Idiopathic ScoliosisNCT02607150
Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood
An observational study of Idiopathic Scoliosis and Transfusion Reaction, run by Nationwide Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Scoliosis, Transfusion Reaction
- What is being tested?
- Cerebral Oxygenation Changes
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Spinal surgery patients.
Who may be able to join
- Any patient undergoing spinal surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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.
Read the 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.
- Conditions
- Idiopathic Scoliosis, Transfusion Reaction
- Being tested
- Cerebral Oxygenation Changes
- Keywords
- Spinal Fusion, Cerebral Oxygenation, Blood Transfusion
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral Oxygenation ChangesOther
Monitor cerebral oxygenation changes in patients receiving blood transfusions who are undergoing spinal fusion surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral Oxygenation Changes
To evaluate changes in tissue and cerebral oxygenation during the administration of autologous or allogeneic blood during spinal surgery.
Measured: Intraoperative measure
Secondary outcomes (1)
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.
Measured: Intraoperative measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
- Investigators
- Joseph D. Tobias, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607150
- Sponsor's protocol ID
- IRB14-00889
- Status last verified
- Apr 2016
- First submitted
- 16 Nov 2015
- Last updated
- 7 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation During the Administration of Cell Saver Blood and Allogeneic Blood
- ClinicalTrials.gov ID
- NCT02607150
- Acronym / sponsor ID
- IRB14-00889
- Conditions
- Idiopathic Scoliosis, Transfusion Reaction
- Keywords
- Spinal Fusion, Cerebral Oxygenation, Blood Transfusion
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Spinal surgery patients.
Key inclusion criteria (1 listed)
- Any patient undergoing spinal surgery
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral Oxygenation ChangesMonitor cerebral oxygenation changes in patients receiving blood transfusions who are undergoing spinal fusion surgery. | Other | – |
Primary outcome
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.
1 secondary outcome
Oxygenation Changes in Autologous versus Allogeneic Blood Transfusions
Time frame: Intraoperative measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph D. Tobias, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Scoliosis and Transfusion Reaction, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral Oxygenation Changes (time frame: Intraoperative measure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2016.