NCT02607150

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 7, 2016

Status Verified

April 1, 2016

Enrollment Period

1.2 years

First QC Date

November 16, 2015

Last Update Submit

April 6, 2016

Conditions

Idiopathic ScoliosisTransfusion Reaction

Keywords

Spinal FusionCerebral OxygenationBlood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Cerebral Oxygenation Changes

    To evaluate changes in tissue and cerebral oxygenation during the administration of autologous or allogeneic blood during spinal surgery.

    Intraoperative measure

Secondary Outcomes (1)

  • Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions

    Intraoperative measure

Interventions

Cerebral Oxygenation ChangesOTHER

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Spinal surgery patients.

You may qualify if:

  • Any patient undergoing spinal surgery

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • Joseph D. Tobias, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Department of Anesthesiology and Pain Medicine

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 17, 2015

Study Start

December 1, 2014

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

April 7, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)