NCT01326403

Tranexamic Acid in Hip Fracture Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Michal Roll PhD,MBA · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized controlled trial comparing the use of tranexamic acid to placebo in patients admitted to hospital with a hip fracture.

Detailed description

1. transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection 2. Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding. 3. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty. 4. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state. 5. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.

Conditions

• Closed Fracture of Hip

Interventions

Type	Name	Description
DRUG	Tranexamic acid	GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours. GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours. Group C - A control group will only receive placebo in the emergency room and in the OR.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-03-30
• Last updated: 2012-06-07

Locations

1 site across 1 country: Israel