A Comprehensive Evaluation of Thrombotic/Fibrinolytic Activation Before and After Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes of serum fibrinogen
研究概览
简要总结
The objective of the study was to analyze both the concentration and the activity of the clotting factors, D-dimer levels, as well as fibrinogen concentration in patients who underwent primary total hip arthroplasty due to idiopathic arthrosis.
Blood loss is often related to perioperative period and may result in decrease of concentration of coagulation factors, which in turn may lead to increased bleeding. We analyzed data of thirty patients scheduled for primary hip arthroplasty: the activity of clotting factors II, VIII, X, as well as fibrinogen concentration in the following time points: (i) before surgery, (ii) six hours after the procedure, and (iii) two, (iv) four, and (v) six days after the operation. All laboratory tests were performed using automatic analyzer. At the same time intervals, an immunoenzymatic assay was used to determine D-dimer levels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients qualified for primary hip arthroplasty for idiopathic osteoarthritis
排除标准
- •hip osteoarthritis because of non-idiopathic etiology
- •history of venous thromboembolism or arterial embolism
- •anticoagulation treatment,
- •coagulopathy
- •infection, and
- •renal failure defined as a creatinine clearance below 50 ml/minute.
结局指标
主要结局
Changes of serum fibrinogen
时间窗: This measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Serum fibrinogen concentration will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Changes of coagulation factor VIII
时间窗: This measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operationixth day after the operation
Activity of the coagulation factor VIII will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Changes of coagulation factor II
时间窗: This measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Activity of the coagulation factor II will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Changes of coagulation factor X
时间窗: This measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Activity of the coagulation factor X will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Changes of D-dimer
时间窗: This measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
Blood concentration of the D-dimer will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operation
次要结局
未报告次要终点
研究者
Dariusz Tomaszewski
MD, PhD, Adjunct Professor
Military Institute od Medicine National Research Institute