Investigation of Anaphylactic Reaction in Cases Undergoing Cardiac By-Pass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Patients number with high tryptase level (> 25 µg/L ).
研究概览
简要总结
The investigators aim to assess tryptase test efficacy for measuring the allergic response to protamine during cardiac bypass surgery. Additionally, the investigators aim to establish a differential diagnosis on the basis of potential allergens or clinical causes.
详细描述
Venous blood samples from cardiac surgery cases will be obtained for tryptase measurement upon admission to the operating room (OR) and immediately prior to and 30 min after protamine infusion initiation. A rapid effect-response-based clinical assessment will be made using clinical and laboratory monitoring data for diagnosis and treatment decisions during protamine infusion, which may complicate the recovery from surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cardiac by-pass cases
排除标准
- •Insulin dependent diabetes
- •Drug allergy history
结局指标
主要结局
Patients number with high tryptase level (> 25 µg/L ).
时间窗: 30 min
Tryptase will be measured using the ImmunoCAP Tryptase kit (Phadia, Uppsala, Sweden), and the cutoff level for elevated tryptase is \>11.5 µg/L. A 25 µg/L cutoff value has been found to be highly suggestive of an İmmunoglobulin E (IgE) -mediated reaction.
次要结局
- Patients number with allergic reaction involving of 1 or more organ/systems (skin, respiratory, or cardiovascular system) following the study drug infusion. In this study, mainly the cardiovascular and skin symptoms will be focused on.(30 min)
研究者
MENEKSE OKSAR
Assistant Professor
Mustafa Kemal University