Is Thromboprotection Preserved in Elderly Ostopenic Patients Who Are Severly Immobilized Before Hip Fracture?
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- HSP 47
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>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
排除标准
- •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
研究组 & 干预措施
Sedentary
This group is consist of the patients with pre-fracture mobility score 3-4-5
干预措施: Gene Expression Analysis (Genetic)
Active
This group is consist of the patients with pre-fracture mobility score 1-2
干预措施: Gene Expression Analysis (Genetic)
Control
This group is consist of the volunteered healty people which >65 years of age
干预措施: Gene Expression Analysis (Genetic)
结局指标
主要结局
HSP 47
时间窗: Gene expression analysis will be performed once samples are collected from all participants.
HSP 47 (SERPİNH1, ROCK1) gene expression analysis
次要结局
- Thromboembolie(from fracture occur up to one year)
研究者
İsmail Demirkale
Prof. Dr. İsmail Demirkale
Saglik Bilimleri Universitesi