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

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ClinicalTrials.gov Identifier: NCT02607150
Recruitment Status : Completed
First Posted : November 17, 2015
Last Update Posted : April 7, 2016
Sponsor:
Information provided by (Responsible Party):
Joseph D. Tobias, Nationwide Children's Hospital

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.


Condition or disease Intervention/treatment
Idiopathic Scoliosis Transfusion Reaction Other: Cerebral Oxygenation Changes

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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood
Study Start Date : December 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Spinal surgery patients.
Criteria

Inclusion Criteria:

  • Any patient undergoing spinal surgery

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02607150


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
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Principal Investigator: Joseph D. Tobias, MD Nationwide Children's Hospital

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Responsible Party: Joseph D. Tobias, Chairman, Department of Anesthesiology and Pain Medicine, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT02607150     History of Changes
Other Study ID Numbers: IRB14-00889
First Posted: November 17, 2015    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Joseph D. Tobias, Nationwide Children's Hospital:
Spinal Fusion
Cerebral Oxygenation
Blood Transfusion
Additional relevant MeSH terms:
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Scoliosis
Transfusion Reaction
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Immune System Diseases