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Completed

NCT Number: NCT02947529

Tranexamic Acid Use in Acute Hip Fractures

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.

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Key information

Conditions

Acute Hip Fractures

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

About this study

This is a prospective randomized control trial. Patients scheduled for either intramedullary nailing for intertrochanteric fractures or for hemiarthroplasty will be selected for the study population.

The proposed research is needed to bridge the gap between the efficacy of TXA in elective, non-emergency procedures (such as total knee arthoplasty and total hip arthroplasty) and its efficacy in emergent acute hip fracture interventions. This study will use intravenous TXA (1g pre-op and 1g post-op) to study its effect on both the reduction of blood loss during intramedullary nail for intertrochanteric fractures and hemiarthroplasty procedures, and the subsequent reduction in the rate of blood transfusion in this patient population.

Both study and control groups will have standard post-operative care and laboratory testing and will be followed for one year post-operatively to record adverse events.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tranexamic Acid

Drug

intravenous dose

Other names: TXA

Placebo

Other

intravenous dose

Other names: Saline

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Oct 28, 2016
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.