Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02607150
Enrollment
50
Registered
2015-11-17
Start date
2014-12-31
Completion date
2016-03-31
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Scoliosis, Transfusion Reaction

Keywords

Spinal Fusion, Cerebral Oxygenation, Blood Transfusion

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.

Interventions

OTHERCerebral Oxygenation Changes

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

Sponsors

Nationwide Children's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Any patient undergoing spinal surgery

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Cerebral Oxygenation ChangesIntraoperative measureTo evaluate changes in tissue and cerebral oxygenation during the administration of autologous or allogeneic blood during spinal surgery.

Secondary

MeasureTime frameDescription
Oxygenation Changes in Autologous versus Allogeneic Blood TransfusionsIntraoperative measureTo determine if there are differences in the changes in tissue and cerebral oxygenation with autologous compared to allogeneic blood.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026