A Phase 3 interventional study of Tranexamic acid (Exacyl) and Placebo in Hip Fracture, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-11.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Phase 3, Interventional, and Treatment
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.
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.
2,261 studies on the registry are indexed under Fractures, Bone; 325 are open to participants now.
This study's enrollment of 110 is above the median of 69 across 1,482 interventional studies indexed under Fractures, Bone.
Browse Fractures, Bone studies →Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Exacyl
Drug: Tranexamic acid (Exacyl)
Physiologic serum
Drug: Placebo
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
Also known as: Exacyl
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Time frame: between the begining of surgery (day 1) and the eighth post-operative day (day 8)
number of patients receiving the transfusion of at least one unit of allogeneic red blood cell
Time frame: 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
Time frame: day 8
post-operative blood loss
Time frame: untill day 8
post-operative bacterial infection (combined criteria of wound infection, bronchopulmonary infection and urinary tract infection)
Time frame: untill six weeks
thromboembolic events (combined criteria of venous thrombo-embolism, stroke, acute coronary syndrome and peripheral arterial thrombosis)
Time frame: untill six weeks
This study is completed, as verified in Jun 2009. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne