NCT02736383

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 13, 2016

Completed
18 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

1.2 years

First QC Date

March 29, 2016

Last Update Submit

September 21, 2023

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

  • Blood Transfusion Rate

    Blood transfusion rates during the patients hospital stay will be assessed.

    6 weeks

Secondary Outcomes (3)

  • Hospital Length of stay

    6 weeks

  • Post operative complications

    6 weeks

  • Hospitalization costs

    6 weeks

Study Arms (2)

Tranexamic Acid

Patients that receive 2 gm TXA during surgery

No Tranexamic Acid

Patients that receive no TXA during surgery

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with hip fractures

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Blake W Miller, DO

    Corewell Health West

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 13, 2016

Study Start

May 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share