Arthroplasty Complications, Hemorrhage Postoperative, Total Blood Loss
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
DRUGTranexamic acid injection
Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded randomized controlled trial. Patient, anesthesiologist and surgeon are blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
\- ASA physical status 1, 2 and 3 scheduled for primary total hip arthroplasty
Exclusion criteria
* Renal failure with serum creatinine level higher than 1,40 mg/dL * Thromboembolic events in last 12 months before surgery * Pregnancy * Congenital or acquired coagulation diseases * History of gastric surgery that could lead to malabsorption * Diabetic gastro-paresis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total blood loss | First 48 hours after surgery | Peroperative (suction) and postoperative (drainage) total blood loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum concentration of tranexamic acid | 2 hours after oral administration | Monitoring of serum dosage of tranxemaic acid in randomized subpopulation of each group |
| Serum hemoglobin variation | 24 hours after surgery | Variation of serum hemoglobin between preoperative and postoperative period |
| Incidence of blood transfusion | 72 hours after surgery | Incidence of blood transfusion in two groups |
| Incidence of thromboembolic complications | 72 hours after surgery | Incidence of thromboembolic complications such as pulmonary embolism or deep venous thrombosis |
| Length of hospitalisation stay | 1 week after surgery | Difference between two groups of total hospitalisation days |
Countries
Belgium
Outcome results
None listed