Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

Spinal Deformity Clinical Trial

Official title:

Defining The Quality Of Intraoperatively Salvaged Blood For Deformity Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05925426
• Other study ID #: 22-00406
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity

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)