This trial is active, not recruiting.

Conditions idiopathic scoliosis, transfusion reaction
Treatment cerebral oxygenation changes
Sponsor Nationwide Children's Hospital
Start date December 2014
End date September 2016
Trial size 50 participants
Trial identifier NCT02607150, IRB14-00889


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Cerebral Oxygenation Changes
time frame: Intraoperative measure

Secondary Outcomes

Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions
time frame: Intraoperative measure

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Any patient undergoing spinal surgery Exclusion Criteria:

Additional Information

Official title Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood
Principal investigator Joseph D. Tobias, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Nationwide Children's Hospital.