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Completed

NCT Number: NCT05925426

Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

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?

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Key information

Conditions

Spinal Deformity

Sex eligibility

All sexes

Study type

Observational

Primary location

NYU Langone Health

New York, 10016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. Elongation Index (Deformability)

    Time frame: Day 1 (Day of Surgery)

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

  4. Critical Shear Stress (Aggregation)

    Time frame: Day 1 (Day of Surgery)

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

Secondary outcomes

  1. Standardized Quantified Blood Loss (mL)

    Time frame: Day 1 (Day of Surgery)

  2. Use of Cell Saver

    Time frame: Day 1 (Day of Surgery)

    This will be reported in a binary manner: 0 = yes, 1 = no

  3. Volume (mL) collected via Cell Saver

    Time frame: Day 1 (Day of Surgery)

  4. Units of autologous blood transfused intraoperatively

    Time frame: Day 1 (Day of Surgery)

  5. Units of allogeneic blood transfused intraoperatively

    Time frame: Day 1 (Day of Surgery)

  6. Units of allogeneic blood transfused postoperatively

    Time frame: Day 1 (Day of Surgery)

  7. Duration of pressor use

    Time frame: 1 Day (Day of Surgery)

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 29, 2023
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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