NCT05750654已完成不适用
Effectiveness of Small Phlebotomy Tubes in Reducing Blood Transfusions in Adult Medical Intensive Care Unit and Intermediate Care Unit Patients With Anemia: A Randomized Controlled Trial
The University of Texas Health Science Center, Houston1 个研究点 分布在 1 个国家目标入组 688 人开始时间: 2023年7月24日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of small phlebotomy tubes to reduce RBC transfusions in medical intensive care unit (ICU) and Intermediate care unit (IMU) patients with low hemoglobin compared with standard size tubes, to compare the intervention and the control groups in regards to: ICU length of stay (LOS), ICU mortality, hospital LOS, and hospital mortality and to assess the acceptability of small phlebotomy tubes in adult ICU and IMU patients.
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
- •Admission to the medical ICU or IMU.
- •Hemoglobin less than 10 g/dL.
排除标准
- •Clinical bleeding. Defined as any bleeding needing an intervention. An intervention could be an increase in the frequency of hemoglobin monitoring, a transfusion, a procedure, or a consultation intended to prevent or treat bleeding.
- •Hemolytic disorder (e.g. sickle cell disease, hereditary spherocytosis, autoimmune hemolytic anemia).
- •Bone marrow disorder (e.g. aplastic anemia, leukemia, 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 65 mmHg despite maximal doses of 3 vasopressors. Maximal dose of vasopressors are as follows: Norepinephrine 70 mcg/min; vasopressin 0.03 units/min; epinephrine 35 mcg/min; dopamine 20 mcg/kg/min; phenylephrine 350 mcg/min.
- •Severe acidosis: pH below 7 in more than one arterial blood gas in the past 24 hours, in the absence of diabetic ketoacidosis.
- •Surgical admission diagnosis.
- •Pregnancy.
- •Current prisoner
研究组 & 干预措施
Small Tube Group
Experimental
干预措施: Small Phlebotomy Tube Group (Device)
Standard Tube Group
Active Comparator
干预措施: Standard Phlebotomy Tube Group (Device)
结局指标
主要结局
Number of participants that receive a red blood cell (RBC) transfusion during hospitalization
时间窗: up to 30 days after randomization
次要结局
- Number of RBC units transfused during hospitalization(up to 30 days after randomization)
- Length of stay in ICU(completion of study (up to 90 days from enrollment))
- Number of participants that died while in ICU(completion of study (up to 90 days from enrollment))
- Length of stay in hospital(completion of study (up to 90 days from enrollment))
- Number of participants that died while in hospital(completion of study (up to 90 days from enrollment))
- Acceptability of small tubes as assessed by determining the number of patients that switch from small tubes to standard tubes(up to 30 days after randomization)
研究者
Javier Barreda Garcia
Assistant Professor
The University of Texas Health Science Center, Houston
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Small-Volume Tubes to Reduce Anemia and TransfusionBlood Loss AnemiaNCT03578419Population Health Research Institute27,411
已完成
不适用
Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)Blood Loss AnemiaNCT03284944Population Health Research Institute369
已完成
不适用
Use of Pediatric Size Phlebotomy Tubes in Adult Critically Ill Patients to Reduce Red Blood Cell TransfusionsAnemiaNCT03286465The University of Texas Health Science Center, Houston200
尚未招募
3 期
To study the effect of small size chest tube on pain in patients with chest injuryCTRI/2024/01/061124AIIMS, NEW DELHI
Unknown
不适用
A Clinical Trial To Evaluate Reduning Injection in the Treatment of Mild Type of Hand, Foot, and Mouth DiseaseHand, Foot and Mouth DiseaseNCT01175915Jiangsu Kanion Pharmaceutical Co., Ltd360