Tranexamic Acid in Hip Fracture Patients

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

Study Overview

• Status: Unknown
• Conditions: Closed Fracture of Hip
• Intervention / Treatment: Drug: Tranexamic acid

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Sourasky Medical Center
    • Contact: ELI STEINBERG, MD; Phone Number: 0524266346; Email: STEINBERGE@TASMC.HEALTH.GOV.IL
    • Contact: AMIR SHLAIFER, MD; Phone Number: 0527360803; Email: SHLAIFER.MD@GMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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.	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.; Other Names: placebo group; post injury group; preoperative group
Experimental: GROUP B; 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.	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.; Other Names: placebo group; post injury group; preoperative group
Placebo Comparator: GROUP C; A control group will only receive placebo in the emergency room and in the OR.	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.; Other Names: placebo group; post injury group; preoperative group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total amount of blood loss per patient from admission to day 5 post-op	5 DAYS

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Michal Roll PhD,MBA
• Collaborators: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: ELI SHTEINBERG, MD, Tel-Aviv Sourasky Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): June 1, 2013
• Study Completion (Anticipated): June 1, 2013

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): June 7, 2012
• Last Update Submitted That Met QC Criteria: June 6, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: fractures; hip; proximal
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Fractures, Closed; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: TASMC-11-ES-0129-CTIL