NCT02724605已完成2 期
Is Intraoperative Red Blood Cells Transfusion With Different Storage Duration Has Effect on Some Biochemical Parameters in Pediatric Trauma Patients Need Intraoperative Transfusion?
Abdelrady S Ibrahim, MD1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Serum potassium level
研究概览
简要总结
The aim of the study is to detect if the storage duration of red blood cells has impact on some biochemical parameters after intra operative transfusion in pediatric trauma patient
详细描述
- A pretransfusion draw of a few drops of patient venous blood, send for analysis by i-STAT Portable Clinical Analyser. Samples are processed immediately and provide laboratory quality results in 2 minutes using the CHEM 8+ i-STAT cartridge for measurement of:
- Potassium (K)
- Ionized Calcium (iCa)
- Glucose (Glu)
- Urea Nitrogen (BUN)/Urea
- Hemoglobin (Hb) and Hematocrit (Hct).
- Concurrently, a few drops of blood will be taken from the unit to be transfused will be analysed by i-STAT Portable Clinical Analyser for measurement of previous biochemical parameters.
- The details of the unit, such as draw date, volume of transfusion, and date of transfusion, will be recorded. The RBC unit will be delivered to the operative room from the blood bank in an insulated box.
- The transfusion is then given as clinically indicated at a rate of 50 to 150 mL/h based on the clinician's orders, the patient's weight, and the patient's clinical situation.
- Volumes will be transfused to children according to the following top-up transfusion equation: desired Hemoglobin (Hb) (g/dl) - actual Hemoglobin (Hb) (g/dl) x weight (kg) x 3. (usually 10-20 ml/kg).
- A second patient blood sample will be drawn one hour after the transfusion and will be analyzed by i-STAT Portable Clinical Analyser.
- Patient information will be recorded for age, weight, sex, and primary diagnosis.
- Demographic and clinical variables will be collected, to include type and quantity of all blood products and fluids received and medications administered. All surgical procedures will be documented.
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
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •.ASA I-II physical status patients.
- •Genders Eligible for Study : both .
- •Age: 2_10 years
- •All non-crush trauma pediatric patients need intraoperative RBC transfusion.
- •RBCs transfusion Volume within 10-20ml/kg.
排除标准
- •Patients with renal failure (serum creatinine 1.5 mg/dL)
- •Hepatic insufficiency.
- •Furosemide diuresis.
- •Succinylcholine for rapid sequence induction.
- •Electrolytes disorders.
研究组 & 干预措施
Group A
Other
Red blood cells unit age 14 days or less
干预措施: Red blood cells unit age 14 days or less (Biological)
Group B
Other
Red blood cells unit age more than 14 days
干预措施: Red blood cells unit age more than 14 days (Biological)
结局指标
主要结局
Serum potassium level
时间窗: One hour after red blood cells transfusion
Mmol/l
次要结局
- Serum ionised calcium(One hour after red blood cells transfusion)
- Serum glucose level(One hour after red blood cells transfusion)
- Blood Urea Nitrogen(One hour after red blood cells transfusion)
- Hemoglobin level(One hour after red blood cells transfusion)
研究者
Abdelrady S Ibrahim, MD
Assistant professor of Anesthesia and Intensive care
Assiut University
研究点 (1)
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