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Tranexamic Acid in Hip Fracture Surgery

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ClinicalTrials.gov Identifier: NCT02736383
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : July 31, 2017
Sponsor:
Information provided by (Responsible Party):
Spectrum Health Hospitals

Brief Summary:
To determine if TXA utilization is effective at reducing transfusion rates in elderly patients undergoing surgery for treatment of a hip fractures.

Condition or disease
Hip Fracture

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Study Type : Observational
Actual Enrollment : 142 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effectiveness of Tranexamic Acid (TXA) in Reducing Blood Loss in Hip Fracture Surgery
Actual Study Start Date : May 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Tranexamic Acid
Patients that receive 2 gm TXA during surgery
No Tranexamic Acid
Patients that receive no TXA during surgery



Primary Outcome Measures :
  1. Blood Transfusion Rate [ Time Frame: 6 weeks ]
    Blood transfusion rates during the patients hospital stay will be assessed.


Secondary Outcome Measures :
  1. Hospital Length of stay [ Time Frame: 6 weeks ]
    The patients length of stay in the hospital will be determined.

  2. Post operative complications [ Time Frame: 6 weeks ]
    Post operative complications will be assessed through the 6 weeks.

  3. Hospitalization costs [ Time Frame: 6 weeks ]
    Economic evaluation for inpatient and re-admission will be assessed.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hip fractures
Criteria

Inclusion Criteria:

  • Acute, isolated, unilateral femoral neck, intertrochanteric, and per trochanteric hip fractures confirmed by anteroposterior/lateral hip radiographs, computed tomography, or magnetic resonance imaging.
  • Age 65 and older
  • Low energy mechanism of injury
  • Hip fracture fixation performed within 48 hours
  • English speaking
  • Anticipated medical optimization for operative fixation
  • No other major trauma

Exclusion Criteria:

  • Retained hardware around the affected hip
  • Infection around the affected hip
  • Transfer patients with a length of stay > 24 hours at the transferring hospital
  • Diagnosis of deficient natural anticoagulation
  • Known congenital thrombophilia (Deficiency of Protein C, S, Antithrombin)
  • Known allergy to TXA
  • Patients undergoing percutaneous pinning of the hip fracture

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): NCT02736383


Sponsors and Collaborators
Spectrum Health Hospitals
Investigators
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Principal Investigator: Blake W Miller, DO Spectrum Health Hospitals

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Responsible Party: Spectrum Health Hospitals
ClinicalTrials.gov Identifier: NCT02736383     History of Changes
Other Study ID Numbers: 2016-60
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants