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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04372173
Acronym
CloFaTHA
Enrollment
30
Registered
2020-05-01
Start date
2018-02-01
Completion date
2020-01-31
Last updated
2020-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Coagulation Factors

Keywords

total hip arthroplasty, coagulation factors, venous thromboembolism

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.

Interventions

DIAGNOSTIC_TESTanalysis 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.

Sponsors

Military Institute od Medicine National Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Changes of serum fibrinogenThis measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operationSerum 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 IIThis measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operationActivity 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 VIIIThis 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 operationActivity 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 XThis measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operationActivity 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-dimerThis measure will be measured (1) before surgery, (2) six hours after the procedure; (3) second, (4) fourth, and (5) sixth day after the operationBlood 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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026