To find noninferiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss and serum concentration during primary total hip arthroplasty.
Tranexamic acid is an anti-fibrinolytic drug, recommended in total hip arthroplasty to reduce peroperative and postoperative hemorrhagic complications. The original character of our study lies in the serum dosage of tranexamic acid, allowing to correlate the primary objective (blood loss) with this one. The investigators will focus on the reduction of the risks associated with the administration of intravenous medicines, the economic aspect and the ease of use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
230
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
CHU de Liège
Liège, Belgium
Total blood loss
Peroperative (suction) and postoperative (drainage) total blood loss
Time frame: First 48 hours after surgery
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 2 hours after oral administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 6 hours after oral administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 30 minutes after intravenous administration
Serum concentration of tranexamic acid
Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group
Time frame: 4 hours after intravenous administration
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Time frame: 24 hours after surgery
Serum hemoglobin variation
Variation of serum hemoglobin between preoperative and postoperative period
Time frame: 72 hours after surgery
Incidence of blood transfusion
Incidence of blood transfusion in two groups
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Time frame: 72 hours after surgery
Incidence of thromboembolic complications
Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis
Time frame: 72 hours after surgery
Length of hospitalisation stay
Difference between two groups of total hospitalisation days
Time frame: 1 week after surgery