Hip FracturesPhase 3NCT05518279
Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures
A Phase 3 study testing Tranexamic Acid Pill in people with Hip Fractures and Blood Loss, run by Henry Ford Health System.
Trial summary
The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Hip Fractures, Blood Loss
- What is being tested?
- Tranexamic Acid Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2021
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 50
- Clinical diagnosis of acute femoral neck, intertrochanteric or subtrochanteric femur fracture
Who cannot join
- anticoagulant use at time of admission to emergency department
- documented allergy to tranexamic acid
- history of deep vein thrombosis or pulmonary embolism
- hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 60)
- renal dysfunction (Creatinine > 1.5 or Glomerular Filtration Rate < 30)
- active coronary artery disease (event within 12 months)
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- history of cerebral vascular accident within 12 months
- presence of drug eluting stent
- color blindness
- active cancer
- coagulopathy (International Normalized Ratio > 1.4, Partial Thromboplastin Time > 1.4 times normal, platelets < 50,000)
About this study
Official title: Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures: A Prospective, Randomized, Double-blinded, Placebo Controlled Trial
The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.
Read the detailed description
There remains a high incidence of blood transfusion in patients following hip fractures. Tranexamic acid (TXA) has well-studied efficacy in decreasing blood loss and transfusion requirements in the context of general trauma, as well as several elective orthopaedic procedures. Although blood is lost in hip fracture surgery itself, it is also known that there is significant blood loss pre-operatively following the hip fracture event, particularly in extracapsular hip fractures. A prospective, randomized, double blinded, placebo controlled trial will elucidate the roll of early administration of TXA in a population of patients who sustain hip fractures. The study aims to investigate the hypothesis that early administration of TXA following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. There will be two treatment arms in the study. The treatment group will be given 1950mg of oral TXA (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. Those randomized to the control group will be given 3 tablets of oral placebo in the emergency department following diagnosis of hip fracture. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.
- Conditions
- Hip Fractures, Blood Loss
- Being tested
- Tranexamic Acid Pill, Placebo Oral Tablet
- Keywords
- hip fracture, blood loss, tranexamic acid
- Medical subject headings
- Hip Fractures, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid PillDrug
Patients will receive 1950mg of an oral tranexamic acid pill (3 pills total) while down in the Emergency Department after being diagnosed with a hip fracture. After they receive the oral TXA and are medically optimized, they will be taken to the operating room for fracture fixation.
Placebo Oral TabletDrug
Patients in the control arm will receive 3 placebo pills while down in the Emergency Department after being diagnosed with a hip fracture. After they receive the placebo pills and are medically optimized for surgery, they will be taken to the operating room for fracture fixation.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Treatment Group | Active comparator | The intervention for the treatment group is as follows: participants in this treatment arm will given 1950mg of oral tranexamic acid pills (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. Receives: Drug: Tranexamic Acid Pill |
| Oral Placebo Control Group | Placebo comparator | The intervention for the control group is as follows: participants in this treatment arm will given 3 tablets of oral placebo pills in the emergency department following diagnosis of hip fracture. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion rate
Preoperative, intraoperative, and postoperative blood transfusions will be considered as the primary outcome measure. This outcome will be measured in number of units of packed red blood cells administered during the participant's hospital stay.
Measured: This outcome will be recorded daily from the time of admission to the Emergency Department through the time of discharge from the hospital, assessed up to 7 days.
Hemoglobin Level
Labs, specifically a complete blood count (CBC) to evaluate a hemoglobin level (in grams per deciliter), will be drawn at the following time points: Admission to the Emergency Department, nightly (9pm) for each day of hospitalization and one hour after completion of a blood transfusion.
Measured: This outcome will be recorded daily from the time of admission to the Emergency Department to the time of discharge from the hospital, up to 7 days.
Secondary outcomes (2)
Estimated blood loss
Measured amount of blood loss recorded during the surgery. These values will be compared between the two study arms to determine if administration of oral TXA decreases the intra-operative blood loss.
Measured: Starting at time of surgical incision and will end once the surgery is completed.
Frequency of adverse events.
Documentation of any adverse events in the peri-operative period. For example, transfusion reaction, myocardial infarction, symptomatic deep vein thrombosis, pulmonary embolism, stroke, reoperation, readmission, infection, and death.
Measured: From time of admission to the Emergency department up to 12 months after the date of surgery. Outcome measure will be recorded daily while participant is hospitalized and monthly after discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study startSep 2019 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: Could not work out internal logistics
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trent Guthrie, Henry Ford Health System
- Investigators
- Trent Guthrie, MD, Principal investigator, Henry Ford Hospital Department of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05518279
- Sponsor's protocol ID
- 11411
- Status last verified
- Aug 2022
- First submitted
- 22 Jan 2019
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration Of Tranexamic Acid And Acute Blood Loss In Patients With Hip Fractures: A Prospective, Randomized, Double-blinded, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT05518279
- Acronym / sponsor ID
- 11411
- Conditions
- Hip Fractures, Blood Loss
- Keywords
- hip fracture, blood loss, tranexamic acid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not work out internal logistics
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 26 Aug 2022 (actual)
- 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.
The study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (TXA) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. Patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. The treatment group will receive 1950mg of oral TXA (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the Emergency Department. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.
Detailed description
There remains a high incidence of blood transfusion in patients following hip fractures. Tranexamic acid (TXA) has well-studied efficacy in decreasing blood loss and transfusion requirements in the context of general trauma, as well as several elective orthopaedic procedures. Although blood is lost in hip fracture surgery itself, it is also known that there is significant blood loss pre-operatively following the hip fracture event, particularly in extracapsular hip fractures. A prospective, randomized, double blinded, placebo controlled trial will elucidate the roll of early administration of TXA in a population of patients who sustain hip fractures. The study aims to investigate the hypothesis that early administration of TXA following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. There will be two treatment arms in the study. The treatment group will be given 1950mg of oral TXA (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. Those randomized to the control group will be given 3 tablets of oral placebo in the emergency department following diagnosis of hip fracture. Patients will then be admitted to the Orthopaedic Trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Treatment Group | Active comparator | Drug: Tranexamic Acid PillThe intervention for the treatment group is as follows: participants in this treatment arm will given 1950mg of oral tranexamic acid pills (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. |
| Oral Placebo Control Group | Placebo comparator | Drug: Placebo Oral TabletThe intervention for the control group is as follows: participants in this treatment arm will given 3 tablets of oral placebo pills in the emergency department following diagnosis of hip fracture. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age over 50
- Clinical diagnosis of acute femoral neck, intertrochanteric or subtrochanteric femur fracture
Key exclusion criteria (11 listed)
- anticoagulant use at time of admission to emergency department
- documented allergy to tranexamic acid
- history of deep vein thrombosis or pulmonary embolism
- hepatic dysfunction (aspartate aminotransferase (AST)/alanine aminotransferase (ALT) > 60)
- renal dysfunction (Creatinine > 1.5 or Glomerular Filtration Rate < 30)
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 PillPatients will receive 1950mg of an oral tranexamic acid pill (3 pills total) while down in the Emergency Department after being diagnosed with a hip fracture. After they receive the oral TXA and are medically optimized, they will be taken to the operating room for fracture fixation. | Drug | Tranexamic Acid Treatment Group |
| Placebo Oral TabletPatients in the control arm will receive 3 placebo pills while down in the Emergency Department after being diagnosed with a hip fracture. After they receive the placebo pills and are medically optimized for surgery, they will be taken to the operating room for fracture fixation. | Drug | Oral Placebo Control Group |
Primary outcome
Blood transfusion rate
Time frame: This outcome will be recorded daily from the time of admission to the Emergency Department through the time of discharge from the hospital, assessed up to 7 days.
Preoperative, intraoperative, and postoperative blood transfusions will be considered as the primary outcome measure. This outcome will be measured in number of units of packed red blood cells administered during the participant's hospital stay.
Hemoglobin Level
Time frame: This outcome will be recorded daily from the time of admission to the Emergency Department to the time of discharge from the hospital, up to 7 days.
Labs, specifically a complete blood count (CBC) to evaluate a hemoglobin level (in grams per deciliter), will be drawn at the following time points: Admission to the Emergency Department, nightly (9pm) for each day of hospitalization and one hour after completion of a blood transfusion.
2 secondary outcomes
Estimated blood loss
Time frame: Starting at time of surgical incision and will end once the surgery is completed.
Frequency of adverse events.
Time frame: From time of admission to the Emergency department up to 12 months after the date of surgery. Outcome measure will be recorded daily while participant is hospitalized and monthly after discharge from the hospital.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- 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.
Trent Guthrie, MD principal investigator
Henry Ford Hospital Department of Orthopaedic Surgery
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid Pill in people with Hip Fractures and Blood Loss, run by Henry Ford Health System.
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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 26 Aug 2022. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was withdrawn before enrolling participants, so there are no results.
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: This outcome will be recorded daily from the time of admission to the Emergency Department through the time of discharge from the hospital, assessed up to 7 days.). The study lists 2 primary outcomes in all. 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 26 Aug 2022.