Diffrence in Thromboprofilaksis in Elderly Ostoepenic Hip Fractures According to Mobility Status by Genetic Analysis

NCT06959017 | Active Not Recruiting DMC

• 1 other identifier: 01.04.2024-65
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fracture is a common and severe disease in elderly patients. The question of the study is whether elderly patients with severe osteopenia have significantly lower levels of the collagen-binding protein Hsp47 than relatively mobile patients due to advanced immobility before the fracture, and whether they participants have a similar risk of VTE to the normal population despite having had a hip fracture and surgery.

Conditions

Hip Fracture of Intertrochanteric Type; Thromboembolic Event; Osteopenia; Thrombosis Embolism

Keywords

hip fracture; serpinh1; thromboembolism; rock1

Outcome Measures

Primary Outcomes (1)

• HSP 47

  HSP 47 (SERPİNH1, ROCK1) gene expression analysis

  Gene expression analysis will be performed once samples are collected from all participants.

Secondary Outcomes (1)

• Thromboembolie

  from fracture occur up to one year

Study Arms (3)

Sedentary

ACTIVE COMPARATOR

This group is consist of the patients with pre-fracture mobility score 3-4-5

Genetic: Gene Expression Analysis

Active

EXPERIMENTAL

This group is consist of the patients with pre-fracture mobility score 1-2

Genetic: Gene Expression Analysis

Control

EXPERIMENTAL

This group is consist of the volunteered healty people which \>65 years of age

Genetic: Gene Expression Analysis

Interventions

Gene Expression Analysis GENETIC

Each subject analysed for SERPİNH1 and ROCK1 gene exppression

Active; Control; Sedentary

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• \>65 years of age
• Interthrocanteric femur fracture AO Type 31A1, 31A2, 31A3
• Patients treated proksimal femoral nail
• Minor trauma
• Fracture mobility score 1,2,3,4,5
• Inial thrombocytes count 150.000-450.000 /µL

You may not qualify if:

• Body mass index \>40
• Fracture mobility score 6 (unknown type)
• stage 4 chronic kidney disease
• Patients with rheumatological diseases
• Patients at serious risk of VTE(Venous thromboembolism) (according to the International Society on Thrombosis and Hemostasis, categorization of venous thromboembolism) :
• Active Hematologic Cancer
• Antiphospholipid syndrome
• History of recurrent thrombosis (DVT)
• Paroxysmal nocturnal hemoglobinuria

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

Prof Dr emil Tascıoglu City Hospital

Istanbul, Şişli, 34384, Turkey (Türkiye)

Location

Related Publications (1)

• Thienel M, Muller-Reif JB, Zhang Z, Ehreiser V, Huth J, Shchurovska K, Kilani B, Schweizer L, Geyer PE, Zwiebel M, Novotny J, Lusebrink E, Little G, Orban M, Nicolai L, El Nemr S, Titova A, Spannagl M, Kindberg J, Evans AL, Mach O, Vogel M, Tiedt S, Ormanns S, Kessler B, Dueck A, Friebe A, Jorgensen PG, Majzoub-Altweck M, Blutke A, Polzin A, Stark K, Kaab S, Maier D, Gibbins JM, Limper U, Frobert O, Mann M, Massberg S, Petzold T. Immobility-associated thromboprotection is conserved across mammalian species from bear to human. Science. 2023 Apr 14;380(6641):178-187. doi: 10.1126/science.abo5044. Epub 2023 Apr 13.

  PMID: 37053338 BACKGROUND

MeSH Terms

Conditions

Thromboembolism; Bone Diseases, Metabolic; Embolism and Thrombosis; Hip Fractures; Hereditary Sensory and Autonomic Neuropathies

Interventions

Gene Expression Profiling

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Genetic Techniques; Investigative Techniques

Study Officials

• İsmail Demirkale, Prof Dr

  Saglik Bilimleri Universty

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. İsmail Demirkale

Model Details: All patients undergo genetic expression analysis of HSP 47 (SERPİNH1, ROCK1) and the also classified by their mobility score before fracture. There is also a control group consist of age appropied healty adults

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 6, 2025
• Study Start: November 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

TU (1)