Hip FracturesPhase 4NCT03063892
Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion
A Phase 4 study testing Tranexamic Acid (TXA) and Saline solution in people with Hip Fractures, run by Gregory M Georgiadis MD at 1 site in United States.
Trial summary
Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Tranexamic Acid (TXA) and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2017to 1 Sep 2027
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over the age of 60 years
- Hip fracture requiring surgical intervention
- Signs consent and agrees to participate
Who cannot join
- Under the age of 60
- Does not sign consent or refuses participation
- Known hypersensitivity to tranexamic acid
- Multiple acute fractures
- Creatinine clearance <30
- History of seizures
Show all 14Show fewer
- Active hormone therapy
- History of coagulation abnormality
- History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last year or history or recurrent DVT/PE
- Myocardial infarction (MI) and/or stents within the past year
- History of intracranial hemorrhage
- Acquired defective color vision
- Patients admitted directly to nursing units or surgery without stay in the Emergency Center
- Patients who sustain fracture while hospitalized at ProMedica Toledo Hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients
Tranexamic Acid (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.
- Conditions
- Hip Fractures
- Being tested
- Tranexamic Acid (TXA), Saline solution
- 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
Tranexamic acid is an antifibrinolytic used to control bleeding
Saline solutionDrug
Also called normal saline
Saline solution is used as the placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Placebo comparator | Will receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later. Receives: Drug: Saline solution |
| Experimental Arm | Experimental | Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later. Receives: Drug: Tranexamic Acid (TXA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients requiring packed Red Blood Cell transfusion
units, perioperative
Measured: 72 hours
Secondary outcomes (2)
intraoperative blood loss
mL
Measured: 24 hours
postoperative anemia
Hgb <7g/dL
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start30 Aug 2017
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gregory M Georgiadis MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gregory M Georgiadis MD, ProMedica Health System
- Investigators
- Gregory M Georgiadis, MD, Principal investigator, ProMedica Toledo Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063892
- Sponsor's protocol ID
- GG082015
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2015
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Tranexamic Acid (TXA) on Reduction of Postoperative Blood Transfusion in Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT03063892
- Acronym / sponsor ID
- GG082015
- Conditions
- Hip Fractures
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gregory M Georgiadis MDUniversity, hospital or other
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Feb 2017 (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 (TXA) is an antifibrolytic medication used in total hip and knee arthroplasty to reduce the need for intraoperative and postoperative blood transfusions. Limited research is available on its use in hip fracture patients. We hypothesize that the use of TXA preoperatively, perioperatively, and postoperatively will decrease blood loss and need for blood transfusion postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Placebo comparator | Drug: Saline solutionWill receive intravenous Saline solution placebo bolus dose in the Emergency Center over 10 minutes. The subject will also receive intravenous Saline solution over 8 hours prior to surgery. Another dose will be administered at the time of incision and the final dose three hours later. |
| Experimental Arm | Experimental | Drug: Tranexamic Acid (TXA)Will receive intravenous Tranexamic Acid (TXA) 15mg/kg (maximum 1 gram) bolus dose over 10 minutes in the Emergency Center. The subject will also receive an intravenous dose of Tranexamic Acid (TXA) 15mg/kg over 8 hours prior to surgery. Another 15mg/kg dose of Tranexamic Acid (TXA) will be administered over 10 minutes at the time of incision and the final dose (15mg/kg) of Tranexamic Acid (TXA) intravenously over 10 minutes three hours later. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over the age of 60 years
- Hip fracture requiring surgical intervention
- Signs consent and agrees to participate
Key exclusion criteria (14 listed)
- Under the age of 60
- Does not sign consent or refuses participation
- Known hypersensitivity to tranexamic acid
- Multiple acute fractures
- Creatinine clearance <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 (TXA)Also: CyklokapronTranexamic acid is an antifibrinolytic used to control bleeding | Drug | Experimental Arm |
| Saline solutionAlso: normal salineSaline solution is used as the placebo comparator | Drug | Control Arm |
Primary outcome
proportion of patients requiring packed Red Blood Cell transfusion
Time frame: 72 hours
units, perioperative
2 secondary outcomes
intraoperative blood loss
Time frame: 24 hours
postoperative anemia
Time frame: 72 hours
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 9 Jul 2026.
- 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.
Gregory M Georgiadis, MD principal investigator
ProMedica Toledo Hospital
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) and Saline solution in people with Hip Fractures, run by Gregory M Georgiadis 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 3 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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. 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?
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?
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?
proportion of patients requiring packed Red Blood Cell transfusion (time frame: 72 hours). 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 9 Jul 2026.