Tranexamic Acid in Hip Fracture Patients

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Closed Fracture of Hip	Drug: Tranexamic acid	Not Applicable

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
Official Title:	Tranexamic Acid in Hip Fracture Patients
Study Start Date :	June 2012
Estimated Primary Completion Date :	June 2013
Estimated Study Completion Date :	June 2013

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures

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Primary Outcome Measures :

1. Total amount of blood loss per patient from admission to day 5 post-op [ Time Frame: 5 DAYS ]

Secondary Outcome Measures :

1. Number of packed cell transfusion per patient. [ Time Frame: 5 DAYS ]
2. Initial functional outcome and feeling of well-being. [ Time Frame: 5 days ]
3. thromboembolic events [ Time Frame: 5 days ]
4. post-operative bacterial infection [ Time Frame: 5 days ]
5. 30 day mortality rate [ Time Frame: 30 days ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	March 30, 2011
Last Update Posted:	June 7, 2012
Last Verified:	June 2012

Keywords provided by Michal Roll PhD,MBA, Tel-Aviv Sourasky Medical Center:

proximal; hip; fractures

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Fractures, Closed; Wounds and Injuries; Femoral Fractures; Hip Injuries; Leg Injuries	Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants