NCT03286465已完成不适用
Pilot, Randomized Trial of the Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell Transfusions
The University of Texas Health Science Center, Houston2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年11月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
研究概览
简要总结
This study will evaluate the hypothesis that the use of pediatric size phlebotomy tubes reduces red blood cell (RBC) transfusions in adult intensive care unit (ICU) patients compared with the use of adult size tubes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •New admission to the medical or transplant ICU at Memorial Hermann Hospital in Houston
- •ICU admission hemoglobin level of at least 7 g/dL. The ICU admission hemoglobin will be the most recent hemoglobin value available at the time of screening for inclusion in the study.
- •Randomization is expected within 12 hour of admission to the ICU
排除标准
- •Clinical bleeding. Defined as menstrual bleeding, bleeding leading to a change in the frequency of hemoglobin monitoring or to an order for a medication, transfusion, procedure, or consultation intended to prevent or treat bleeding.
- •Known hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia)
- •Bone marrow disorder (e.g. aplastic anemia, marrow infiltration disorder, chemotherapy within the last 8 weeks)
- •Jehovah's Witnesses
- •Patient is comfort care measures only
- •Refractory shock: mean arterial blood pressure below 60 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.04 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min
- •Severe acidosis: potential of hydrogen (pH) below 7 in more than one arterial blood gas within 24 hours of ICU admission in the absence of diabetic ketoacidosis Surgical admission diagnosis
- •Pregnancy
- •Current prisoner
结局指标
主要结局
Number of Participants Who Had Hemoglobin Less Than 7 g/dL or Red Blood Cell (RBC) Transfusion Order
时间窗: from time of admission to intensive care unit (ICU) to 30 days after admission to ICU
次要结局
- Number of Participants With at Least One Inadequate Blood Sample for Laboratory Analysis(completion of study (up to 30 days after ICU admission))
- Rate of Change in Hemoglobin (g/dL/Day) While in the Intensive Care Unit (ICU)(from time of randomization to completion of study (up to 30 days after ICU admission))
- Total Phlebotomy Volume(completion of study (up to 30 days after ICU admission))
- Number of Participants Who Received a Red Blood Cell (RBC) Transfusion While in the ICU(completion of study (up to 30 days after ICU admission))
- ICU Mortality(completion of study (up to 30 days after ICU admission))
研究者
Javier Barreda Garcia
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (2)
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