Clinical trial NCT06959017: Diffrence in Thromboprofilaksis in Elderly Ostoepenic Hip Fractures According to Mobility Status by Genetic Analysis
Official title: Is Thromboprotection Preserved in Elderly Ostopenic Patients Who Are Severly Immobilized Before Hip Fracture?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hip Fracture of Intertrochanteric Type
Thromboembolic Event
Osteopenia
Thrombosis Embolism
Keywords: hip fracture
serpinh1
thromboembolism
rock1
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
Collaborators: name: Sağlık Bilimleri University
First posted: 2025-05-06
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: BASIC_SCIENCE

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.

Detailed description: In this study, the investigators aimed to prospectively measure the Hsp 47 gene expression levels in patients scheduled for surgery due to intertrochanteric femur fracture and healthy volunteers in the same age group and compare the results with the literature.

Also the complications prior or after surgery will be compared.

Eligibility criteria: Inclusion Criteria:

* \>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

Exclusion Criteria:

* 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

Primary outcomes:
measure: HSP 47
timeFrame: Gene expression analysis will be performed once samples are collected from all participants.
Secondary outcomes:
measure: Thromboembolie
timeFrame: from fracture occur up to one year
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Prof Dr emil Tascıoglu City Hospital
state: Şişli
Study officials:
affiliation: Saglik Bilimleri Universty
name: İsmail Demirkale, Prof Dr
role: STUDY_CHAIR
References:
citation: 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.