Hip Arthroplasty
Conditions
Keywords
hip arthroplasty, Tranexamic acid, randomized control trial
Brief summary
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over height hours on blood loss.
Detailed description
The purpose of this study is to compare a single preoperative dose of 1g of tranexamic acid (TXA) versus a preoperative dose of 1g of TXA followed by a continuous infusion of 1g over eight hours on blood loss. The efficacy of TXA on blood loss is greatly influenced by the timing of its administration relative to surgery. In total hip arthroplasty, TXA should be started before surgery. However the optimal duration of TXA administration in hip arthroplasty is unknown. Numerous studies have shown that a single preoperative administration of TXA is effective. Yet indirect comparisons indicate a higher efficacy of TXA started before surgery and followed with a continuous infusion or repeated boluses. Our hypothesis is that a single preoperative administration of TXA is not sufficient to maintain therapeutic concentrations of TXA in the postoperative period. In addition a pharmacokinetic/pharmacodynamic study will be performed to identify the contribution of TXA plasma concentration as a predictor of blood loss.
Interventions
DRUGActive comparator : Tranexamic Acid (Exacyl)
* 1g Exacyl Intra Venous, just before surgery * Then infusion of 1g of Exacyl over eight hours .
DRUGPlacebo comparator : physiologic serum
* 1g Intra Venous just before surgery * Then infusion of 1g of physiologic serum over eight hours
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requiring hip arthroplasty in first line, except recent hip fracture (less than 3 months) * Consent of the patient or a family member or the support person.
Exclusion criteria
* Contraindication to tranexamic acid. * Contraindication to apixaban. * Pregnancy. * Patient receiving a curative anticoagulating treatment in the preoperative period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculated volume of blood losses in the peroperative period. | between the beginning of surgery and the fifth day | It requires the sampling of haemoglobin at the beginning of surgery and in the fifth day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the patients' percentage that will receive the transfusion of at least one allogenic globular sediment | between D1 (day of surgery) and D5 (the fourth postoperative day) | the patients' percentage that will receive the transfusion of at least one allogenic globular sediment in the peroperative period. |
| incidence of symptomatic thrombotic events and death | in 6 weeks | combined criteria of venous events (deep venous thrombosis or pulmonary embolism), arterial events (acute coronary syndrome, stroke or peripheral arterial thrombosis) and death |
| tranexamic acid pharmacokinetic analyses | from the beginning of surgery up to 8 hours | non linear mixt effect model |
Countries
France
Outcome results
None listed