Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

June 28, 2023 updated by: NYU Langone Health
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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing any spine surgery that utilizes Cell Saver and has blood to be given back.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients indicated for spinal surgery without the use of Cell Saver.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 (Day of Surgery)
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.
Day 1 (Day of Surgery)
Elongation Index (Deformability)
Time Frame: Day 1 (Day of Surgery)
Ektacytometry will be employed to measure elongation index of salvaged RBCs.
Day 1 (Day of Surgery)
Critical Shear Stress (Aggregation)
Time Frame: Day 1 (Day of Surgery)
Ektacytometry will be employed to measure critical shear stress of salvaged RBCs.
Day 1 (Day of Surgery)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standardized Quantified Blood Loss (mL)
Time Frame: Day 1 (Day of Surgery)
Day 1 (Day of Surgery)
Use of Cell Saver
Time Frame: Day 1 (Day of Surgery)
This will be reported in a binary manner: 0 = yes, 1 = no
Day 1 (Day of Surgery)
Volume (mL) collected via Cell Saver
Time Frame: Day 1 (Day of Surgery)
Day 1 (Day of Surgery)
Units of autologous blood transfused intraoperatively
Time Frame: Day 1 (Day of Surgery)
Day 1 (Day of Surgery)
Units of allogeneic blood transfused intraoperatively
Time Frame: Day 1 (Day of Surgery)
Day 1 (Day of Surgery)
Units of allogeneic blood transfused postoperatively
Time Frame: Day 1 (Day of Surgery)
Day 1 (Day of Surgery)
Duration of pressor use
Time Frame: 1 Day (Day of Surgery)
1 Day (Day of Surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Darryl Lau, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

June 28, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-00406

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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