Tranexamic Acid in Hip Fracture Patients

Study Overview
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Brief Summary
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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
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transfusion of allogeneic RBC's is not free of adverse events and has been associated with an increased risk of postoperative infection Tranexamic acid in trauma patients has been shown to reduce 30-day mortality. Hospital trauma protocol includes tranexamic acid in patients with major bleeding. Tranexamic acid in orthopedic elective joint reconstruction surgery has been shown to substantially decrease bleeding in knee and hip arthroplasty. in hip fracture surgery, transexamic acid reduces erythrocyte transfusion rate but may promote a hypercoagulable state. Tranexamic acid is an antifibrinolytic drug that inhibits plasminogen from turning into plasmin thereby inhibiting clot breakdown.

Official Title
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Tranexamic Acid in Hip Fracture Patients

Conditions
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Closed Fracture of Hip

Intervention / Treatment
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* Drug: Tranexamic acid


Participation Criteria
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Eligibility Criteria
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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: Vascular events within the last 2 months such as CVA, TIA, ACS, MI, DVT or arterial thrombosis. Patients receiving anticoagulation therapy with Coumadin or Plavix. Pregnancy and breastfeeding females. Previous arterial or venous thrombosis History of seizures. Creatinine >2. Oestroprogestive therapy. Multiple fractures.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>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<br>* 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.<br>* Other names: preoperative group;|
| Experimental: GROUP B<br>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<br>* 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.<br>* Other names: preoperative group;|
| Placebo Comparator: GROUP C<br>A control group will only receive placebo in the emergency room and in the OR. | Drug: Tranexamic acid<br>* 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.<br>* Other names: preoperative group;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proximal, hip, fractures