Tranexamic Acid in Hip Fracture Patients

Not Applicable

• Conditions: Closed Fracture of Hip
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT01326403
• Lead Sponsor: Michal Roll PhD,MBA

Brief 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.

Study Timeline

• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Status Verified: 2012-06
• Study Start: 2012-06
• Last Update Submitted: 2012-06-06
• Last Update Posted: 2012-06-07
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients admitted to the emergency room with proximal hip fractures (31A-31B according to the Muller AO classification of fractures - long bones).
• Patients mentally capable of giving informed consent.

Exclusion Criteria

1. Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis.
2. Patients receiving anticoagulation therapy with Coumadin or Plavix.
3. Pregnancy and breastfeeding females.
4. Previous arterial or venous thrombosis
5. History of seizures.
6. Creatinine >2.
7. Oestroprogestive therapy.
8. Multiple fractures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group A	Tranexamic acid	Patients will 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	Tranexamic acid	Patients will receive 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	Tranexamic acid	A control group will only receive placebo in the emergency room and in the OR.

Primary Outcome Measures

Name	Time	Method
Total amount of blood loss per patient from admission to day 5 post-op	5 DAYS

Secondary Outcome Measures

Name	Time	Method
30 day mortality rate	30 days
Initial functional outcome and feeling of well-being.	5 days
thromboembolic events	5 days
Number of packed cell transfusion per patient.	5 DAYS
post-operative bacterial infection	5 days

Trial Locations

Locations (1)

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel