Altered Hemorology in Adolescent Idıopathic Scoliosis

NCT07102862 | Completed

• 2 other identifiers: AHIAIS-2025SBU-2025
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate potential alterations in hemorheological parameters in adolescents with idiopathic scoliosis (AIS) compared to healthy controls. A total of 30 AIS patients and 30 age- and sex-matched healthy individuals will be evaluated through clinical, radiological, and laboratory assessments. Hematocrit, plasma and whole blood viscosity, erythrocyte deformability, and aggregation will be measured. The goal is to determine whether structural spinal deformities in AIS are associated with changes in microcirculatory blood flow properties.

Conditions

Idiopathic Adolescent Scoliosis

Keywords

Idiopathic Adolescent Scoliosis; hemorheology

Outcome Measures

Primary Outcomes (6)

• Plasma viscosity (PV)

  Measurement of plasma viscosity (mPa·s) using cone-plate viscometry at a shear rate of 450 s-¹.

  At baseline (single time point)

• Whole blood viscosity (WBV)

  Measurement of whole blood viscosity (mPa·s) using cone-plate viscometer at multiple shear rates (37.5 to 450 s-¹).

  At baseline (single time point)

• Erythrocyte deformability (EImax)

  Evaluation of erythrocyte elongation index (EImax) using laser-assisted ektacytometry (Lorrca MaxSis).

  At baseline (single time point)

• Erythrocyte deformability (SS1/2)

  Evaluation of shear stress at half EImax (SS1/2) using laser-assisted ektacytometry (Lorrca MaxSis).

  At baseline (single time point)

• Erythrocyte aggregation (AI and Tr)

  Measurement of aggregation index (AI) using Lorrca MaxSis at 37°C under standardized conditions.

  At baseline (single time point)

• Erythrocyte aggregation (Tr)

  Measurement of relaxation time (Tr) using Lorrca MaxSis at 37°C under standardized conditions.

  At baseline (single time point)

Secondary Outcomes (42)

• Correlation between Cobb angle and the Plasma viscosity (mPa·s)

  At baseline (single time point)

• Correlation between cervical lordosis angle and the Plasma viscosity (mPa·s)

  At baseline (single time point)

• Correlation between thoracic kyphosis angle and the Plasma viscosity (mPa·s)

  At baseline (single time point)

• Correlation between lumbar lordosis angle and the Plasma viscosity (mPa·s)

  At baseline (single time point)

• Correlation between angle of trunk rotation (ATR) and the Plasma viscosity (mPa·s)

  At baseline (single time point)

Study Arms (2)

Patients

10-18 years old AIS patients

Control Healthy Subjects

Sex and aged match healthy subjecyts

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This case-control study occurred at the University of Health Sciences in Istanbul from January to May 2025. Participation was voluntary, and written informed consent was obtained from both the adolescents and their legal guardians prior to data collection. Adolescents with idiopathic scoliosis will initially be recruited. An equal number of age-matched and sex-matched healthy controls will also be included. All participants will undergo the same evaluation protocol, and inclusion/exclusion criteria will be applied consistently across both groups.

You may qualify if:

• Presence of structural scoliosis with a Cobb angle greater than 10°
• Age between 10 and 18 years

You may not qualify if:

• Other types of scoliosis, such as syndromic conditions, congenital vertebral deformities, and neuromuscular scoliosis
• Presence of any diseases or conditions that may affect hemorheology, such as cardiovascular, respiratory, and hematologic diseases
• Obesity (Body mass index \[BMI\] \> 30)
• Being treated surgically for scoliosis

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead
• Saglik Bilimleri Universitesi: collaborator

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Related Links

• Lazari D, Freitas Leal JK, Brock R, Bosman G. The Relationship Between Aggregation and Deformability of Red Blood Cells in Health and Disease. Front Physiol 2020;11:288.
• Ebenuwa I, Violet P-C, Tu H, Lee C, Munyan N, Wang Y, et al. Altered RBC deformability in diabetes: clinical characteristics and RBC pathophysiology. Cardiovasc Diabetol 2024;23:370.

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

Study Officials

• Papatya Keles, professor

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 5, 2025
• Study Start: April 4, 2024
• Primary Completion: January 20, 2025
• Study Completion: June 7, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)