Clinical trial NCT04372173: An Evaluation of Clotting Factor Activity Before and After Total Hip Arthroplasty
Official title: A Comprehensive Evaluation of Thrombotic/Fibrinolytic Activation Before and After Total Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement
Coagulation Factors
Keywords: total hip arthroplasty
coagulation factors
venous thromboembolism
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: There were 12 men and 18 women in the study group. Mean age: 67 years. Mean body mass index: 26. Mean ASA score: II.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes of serum fibrinogen
timeFrame: 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
measure: Changes of coagulation factor II
timeFrame: 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
measure: Changes of coagulation factor VIII
timeFrame: 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
measure: Changes of coagulation factor X
timeFrame: 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
measure: Changes of D-dimer
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Department of Anesthesiology and Intensive Therapy
Study officials:
References: