Hip FractureNCT02736383
Tranexamic Acid in Hip Fracture Surgery
An observational study of Hip Fracture, run by Corewell Health West.
Trial summary
To determine if TXA utilization is effective at reducing transfusion rates in elderly patients undergoing surgery for treatment of a hip fractures. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture
- How many people
- 142 participants
- Where
- No sites listed yet
- Study dates
- May 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients with hip fractures
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Effectiveness of Tranexamic Acid (TXA) in Reducing Blood Loss in Hip Fracture Surgery
To determine if TXA utilization is effective at reducing transfusion rates in elderly patients undergoing surgery for treatment of a hip fractures.
- Conditions
- Hip Fracture
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid | Patients that receive 2 gm TXA during surgery | |
| No Tranexamic Acid | Patients that receive no TXA during surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Transfusion Rate
Blood transfusion rates during the patients hospital stay will be assessed.
Measured: 6 weeks
Secondary outcomes (3)
Hospital Length of stay
The patients length of stay in the hospital will be determined.
Measured: 6 weeks
Post operative complications
Post operative complications will be assessed through the 6 weeks.
Measured: 6 weeks
Hospitalization costs
Economic evaluation for inpatient and re-admission will be assessed.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health West
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blake W Miller, DO, Principal investigator, Corewell Health West
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02736383
- Sponsor's protocol ID
- 2016-060
- Status last verified
- Sep 2023
- First submitted
- 29 Mar 2016
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tranexamic Acid (TXA) in Reducing Blood Loss in Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT02736383
- Acronym / sponsor ID
- 2016-060
- Conditions
- Hip Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Corewell Health WestUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 13 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if TXA utilization is effective at reducing transfusion rates in elderly patients undergoing surgery for treatment of a hip fractures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | – | –Patients that receive 2 gm TXA during surgery |
| No Tranexamic Acid | – | –Patients that receive no TXA during surgery |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients with hip fractures
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood Transfusion Rate
Time frame: 6 weeks
Blood transfusion rates during the patients hospital stay will be assessed.
3 secondary outcomes
Hospital Length of stay
Time frame: 6 weeks
Post operative complications
Time frame: 6 weeks
Hospitalization costs
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blake W Miller, DO principal investigator
Corewell Health West
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture, run by Corewell Health West.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Transfusion Rate (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.