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Clinical Trials/NCT02607150
NCT02607150
Completed
Not Applicable

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

Nationwide Children's Hospital1 site in 1 country50 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Idiopathic Scoliosis
Sponsor
Nationwide Children's Hospital
Enrollment
50
Locations
1
Primary Endpoint
Cerebral Oxygenation Changes
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
March 2016
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph D. Tobias

Chairman, Department of Anesthesiology and Pain Medicine

Nationwide Children's Hospital

Eligibility Criteria

Inclusion Criteria

  • Any patient undergoing spinal surgery

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Cerebral Oxygenation Changes

Time Frame: Intraoperative measure

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

Secondary Outcomes

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

Study Sites (1)

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