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临床试验/NCT05925426
NCT05925426已完成不适用

Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2022年7月1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
103
试验地点
1
主要终点
Elongation Index (Deformability)

研究概览

简要总结

The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back.
  • This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery.
  • Only patients with the capacity to consent will be included.

排除标准

  • Patients indicated for spinal surgery without the use of Cell Saver.

结局指标

主要结局

Elongation Index (Deformability)

时间窗: Day 1 (Day of Surgery)

Ektacytometry will be employed to measure elongation index of salvaged RBCs.

Lactate Dehydrogenase (LDH) Levels

时间窗: Day 1 (Day of Surgery)

LDH assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo.

Hemoglobin Levels

时间窗: Day 1 (Day of Surgery)

Hemoglobin assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo.

Critical Shear Stress (Aggregation)

时间窗: Day 1 (Day of Surgery)

Ektacytometry will be employed to measure critical shear stress of salvaged RBCs.

次要结局

  • Use of Cell Saver(Day 1 (Day of Surgery))
  • Units of allogeneic blood transfused intraoperatively(Day 1 (Day of Surgery))
  • Standardized Quantified Blood Loss (mL)(Day 1 (Day of Surgery))
  • Units of autologous blood transfused intraoperatively(Day 1 (Day of Surgery))
  • Duration of pressor use(1 Day (Day of Surgery))
  • Volume (mL) collected via Cell Saver(Day 1 (Day of Surgery))
  • Units of allogeneic blood transfused postoperatively(Day 1 (Day of Surgery))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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