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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05925426
Other study ID # 22-00406
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date December 31, 2024

Study information

Verified date April 2024
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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?


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 103
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
United States NYU Langone Health New York New York

Sponsors (1)

Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary Elongation Index (Deformability) Ektacytometry will be employed to measure elongation index of salvaged RBCs. Day 1 (Day of Surgery)
Primary Critical Shear Stress (Aggregation) Ektacytometry will be employed to measure critical shear stress of salvaged RBCs. Day 1 (Day of Surgery)
Secondary Standardized Quantified Blood Loss (mL) Day 1 (Day of Surgery)
Secondary Use of Cell Saver This will be reported in a binary manner: 0 = yes, 1 = no Day 1 (Day of Surgery)
Secondary Volume (mL) collected via Cell Saver Day 1 (Day of Surgery)
Secondary Units of autologous blood transfused intraoperatively Day 1 (Day of Surgery)
Secondary Units of allogeneic blood transfused intraoperatively Day 1 (Day of Surgery)
Secondary Units of allogeneic blood transfused postoperatively Day 1 (Day of Surgery)
Secondary Duration of pressor use 1 Day (Day of Surgery)
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