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临床试验/NCT02607150
NCT02607150已完成不适用

Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
Cerebral Oxygenation Changes

研究概览

简要总结

A prospective study designed to evaluate changes in tissue and cerebral oxygenation before and following administration of blood for patients undergoing spinal surgery.

Red blood transfusions (autologous and allogeneic) are indicated to improve oxygen delivery to the tissues and hence tissue oxygenation. Despite the presumed efficacy, there are limited data to demonstrate changes in tissue oxygenation with the administration of blood. Furthermore, the administration of both autologous blood from cell saver and allogeneic blood can be associated with both acute and long-term deleterious physiologic effects which may impact the perioperative course. As such, data are needed to clearly delineate the benefits of transfusion during the perioperative period.

详细描述

This prospective study will include patients presenting for spinal surgery. There will be no change in the anesthetic or perioperative care of these patients. Per our usual clinical routine, cell saver will be used intraoperatively to limit the need for allogeneic blood. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS). The device is applied non-invasively like pulse oximetry to a muscle bed (usually the deltoid) and the forehead to measure tissue oxygenation. These devices are used routinely in the operating room and the cardiothoracic intensive care unit. Although not used on every major orthopedic procedure, these devices are routinely used in various high risk clinical scenarios. As clinically indicated, cell saver blood (autologous) or allogeneic blood will be administered. During this time, tissue and cerebral oxygenation will be recorded every 5 minutes starting 10 minutes before the transfusion and continued for 30 minutes following the transfusion.

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 patient undergoing spinal surgery

排除标准

  • 未提供

结局指标

主要结局

Cerebral Oxygenation Changes

时间窗: Intraoperative measure

To evaluate changes in tissue and cerebral oxygenation during the administration of autologous or allogeneic blood during spinal surgery.

次要结局

  • Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions(Intraoperative measure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph D. Tobias

Chairman, Department of Anesthesiology and Pain Medicine

Nationwide Children's Hospital

研究点 (1)

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