Chu Saint-Etienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
NCT Number: NCT00327106
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42055, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
Other names: Exacyl
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
Time frame: between the begining of surgery (day 1) and the eighth post-operative day (day 8)
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)
Time frame: day 8
Time frame: untill day 8
Time frame: untill six weeks
Time frame: untill six weeks
Centre Hospitalier Universitaire de Saint Etienne
Other
Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery.
Acronym: THIF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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