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

Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02607150
• Other study ID #: IRB14-00889
• Status: Completed
• Phase: N/A
• First received: November 16, 2015
• Last updated: April 6, 2016
• Start date: December 2014
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any patient undergoing spinal surgery

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Transfusion Reaction

Intervention

Other:
• Cerebral Oxygenation Changes
Monitor cerebral oxygenation changes in patients receiving blood transfusions who are undergoing spinal fusion surgery.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral Oxygenation Changes	To evaluate changes in tissue and cerebral oxygenation during the administration of autologous or allogeneic blood during spinal surgery.	Intraoperative measure	No
Secondary	Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions	To determine if there are differences in the changes in tissue and cerebral oxygenation with autologous compared to allogeneic blood.	Intraoperative measure	No