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

Completed

• Conditions: Arthroplasty, Replacement; Coagulation Factors

• Registration Number: NCT04372173
• Lead Sponsor: Military Institute od Medicine National Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-04-30
• Study Completion: 2020-01-31
• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study First Submitted QC: 2020-04-29
• Last Update Submitted: 2020-04-29
• Study First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes of serum fibrinogen	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	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	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	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	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

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Therapy; 🇵🇱 Warsaw, Poland