Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

NCT05925426 | Completed

• 1 other identifier: 22-00406
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  Day 1 (Day of Surgery)

• Elongation Index (Deformability)

  Ektacytometry will be employed to measure elongation index of salvaged RBCs.

  Day 1 (Day of Surgery)

• Critical Shear Stress (Aggregation)

  Ektacytometry will be employed to measure critical shear stress of salvaged RBCs.

  Day 1 (Day of Surgery)

Secondary Outcomes (7)

• Standardized Quantified Blood Loss (mL)

  Day 1 (Day of Surgery)

• Use of Cell Saver

  Day 1 (Day of Surgery)

• Volume (mL) collected via Cell Saver

  Day 1 (Day of Surgery)

• Units of autologous blood transfused intraoperatively

  Day 1 (Day of Surgery)

• Units of allogeneic blood transfused intraoperatively

  Day 1 (Day of Surgery)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (1)

• 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.

  PMID: 39087785 DERIVED

Study Officials

• Darryl Lau, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: June 29, 2023
• Study Start: July 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)