Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers SystemPhase 4TXANCT07116395
Prospective Study: TXA, Anticoagulant, Orthopaedic Trauma
A Phase 4 study testing Tranexamic Acid (TXA) in people with Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System, run by Arbi Nazarian, MD at 1 site in United States.
Trial summary
Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System
- What is being tested?
- Tranexamic Acid (TXA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 31 Dec 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Patients undergoing operative fixation of long bone fractures; Included conditions include femoral neck fractures, intertrochanteric femur fractures, femoral shaft fractures, distal femur fractures, and tibial shaft fractures that undergo surgical management
Who cannot join
- Exclusion criteria for this study will be patients under 18 and prisoners
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Community Regional Medical Center
Fresno, California, 93701
Yeng Vue, MA, 559-761-5636, Yeng.Vue@ucsf.edu
Arbi Nazarian, MD
About this study
Official title: Outcomes of Tranexamic Acid With Anticoagulants in Orthopaedic Trauma Procedures: A Prospective Study
Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased risk of thrombotic complication. Given the safety and efficacy of this medication in one subspeciality of orthopedics, it is warranted to investigate the use of it in another subspeciality where blood loss is also of concern. It is also of the utmost importance to identify medications that can safely be given to our population to not only improve patient outcomes but also decrease patient costs in the setting of significant disparities. The application of these findings to orthopedic trauma is not something that has been largely studied or appears in the literature. We hope to fill this gap of knowledge to allow for the application of a safe and beneficial medication to a much larger subset of patients than that that is already receiving the medication routinely. The use of TXA in orthopedic patients who are on anticoagulation versus those who are not is also not something that has been previously studied and another knowledge gap that we hope to fill.
- Being tested
- Tranexamic Acid (TXA)
- Keywords
- TXA, Anticoagulant, Orthopaedic Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA)Drug
orthopedic trauma patients who are on anticoagulation
| Study group | Role | What they receive |
|---|---|---|
| Yes TXA Administered | Experimental | Not described Receives: Drug: Tranexamic Acid (TXA) |
| No TXA Administered | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss (EBL) comparison between those who received TXA vs no TXA
Less estimated blood loss after surgery for patients who were administered TXA
Measured: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure
Secondary outcomes (1)
Hospital Length of Stay for Patients who received TXA vs no TXA
Patient medical records will be reviewed post-operatively and data will be collected in our study specific data sheet.
Measured: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start1 Jan 2027 (estimated)
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers SystemStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arbi Nazarian, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Inspire Health Medical Group
- Responsible party
- Sponsor-investigator, Arbi Nazarian, MD, University of California, San Francisco
- Investigators
- Arbi Nazarian, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116395
- Sponsor's protocol ID
- Nazarian_TXA_Prospective2025
- Acronym
- TXA
- Status last verified
- Aug 2026
- First submitted
- 29 Jul 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Currently, there is no plan to share IPD with other researchers as the study team does not have full approval to share data from our local collaborative hospital site.
Publications
Lin YK, Liu KT, Chen CW, Lee WC, Lin CJ, Shi L, Tien YC. How to effectively obtain informed consent in trauma patients: a systematic review. BMC Med Ethics. 2019 Jan 23;20(1):8. doi: 10.1186/s12910-019-0347-0.
PubMed 30674301Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021 Aug 11;19(1):54. doi: 10.1186/s12959-021-00303-9.
PubMed 34380507Zhang P, Liang Y, Chen P, Fang Y, He J, Wang J. Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2017 Feb 21;18(1):90. doi: 10.1186/s12891-017-1429-0.
PubMed 28222709Zhu Q, Yu C, Chen X, Xu X, Chen Y, Liu C, Lin P. Efficacy and Safety of Tranexamic Acid for Blood Salvage in Intertrochanteric Fracture Surgery: A Meta-Analysis. Clin Appl Thromb Hemost. 2018 Nov;24(8):1189-1198. doi: 10.1177/1076029618783258. Epub 2018 Jun 21.
PubMed 29929380Deng ZF, Zhang ZJ, Sheng PY, Fu M, Xu DL, He AS, Liao WM, Kang Y. Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid. Medicine (Baltimore). 2020 Sep 4;99(36):e22028. doi: 10.1097/MD.0000000000022028.
PubMed 32899057Hourlier H, Fennema P. Tranexamic acid use and risk of thrombosis in regular users ofantithrombotics undergoing primary total knee arthroplasty: a prospectivecohort study. Blood Transfus. 2018 Jan;16(1):44-52. doi: 10.2450/2016.0160-16. Epub 2016 Oct 4.
PubMed 27723454Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
PubMed 25440395
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Tranexamic Acid With Anticoagulants in Orthopaedic Trauma Procedures: A Prospective Study
- ClinicalTrials.gov ID
- NCT07116395
- Acronym / sponsor ID
- TXA / Nazarian_TXA_Prospective2025
- Keywords
- TXA, Anticoagulant, Orthopaedic Trauma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Arbi Nazarian, MDUniversity, hospital or other
- Collaborators
- Inspire Health Medical Group
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Aug 2025 (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.
Tranexamic acid, an anti-fibrinolytic agent, is commonly given after induction of general anesthesia in patients undergoing hip and knee arthroplasty. This medication has been associated with decreased blood loss during these procedures, decreased rate of blood transfusion, decreased hospital costs, and no increased risk of thrombotic complication. Given the safety and efficacy of this medication in one subspeciality of orthopedics, it is warranted to investigate the use of it in another subspeciality where blood loss is also of concern. It is also of the utmost importance to identify medications that can safely be given to our population to not only improve patient outcomes but also decrease patient costs in the setting of significant disparities. The application of these findings to orthopedic trauma is not something that has been largely studied or appears in the literature. We hope to fill this gap of knowledge to allow for the application of a safe and beneficial medication to a much larger subset of patients than that that is already receiving the medication routinely. The use of TXA in orthopedic patients who are on anticoagulation versus those who are not is also not something that has been previously studied and another knowledge gap that we hope to fill.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yes TXA Administered | Experimental | Drug: Tranexamic Acid (TXA) |
| No TXA Administered | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing operative fixation of long bone fractures; Included conditions include femoral neck fractures, intertrochanteric femur fractures, femoral shaft fractures, distal femur fractures, and tibial shaft fractures that undergo surgical management
Key exclusion criteria (1 listed)
- Exclusion criteria for this study will be patients under 18 and prisoners
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)orthopedic trauma patients who are on anticoagulation | Drug | Yes TXA Administered |
Primary outcome
Estimated blood loss (EBL) comparison between those who received TXA vs no TXA
Time frame: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure
Less estimated blood loss after surgery for patients who were administered TXA
1 secondary outcome
Hospital Length of Stay for Patients who received TXA vs no TXA
Time frame: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Background: PubMed 30674301Lin YK, Liu KT, Chen CW, Lee WC, Lin CJ, Shi L, Tien YC. How to effectively obtain informed consent in trauma patients: a systematic review. BMC Med Ethics. 2019 Jan 23;20(1):8. doi: 10.1186/s12910-019-0347-0.
- Background: PubMed 34380507Ockerman A, Vanassche T, Garip M, Vandenbriele C, Engelen MM, Martens J, Politis C, Jacobs R, Verhamme P. Tranexamic acid for the prevention and treatment of bleeding in surgery, trauma and bleeding disorders: a narrative review. Thromb J. 2021 Aug 11;19(1):54. doi: 10.1186/s12959-021-00303-9.
- Background: PubMed 28222709Zhang P, Liang Y, Chen P, Fang Y, He J, Wang J. Combined application versus topical and intravenous application of tranexamic acid following primary total hip arthroplasty: a meta-analysis. BMC Musculoskelet Disord. 2017 Feb 21;18(1):90. doi: 10.1186/s12891-017-1429-0.
- Background: PubMed 29929380Zhu Q, Yu C, Chen X, Xu X, Chen Y, Liu C, Lin P. Efficacy and Safety of Tranexamic Acid for Blood Salvage in Intertrochanteric Fracture Surgery: A Meta-Analysis. Clin Appl Thromb Hemost. 2018 Nov;24(8):1189-1198. doi: 10.1177/1076029618783258. Epub 2018 Jun 21.
- Background: PubMed 32899057Deng ZF, Zhang ZJ, Sheng PY, Fu M, Xu DL, He AS, Liao WM, Kang Y. Effect of 3 different anticoagulants on hidden blood loss during total hip arthroplasty after tranexamic acid. Medicine (Baltimore). 2020 Sep 4;99(36):e22028. doi: 10.1097/MD.0000000000022028.
- Background: PubMed 27723454Hourlier H, Fennema P. Tranexamic acid use and risk of thrombosis in regular users ofantithrombotics undergoing primary total knee arthroplasty: a prospectivecohort study. Blood Transfus. 2018 Jan;16(1):44-52. doi: 10.2450/2016.0160-16. Epub 2016 Oct 4.
- Background: PubMed 25440395Hunt BJ. The current place of tranexamic acid in the management of bleeding. Anaesthesia. 2015 Jan;70 Suppl 1:50-3, e18. doi: 10.1111/anae.12910.
- Individual participant dataSharing planned: No. Currently, there is no plan to share IPD with other researchers as the study team does not have full approval to share data from our local collaborative hospital site.
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.
Arbi Nazarian, MD principal investigator
University of California, San Francisco
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 (TXA) in people with Patients Undergoing Operative Fixation of Long Bone Fractures Within the Community Medical Centers System, run by Arbi Nazarian, MD 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 1 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: opening soon, as of the sponsor's last update on 11 Aug 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yeng Vue, MA (559-761-5636, Yeng.Vue@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (EBL) comparison between those who received TXA vs no TXA (time frame: EBL note is made post-procedure by surgical team, and research team will collect data at least one month post-procedure). 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 NCT07116395, which also lists 7 linked publications.
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 11 Aug 2026.