An Evaluation of Clotting Factor Activity Before and After Total Hip Arthroplasty

Study Overview
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Brief Summary
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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.

Official Title
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A Comprehensive Evaluation of Thrombotic/Fibrinolytic Activation Before and After Total Hip Arthroplasty

Conditions
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Arthroplasty, Replacement, Coagulation Factors

Intervention / Treatment
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* Diagnostic Test: analysis of the concentration of the clotting factors in patients who underwent primary hip arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients qualified for primary hip arthroplasty for idiopathic osteoarthritis Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: analysis of the concentration of the clotting factors in patients who underwent primary hip arthroplasty|Blood samples were taken before surgery, 6 hours, two, four, and six days after the procedure. Venous blood samples were taken from peripheral veins. All analyzed parameters (fibrinogen, factor II, factor VIII, factor X, D-dimer) were determined using an ACL TOP 500 CTS automated coagulation analyzer. All patients were operated on by a single surgical team, with cementless hip replacements implanted, and without tranexamic acid administered in the perioperative period. All patients underwent venous thromboembolic complications prophylaxis. The following data were collected: age, body mass index, gender, perioperative risk assessment scale according to the American Society of Anesthesiologists score, blood transfusions, hemoglobin levels before surgery and two days post-surgery, instances of thromboembolic complications. Because of the observational nature of this study no changes in the treatment of patients were made.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of serum fibrinogen | 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 | 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 | 
| Changes of coagulation factor II | 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 | 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 | 
| Changes of coagulation factor VIII | 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 | 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 | 
| Changes of coagulation factor X | 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 | 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 | 
| Changes of D-dimer | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total hip arthroplasty, coagulation factors, venous thromboembolism