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Tranexamic Acid Use in Acute Hip Fractures

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ClinicalTrials.gov Identifier: NCT02947529
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):
Carilion Clinic

Brief Summary:

BACKGROUND: Tranexamic acid (TXA) has been used widely for the reduction of post operative blood loss for various orthopaedic procedures including but not limited to total hip arthroplasty and total knee arthroplasty. A recent multihospital meta-analysis conducted in 2013 showed that patients who received TXA showed a significant reduction in post-operative transfusion (20.1% to 7.7%). The procedures the investigators will be evaluating are the intramedullary nail for intertrochanteric fracture and hip hemiarthroplasty. These procedures are similar to the total hip or knee replacement in that they can result in significant blood loss that requires a post operative transfusion.

STUDY PURPOSE: To determine the efficacy of TXA to decrease the rate of post-operative transfusion for acute hip fractures repaired with the following two methods, intramedullary nailing for intertrochanteric fracture and hemiarthroplasty.

METHODS: The model for the study is a prospective randomized control trial. Patients will be placed in one of two arms of the study after passing our inclusion criteria. The arms will be for either the intramedullary nailing for intertrochanteric fracture or for hemiarthroplasty. These two categories will be subdivided into those receiving TXA and those not receiving TXA. The patients in each category will have standard post-operative care and laboratory testing. The investigators will record the patients in either arm of the study, whether it be no TXA or TXA, who require post-operative transfusion within 1 week of the operation.


Condition or disease Intervention/treatment Phase
Acute Hip Fractures Drug: Tranexamic Acid Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: The Use of Tranexamic Acid to Reduce the Need for Transfusion 1 Week Post-operatively for Hemiarthroplasty or Intramedullary Nailing Needed to Correct Acute Hip Fractures
Study Start Date : August 2015
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hemiarthroplasty
Patients are placed into this arm based on the type of surgery performed, they are randomized to either receive tranexamic acid or a placebo
Drug: Tranexamic Acid
Other: Placebo
Experimental: Intramedullary nail
Patients are placed into this arm based on the type of surgery performed, they are randomized to either receive tranexamic acid or a placebo
Drug: Tranexamic Acid
Other: Placebo



Primary Outcome Measures :
  1. Transfusion reduction rate [ Time Frame: 1 week ]
    Determine the efficacy of Tranexamic Acid (TXA) in the reduction of allogenic blood transfusion within 1 week following either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.


Secondary Outcome Measures :
  1. Tranexamic acid post operative complications [ Time Frame: 1 year ]
    Determine what effect TXA has on post-operative complications within 1 year following surgery for either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture

Exclusion Criteria:

  • Prothrombotic state
  • Cardiac stent within the past year with corresponding antiplatelet therapy
  • Mechanical heart valves
  • Deep vein thrombosis history
  • Aortic stenosis
  • Currently on Coumadin
  • Malignancy
  • Kidney dialysis
  • Non-English speaking patients
  • Medications contraindicated with tranexamic acid.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02947529


Locations
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United States, Virginia
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic

Publications:
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Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT02947529     History of Changes
Other Study ID Numbers: MD2016
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Carilion Clinic:
Hemiarthroplasty
Intramedullary nail
Tranexamic acid
Transfusion
Additional relevant MeSH terms:
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Tranexamic Acid
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants