Spinal DeformityNCT05925426
Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery
An observational study of Spinal Deformity, run by NYU Langone Health at 1 site in United States.
Trial summary
The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Deformity
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Sep 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing any spine surgery that utilizes Cell Saver and has blood to be given back.
Who may be able to join
- Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back.
- This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery.
- Only patients with the capacity to consent will be included.
Who cannot join
- Patients indicated for spinal surgery without the use of Cell Saver.
Trial locations and contacts
1 site in 1 country.
About this study
The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?
- Conditions
- Spinal Deformity
- Keywords
- Red Blood Cells
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate Dehydrogenase (LDH) Levels
LDH assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo.
Measured: Day 1 (Day of Surgery)
Hemoglobin Levels
Hemoglobin assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo.
Measured: Day 1 (Day of Surgery)
Elongation Index (Deformability)
Ektacytometry will be employed to measure elongation index of salvaged RBCs.
Measured: Day 1 (Day of Surgery)
Critical Shear Stress (Aggregation)
Ektacytometry will be employed to measure critical shear stress of salvaged RBCs.
Measured: Day 1 (Day of Surgery)
Secondary outcomes (7)
Standardized Quantified Blood Loss (mL)
Measured: Day 1 (Day of Surgery)
Use of Cell Saver
This will be reported in a binary manner: 0 = yes, 1 = no
Measured: Day 1 (Day of Surgery)
Volume (mL) collected via Cell Saver
Measured: Day 1 (Day of Surgery)
Units of autologous blood transfused intraoperatively
Measured: Day 1 (Day of Surgery)
Units of allogeneic blood transfused intraoperatively
Measured: Day 1 (Day of Surgery)
Units of allogeneic blood transfused postoperatively
Measured: Day 1 (Day of Surgery)
Duration of pressor use
Measured: 1 Day (Day of Surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal DeformityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Darryl Lau, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925426
- Sponsor's protocol ID
- 22-00406
- Status last verified
- Mar 2025
- First submitted
- 22 Jun 2023
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurland DB, Alber D, Smith A, Ahmed S, Orringer D, Frempong-Boadu A, Lau D. What Are We Transfusing? Evaluating the Quality and Clinical Utility of Intraoperatively Salvaged Red Blood Cells in Spinal Deformity Surgery: A Nonrandomized Controlled Trial. Neurosurgery. 2024 Nov 1;95(5):976-985. doi: 10.1227/neu.0000000000003131. Epub 2024 Aug 1.
PubMed 39087785
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery
- ClinicalTrials.gov ID
- NCT05925426
- Acronym / sponsor ID
- 22-00406
- Conditions
- Spinal Deformity
- Keywords
- Red Blood Cells
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 29 Jun 2023 (actual)
- 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.
The actual quality of Red Blood Cells (RBCs) salvaged during spinal deformity surgery has never been rigorously evaluated. To characterize the usefulness of intraoperatively salvaged RBCs in spinal deformity surgery. The study team hopes to answer the following questions: 1) What is the quality of RBCs salvaged during spine surgery? 2) Does intraoperatively transfused RBC salvage impact clinical outcomes?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing any spine surgery that utilizes Cell Saver and has blood to be given back.
Key inclusion criteria (3 listed)
- Any/all patients undergoing spine surgery who utilizes Cell Saver and has blood to be given back.
- This will include pediatric patients 0-17 as well as adults of any age who have been indicated for surgery.
- Only patients with the capacity to consent will be included.
Key exclusion criteria (1 listed)
- Patients indicated for spinal surgery without the use of Cell Saver.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactate Dehydrogenase (LDH) Levels
Time frame: Day 1 (Day of Surgery)
LDH assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo.
Hemoglobin Levels
Time frame: Day 1 (Day of Surgery)
Hemoglobin assays will be performed following a standardized mechanical stress test will be used to determine whether salvaged red blood cells exhibit signs of fragility ex vivo.
Elongation Index (Deformability)
Time frame: Day 1 (Day of Surgery)
Ektacytometry will be employed to measure elongation index of salvaged RBCs.
Critical Shear Stress (Aggregation)
Time frame: Day 1 (Day of Surgery)
Ektacytometry will be employed to measure critical shear stress of salvaged RBCs.
7 secondary outcomes
Standardized Quantified Blood Loss (mL)
Time frame: Day 1 (Day of Surgery)
Use of Cell Saver
Time frame: Day 1 (Day of Surgery)
Volume (mL) collected via Cell Saver
Time frame: Day 1 (Day of Surgery)
Units of autologous blood transfused intraoperatively
Time frame: Day 1 (Day of Surgery)
Units of allogeneic blood transfused intraoperatively
Time frame: Day 1 (Day of Surgery)
Units of allogeneic blood transfused postoperatively
Time frame: Day 1 (Day of Surgery)
Duration of pressor use
Time frame: 1 Day (Day of Surgery)
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 11 Mar 2025.
- Derived from this study: PubMed 39087785Kurland DB, Alber D, Smith A, Ahmed S, Orringer D, Frempong-Boadu A, Lau D. What Are We Transfusing? Evaluating the Quality and Clinical Utility of Intraoperatively Salvaged Red Blood Cells in Spinal Deformity Surgery: A Nonrandomized Controlled Trial. Neurosurgery. 2024 Nov 1;95(5):976-985. doi: 10.1227/neu.0000000000003131. Epub 2024 Aug 1.
- Individual participant dataSharing planned: No
Related trials for Spinal Deformity
Recruiting
Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida
Myelomeningocele, Spina Bifida
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1
A Study of SGT-212 Gene Therapy in Friedreich's Ataxia
Friedreich's Ataxia (FA)
Active, not recruiting
Efficacy of Stabilometric Platform to Improve Standing Balance in Patients With Friedreich's Ataxia
Friedreich Ataxia
Recruiting
Electroencephalogram in Patients With Friedreich's Ataxia for the Study of the Structural and Functional Connectome.
Friedreich's Ataxia, Motor Disorders
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.
Darryl Lau, MD principal investigator
NYU Langone Health
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 Spinal Deformity, run by NYU Langone Health 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 3 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 11 Mar 2025. 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?
Lactate Dehydrogenase (LDH) Levels (time frame: Day 1 (Day of Surgery)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05925426, which also lists 1 linked publication.
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 11 Mar 2025.