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Tranexamic Acid in Hip Fracture Patients

This study is not yet open for participant recruitment.
Verified June 2012 by Tel-Aviv Sourasky Medical Center
Sponsor:
Collaborator:
Tel-Aviv Sourasky Medical Center
Information provided by (Responsible Party):
Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01326403
First received: March 21, 2011
Last updated: June 6, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
Closed Fracture of Hip
 Drug: Tranexamic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Tranexamic Acid in Hip Fracture Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Total amount of blood loss per patient from admission to day 5 post-op [ Time Frame: 5 DAYS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of packed cell transfusion per patient. [ Time Frame: 5 DAYS ] [ Designated as safety issue: No ]
  • Initial functional outcome and feeling of well-being. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • thromboembolic events [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]
  • post-operative bacterial infection [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • 30 day mortality rate [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326403

Locations
Israel
Sourasky Medical Center Not yet recruiting
Tel Aviv, Israel
Contact: ELI STEINBERG, MD     0524266346     STEINBERGE@TASMC.HEALTH.GOV.IL    
Contact: AMIR SHLAIFER, MD     0527360803     SHLAIFER.MD@GMAIL.COM    
Sponsors and Collaborators
Michal Roll PhD,MBA
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: ELI SHTEINBERG, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Michal Roll PhD,MBA, division of research and development TASMC, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01326403     History of Changes
Other Study ID Numbers: TASMC-11-ES-0129-CTIL
Study First Received: March 21, 2011
Last Updated: June 6, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Tel-Aviv Sourasky Medical Center:
proximal
hip
fractures

Additional relevant MeSH terms:
Fractures, Bone
Fractures, Closed
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
 Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013