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Sponsored by: |
Centre Hospitalier Universitaire de Saint Etienne |
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Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Hip Fracture |
Drug: Tranexamic acid (Exacyl) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Double-Blind, Efficacy Study, Parallel Assignment, Placebo Control, Randomized, Treatment |
Official Title: | Efficacy of Tranexamic Acid on Perioperative Blood Loss During Hip Fracture Surgery. |
Enrollment: | 110 |
Study Start Date: | April 2005 |
Study Completion Date: | February 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
Exacyl
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Drug: Tranexamic acid (Exacyl)
15 mg/kg IV (in the vein), just before surgery and 3 hours after surgery
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2: Placebo Comparator
Physiologic serum
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Drug: Placebo
NaCl 9‰, 0,15 ml/kg IV (in the vein), just before surgery and 3 hours after surgery.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
France, Loire | |
Chu Saint-Etienne | |
SAINT-ETIENNE, Loire, France, 42055 |
Principal Investigator: | Paul Zufferey, Doctor | CHU Saint-Etienne |
Study ID Numbers: | 0401129, DGS 2005-01094 |
Study First Received: | May 17, 2006 |
Last Updated: | August 1, 2007 |
ClinicalTrials.gov Identifier: | NCT00327106 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency; France: French Data Protection Authority |
fondaparinux hip fracture tranexamic acid transfusion |
Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Fondaparinux Tranexamic Acid Hemorrhage Hemostatics |
Org 31540 Hip Fractures Femoral Fractures Antiplasmin Fibrin Modulating Agents Antifibrinolytic Agents Leg Injuries |
Antifibrinolytic Agents Coagulants Molecular Mechanisms of Pharmacological Action Hematologic Agents Fractures, Bone Wounds and Injuries Disorders of Environmental Origin Tranexamic Acid |
Hip Injuries Pharmacologic Actions Hemostatics Hip Fractures Femoral Fractures Fibrin Modulating Agents Therapeutic Uses Leg Injuries |