Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Complete primary data collection
研究概览
简要总结
STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for laboratory testing in reducing anemia and transfusion in intensive care unit patients without significant adverse consequences. This is a simple, cost-neutral intervention that could improve the quality of patient care and reduce the harms of frequent laboratory testing.
详细描述
The STRATUS Pilot Study is a prospective observational study (before-after design) to assess the feasibility of implementing a full-scale randomized trial powered for clinical outcomes (RBC transfusion, incidence and severity of anemia). Identification of barriers and facilitators of implementation will enhance the conduct of the full-scale trial and facilitate incorporation of the intervention into routine practice.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Complete primary data collection
时间窗: 14 weeks
Defined as at least 95% of patients with complete data collected
Sufficient volume for testing with small-volume tubes
时间窗: 6 week intervention period
Defined as \<3% of samples reported as inadequate volume for testing
Successful crossover from standard-volume to small-volume tubes
时间窗: 2 week washout period
Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period
Adherence to the correct tube size during the intervention period
时间窗: 6 week intervention period
Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area
Acceptability of the intervention by end-users
时间窗: 6 week intervention period
Acceptability qualitatively evaluated during structured focus group discussions
次要结局
- ICU and hospital length of stay(12 weeks)
- RBC units transfused(12 weeks)
- Change in hemoglobin(12 weeks)
- ICU and hospital mortality(12 weeks)
- Reduction in blood loss(12 weeks)