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Completed

NCT Number: NCT02607150

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

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.

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Key information

Conditions

Idiopathic Scoliosis Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Transfusion Reaction

Sex eligibility

All sexes

Study type

Observational

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient undergoing spinal surgery

Exclusion criteria

  • None

Treatment and study plan

Cerebral Oxygenation Changes

Other

Monitor cerebral oxygenation changes in patients receiving blood transfusions who are undergoing spinal fusion surgery.

Primary outcomes

  1. 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

  1. Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions

    Time frame: Intraoperative measure

    To determine if there are differences in the changes in tissue and cerebral oxygenation with autologous compared to allogeneic blood.

Sponsors and collaborators

Lead sponsor

Nationwide Children's Hospital

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2015
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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