- Blood Replacement Volume(48 hours post-surgery)
- Platelet Levels(Immediately post-surgery and 24 hours post-surgery)
- Liver Enzymes(Immediately post-surgery and 24 hours post-surgery)
- Hemoglobin(Immediately post-surgery and 24 hours post-surgery)
- Creatinine(Immediately post-surgery and 24 hours post-surgery)
- Length of Stay(2 months)