Hip Fracture
Conditions
Keywords
hip fracture, transfusion, tranexamic acid, fondaparinux
Brief summary
The purpose of this study is to assess the efficacy of tranexamic acid in hip fracture surgery on the reduction of allogeneic red blood cell transfusion.
Detailed description
Studies in hip and knee arthroplasty (scheduled surgery) have shown that tranexamic acid decreases allogeneic red blood cell transfusion. In hip fracture surgery, an emergent procedure, transfusion is frequent. Transfusion increases adverse events such as postoperative bacterial infection and venous thrombosis. The purpose of this study is to assess the efficacy of tranexamic acid, an anti-fibrinolytic agent, in hip fracture surgery on the reduction of allogeneic red blood cell transfusion. The trial will also evaluate if the reduction in transfusion will be associated with less postoperative infection and without an increase in the thrombotic risk. Patients with an isolated hip fracture of less than 48 hours will be randomized to either tranexamic acid 15mg/kg IV at skin incision and three hours later or saline.Patients will receive fondaparinux for prophylaxis of venous thrombosis.
Interventions
DRUGTranexamic acid (Exacyl)
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
DRUGPlacebo
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient requiring surgery for an isolated hip fracture of less than 48 hours
Exclusion criteria
* Contraindication to tranexamic acid * Contraindication to fondaparinux * Contraindication to general anesthesia associated with a femoral nerve block * pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of patients receiving the transfusion of at least one unit of allogeneic red blood cell | between the begining of surgery (day 1) and the eighth post-operative day (day 8) |
Secondary
| Measure | Time frame |
|---|---|
| number of patients receiving the transfusion of at least one unit of allogeneic red blood cell | between the administration of fondaparinux for venous thrombosis prophylaxis(8 hours after end of surgery on day 1) and the eighth post-operative day (day 8) |
| post-operative major hemorrhage | day 8 |
| post-operative blood loss | untill day 8 |
| post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection) | untill six weeks |
| thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis) | untill six weeks |
Countries
France
Outcome results
None listed