Hip FracturesPhase 2NCT03182751
Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement
A Phase 2 study testing Tranexamic Acid (TXA) in people with Hip Fractures and Intertrochanteric Fractures, run by Mayo Clinic at 1 site in United States.
Trial summary
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Intertrochanteric Fractures
- What is being tested?
- Tranexamic Acid (TXA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2018to 24 May 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AO/OTA fracture classification 31A
- Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
- Low energy, isolated injury
Who cannot join
- Intracapsular hip fractures: AO/OTA fracture classification 31B-C
- Polytrauma patients
- Creatinine clearance less than 30 mL/min
- History of unprovoked VTE and/or recurrent VTE
- Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
- Pregnancy or breastfeeding (pregnancy tests will be performed on all patients of child-bearing potential)
Show all 10Show fewer
- History of CVA, MI, or VTE within the previous 30 days
- Coronary stent placement within the previous 6 months
- Disseminated intravascular coagulation
- Intracranial hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
Read the detailed description
The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.
- Conditions
- Hip Fractures, Intertrochanteric Fractures
- Being tested
- Tranexamic Acid (TXA), Placebo
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
Also called Cyklokapron
Intravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours
PlaceboDrug
Looks exactly like the study drug, but it contains no active ingredient
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Arm (TXA) | Active comparator | Subjects will be treated with early administration of TXA in the Emergency Department Receives: Drug: Tranexamic Acid (TXA) |
| Control Arm | Placebo comparator | Subjects will be treated with a placebo in the Emergency Department Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.
Measured: Length of hospitalization (approximately 3 to 5 days)
Secondary outcomes (7)
Number of Units of Packed Red Blood Cells Transfused
Number of units of packed red blood cells transfused per patient
Measured: Length of hospitalization (approximately 3 to 5 days)
Calculated Blood Loss
Total blood loss per patient measured in milliliters (mL)
Measured: Length of hospitalization (approximately 3 to 5 days)
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
Number of subjects to experience symptomatic Venous Thromboembolism (VTE)
Measured: Within 6 months of surgery
Wound Complications
Number of subjects diagnosed with a wound complication
Measured: Within 6 months of surgery
(Myocardial Infarction) MI Diagnosed
Number of subjects diagnosed with a myocardial infarction
Measured: Within 6 months of surgery
Cerebrovascular Accident (CVA) Diagnosed
Number of subjects diagnosed with a cerebrovascular accident
Measured: Within 6 months of surgery
All-cause Mortality
Number of subject deaths
Measured: At 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start2 Apr 2018
- Primary completion24 May 2022
- Study completion24 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (\<75 vs. ≥75) and body mass index (\<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brandon James Yuan, Mayo Clinic
- Investigators
- Brandon Yuan, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182751
- Sponsor's protocol ID
- 16-004988
- Status last verified
- Mar 2023
- First submitted
- 7 Jun 2017
- Last updated
- 30 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share IPD with other researchers that are outside of the primary listed researchers within the primary institution where the investigation is being performed. While we intend the share the overall results of the study through peer review, we do not have our institution's IRB approval to share individual participant data outside of the institution.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Early Administration of Tranexamic Acid Reduce Blood Loss and Perioperative Transfusion Requirement in Low Energy Hip Fracture Patients?
- ClinicalTrials.gov ID
- NCT03182751
- Acronym / sponsor ID
- 16-004988
- Conditions
- Hip Fractures, Intertrochanteric Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 24 May 2022 (actual)
- Study completion
- 24 May 2022 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Posted 30 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intertrochanteric hip fractures typically result in blood loss from the fracture and require surgery that can cause further blood loss. This study is being done to look at a medication called tranexamic acid which may reduce blood loss and the need for blood transfusions associated with surgery.
Detailed description
The use of TXA in orthopedic trauma patients is an area of current research interest. A 2010 prospective randomized, controlled trial of perioperative TXA demonstrated reduction in transfusion requirements for intertrochanteric hip fractures treated with short, cephalomedullary nails. This was clinically, though not statistically, significant. Investigators recently conducted a randomized, controlled trial at this institution to evaluated the use of TXA in patients with femoral neck fractures treated with hemiarthroplasty or total hip arthroplasty and found clinically, albeit not statistically, significant reduction in transfusion requirement (accepted for publication). Perhaps tempering the effect seen with perioperative administration of TXA is the blood loss that occurs prior to surgery, the so-called "hidden" blood loss that can be as substantial as 1/3 of total blood loss from a hip fracture. This raises the question whether administration of tranexamic acid at the time of initial presentation after fracture could improve the perioperative care of these patients by decreasing the proportion of patients requiring transfusion and decreasing total blood loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized into one of two study groups: TXA administration (treatment) or placebo (control). In order to ensure balance on the subject demographics between the two study groups, the subjects will be stratified on gender, age group (<75 vs. ≥75) and body mass index (<30 vs. ≥30). Within each stratum, subjects will be assigned to either the treatment group or control group using an electronic dynamic allocation program housed in a computer application developed by personnel in the Division of Biomedical Statistics and Informatics.
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Arm (TXA) | Active comparator | Drug: Tranexamic Acid (TXA)Subjects will be treated with early administration of TXA in the Emergency Department |
| Control Arm | Placebo comparator | Drug: PlaceboSubjects will be treated with a placebo in the Emergency Department |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- AO/OTA fracture classification 31A
- Surgically treated with sliding hip screw or cephalomedullary nail (short or long)
- Low energy, isolated injury
Key exclusion criteria (10 listed)
- Intracapsular hip fractures: AO/OTA fracture classification 31B-C
- Polytrauma patients
- Creatinine clearance less than 30 mL/min
- History of unprovoked VTE and/or recurrent VTE
- Known history of Factor V Leiden, protein C/S deficiency, prothrombin gene mutation, anti-thrombin deficiency, anti-phospholipid antibody syndrome, lupus anticoagulant
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 Acid (TXA)Also: CyklokapronIntravenously via bolus dose of 1g over ten minutes and an additional 1g over the subsequent 8 hours | Drug | Tranexamic Acid Arm (TXA) |
| PlaceboLooks exactly like the study drug, but it contains no active ingredient | Drug | Control Arm |
Primary outcome
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells
Time frame: Length of hospitalization (approximately 3 to 5 days)
Transfusion will be considered for all patients with hemoglobin values of less than 8 g/dL with persistent symptoms or history of significant cardiac disease that may render the patient less able to compensate for significant anemia. Blood transfusion will be considered in all patients with hemoglobin less than 7 g/dL, regardless of symptoms.
7 secondary outcomes
Number of Units of Packed Red Blood Cells Transfused
Time frame: Length of hospitalization (approximately 3 to 5 days)
Calculated Blood Loss
Time frame: Length of hospitalization (approximately 3 to 5 days)
Number of Subjects to Experience Symptomatic Venous Thromboembolism (VTE)
Time frame: Within 6 months of surgery
Wound Complications
Time frame: Within 6 months of surgery
(Myocardial Infarction) MI Diagnosed
Time frame: Within 6 months of surgery
Cerebrovascular Accident (CVA) Diagnosed
Time frame: Within 6 months of surgery
All-cause Mortality
Time frame: At 6 months after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No. We do not plan to share IPD with other researchers that are outside of the primary listed researchers within the primary institution where the investigation is being performed. While we intend the share the overall results of the study through peer review, we do not have our institution's IRB approval to share individual participant data outside of the institution.
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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.
Brandon Yuan, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid (TXA) in people with Hip Fractures and Intertrochanteric Fractures, run by Mayo 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 3 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 30 Mar 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Transfused at Least 1 Unit of Packed Red Blood Cells (time frame: Length of hospitalization (approximately 3 to 5 days)). 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 30 Mar 2023.