NCT04372173

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Military Institute od Medicine National Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Arthroplasty, Replacement
• Coagulation Factors

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-01
• Primary completion: 2018-04-30
• Completion: 2020-01-31
• First posted: 2020-05-01
• Last updated: 2020-05-01

Locations

1 site across 1 country: Poland