Acute Hip FracturesPhase 4NCT02947529
Tranexamic Acid Use in Acute Hip Fractures
A Phase 4 study testing Tranexamic Acid in people with Acute Hip Fractures, run by Carilion Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Hip Fractures
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 22 May 2022
- Phase
- Phase 4
- 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
Who may be able to join
- Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture
Who cannot join
- Prothrombotic state
- Cardiac stent within the past year with corresponding antiplatelet therapy
- Mechanical heart valves
- Deep vein thrombosis history
- Aortic stenosis
- Currently on Coumadin
Show all 10Show fewer
- Malignancy
- Kidney dialysis
- Non-English speaking patients
- Medications contraindicated with tranexamic acid.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, 24014
About this study
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
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.
Read the detailed description
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.
- Conditions
- Acute Hip Fractures
- Being tested
- Tranexamic Acid, Placebo
- Keywords
- Hemiarthroplasty, Intramedullary nail, Tranexamic acid, Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called TXA
intravenous dose
PlaceboOther
Also called Saline
intravenous dose
| Study group | Role | What they receive |
|---|---|---|
| Hemiarthroplasty - Placebo | Placebo comparator | Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo Receives: Other: Placebo |
| Intramedullary nail - Tranexamic Acid | Experimental | Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid Receives: Drug: Tranexamic Acid |
| Hemiarthroplasty - Tranexamic Acid | Experimental | Patients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid Receives: Drug: Tranexamic Acid |
| Intramedullary nail - Placebo | Placebo comparator | Patients are placed into this arm based on the type of surgery performed and are randomized to receive placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfusion reduction rate
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.
Measured: 1 week
Secondary outcomes (1)
Tranexamic acid post operative complications
Determine what effect TXA has on post-operative complications within 1 year following surgery for either hemiarthroplasty or intramedullary nailing for intertrochanteric fracture.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startAug 2015
- Primary completion4 Feb 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Hip FracturesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects undergoing surgery for acute hip fractures with a long trochanteric femoral nail (TFN) or hemiarthroplasty will randomized 50:50 to receive 1 dose of either tranexamic acid (TXA) or saline placebo solution prior to surgery and 1 dose during wound closure.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trevor Owen, Carilion Clinic
- Investigators
- Trevor Owen, MD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02947529
- Sponsor's protocol ID
- MD2016
- Status last verified
- Feb 2023
- First submitted
- 13 Oct 2016
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.
PubMed 25116268
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02947529
- Acronym / sponsor ID
- MD2016
- Conditions
- Acute Hip Fractures
- Keywords
- Hemiarthroplasty, Intramedullary nail, Tranexamic acid, Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 28 Oct 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Subjects undergoing surgery for acute hip fractures with a long trochanteric femoral nail (TFN) or hemiarthroplasty will randomized 50:50 to receive 1 dose of either tranexamic acid (TXA) or saline placebo solution prior to surgery and 1 dose during wound closure.
| Arm | Type | Receives |
|---|---|---|
| Hemiarthroplasty - Placebo | Placebo comparator | Other: PlaceboPatients are placed into this arm based on the type of surgery performed and are randomized to receive placebo |
| Intramedullary nail - Tranexamic Acid | Experimental | Drug: Tranexamic AcidPatients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid |
| Hemiarthroplasty - Tranexamic Acid | Experimental | Drug: Tranexamic AcidPatients are placed into this arm based on the type of surgery performed and are randomized to receive tranexamic acid |
| Intramedullary nail - Placebo | Placebo comparator | Other: PlaceboPatients are placed into this arm based on the type of surgery performed and are randomized to receive placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Geriatric patients age 65 or older who require surgery for a low energy trauma hip fracture
Key exclusion criteria (10 listed)
- Prothrombotic state
- Cardiac stent within the past year with corresponding antiplatelet therapy
- Mechanical heart valves
- Deep vein thrombosis history
- Aortic stenosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: TXAintravenous dose | Drug | Hemiarthroplasty - Tranexamic Acid, Intramedullary nail - Tranexamic Acid |
| PlaceboAlso: Salineintravenous dose | Other | Hemiarthroplasty - Placebo, Intramedullary nail - Placebo |
Primary outcome
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.
1 secondary outcome
Tranexamic acid post operative complications
Time frame: 1 year
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 21 Feb 2023.
- Background: PubMed 25116268Poeran J, Rasul R, Suzuki S, Danninger T, Mazumdar M, Opperer M, Boettner F, Memtsoudis SG. Tranexamic acid use and postoperative outcomes in patients undergoing total hip or knee arthroplasty in the United States: retrospective analysis of effectiveness and safety. BMJ. 2014 Aug 12;349:g4829. doi: 10.1136/bmj.g4829.
- 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.
Trevor Owen, MD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid in people with Acute Hip Fractures, run by Carilion Clinic at 1 site in United States.
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 1 inclusion and 10 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 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Transfusion reduction rate (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02947529, which also lists 1 linked publication.
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 21 Feb 2023.