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

Arthroplasty, Replacement Clinical Trial

— CloFaTHA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04372173
• Other study ID #: 681006-7
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2020
• Source: Military Institute of Medicine, Poland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2020
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthroplasty, Replacement
• Coagulation Factors

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Anesthesiology and Intensive Therapy	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Military Institute of Medicine, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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