Anterior Cruciate Ligament Rupture, Arthroscopy, Hemorrhage Postoperative, Total Blood Loss
Conditions
Brief summary
To find superiority relationship between oral and intravenous administration of tranexamic acid on peroperative and postoperative blood loss, haemarthrosis prevalence and improvement functional prognosis in anterior cruciate ligament arthroscopy.
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
DRUGOral tablet
Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
DRUGPlacebo
Oral administration of lactose tablet (placebo)
Sponsors
University of Liege
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Patient, anesthesiologist and surgeon are blinded
Intervention model description
Double blinded prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Primary arthroscopic surgery for anterior cruciate ligament reconstruction
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 |
|---|---|---|
| Assessment of haemarthrosis | First 24 hours after surgery | Postoperative (drainage) blood loss |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 24 hours after surgery | Postoperative pain score on numeric ratio scale (NRS) from 0 (no pain) to 10 (worst pain) |
| Clinical evaluation of functional recovery | 1 days after surgery | Tegner activity score from 0 (no activity) to 10 (competitive sport) |
| Length of hospital stay | First 30 days after surgery | Total days of hospitalization |
Countries
Belgium
Contacts
Primary ContactNicolas Piette, MD
Outcome results
None listed