Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

Completed

• Conditions: Spinal Deformity

• Registration Number: NCT05925426
• Lead Sponsor: NYU Langone Health

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2023-06-22
• Study First Submitted QC: 2023-06-28
• Study First Posted: 2023-06-29
• Primary Completion: 2023-06-30
• Study Completion: 2023-09-30
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Elongation Index (Deformability)	Day 1 (Day of Surgery)	Ektacytometry will be employed to measure elongation index of salvaged RBCs.
Lactate Dehydrogenase (LDH) Levels	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	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.
Critical Shear Stress (Aggregation)	Day 1 (Day of Surgery)	Ektacytometry will be employed to measure critical shear stress of salvaged RBCs.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States