Tranexamic Acid in Hip Fracture Patients

Closed Fracture of Hip Clinical Trial

Official title:

Tranexamic Acid in Hip Fracture Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01326403
• Other study ID #: TASMC-11-ES-0129-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2011
• Last updated: June 6, 2012
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2012
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Closed Fracture of Hip
• Fractures, Bone
• Fractures, Closed
• Hip Fractures

Intervention

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.

Locations

Country	Name	City	State
Israel	Sourasky Medical Center	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Michal Roll PhD,MBA	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total amount of blood loss per patient from admission to day 5 post-op		5 DAYS	No
Secondary	Number of packed cell transfusion per patient.		5 DAYS	No
Secondary	Initial functional outcome and feeling of well-being.		5 days	No
Secondary	thromboembolic events		5 days	Yes
Secondary	post-operative bacterial infection		5 days	No
Secondary	30 day mortality rate		30 days	Yes