Proximal Humeral FracturePhase 4NCT05437822
Tranexamic Acid in Proximal Humeral Fractures
A Phase 4 study testing Tranexamic acid in people with Proximal Humeral Fracture and Surgical Treatment, run by Elda University Hospital at 1 site in Spain.
Trial summary
The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proximal Humeral Fracture, Surgical Treatment
- What is being tested?
- Tranexamic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 29 Jun 2022to 24 Jun 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute proximal humeral fracture
- Age over 18 years
Who cannot join
- ASA IV
- Concomitant fracture
- Refusal to receive blood products
- Allergy for tranexamic acid
- Severe hepatic dysfunction (AST/ALT >60)
- Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant
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- Active acute thromboembolic event in the past 12 months (Deep Vein Thrombosis, Pulmonary)
- Active coronary artery disease or cerebrovascular accident (event in the past 12 months).
- Coronary stents
- History of hypercoagulability
- Coagulopathy (INR > 1.4)
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Elda University Hospital
Elda, Alicante, 03600
Alejandro Lizaur-Utrilla, PhD, MD, +34 966989019, lizaur1@telefonica.net
Alejandro Lizaur-Utrilla, PhD, MD
About this study
Official title: Effect of Tranexamic Acid in Proximal Humeral Fracture Surgery. A Randomized Controlled Trial
The purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches.
This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss.
This study presents only minimal risks for the included patients.
Read the detailed description
Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality.
Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in shoulder fractures is more limited. Proximal humeral fractures represent a common orthopedic injury in elderly patients The goal of this study is to assess if the use of topic tranexamic acid in patients with proximal humeral fractures will result in a reduction in blood losses and blood transfusion rates.
The hypothesis is that by providing topic TXA at the end of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.
This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss. Secondary outcomes, need for blood transfusion, length of stay, and rate of thromboembolic events.
Candidates for the study will be consecutive patients with a diagnosis of proximal humeral fracture. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: 2 g of tranexamic acid topically infused in shoulder joint before surgical closure.
- Control group: no intervention Both patient groups will be blinded with regard to drug intervention. Patients will be treated surgically with internal fixation or arthroplasty. Blood transfusion criteria will remain consistent with hospital standards (Hb<7 g/dL or >9 g/dL if symptomatic anemia). Total number of blood transfusions received will be documented upon patient discharge.
Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery).
Patients will be followed 30 days. Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use.
- Conditions
- Proximal Humeral Fracture, Surgical Treatment
- Being tested
- Tranexamic acid
- Keywords
- proximal humeral fracture, surgical treatment, Tranexamic acid
- Medical subject headings
- Shoulder Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
2 g of tranexamic acid in 50 mL of saline
| Study group | Role | What they receive |
|---|---|---|
| TXA group | Experimental | Tranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint Receives: Drug: Tranexamic acid |
| Control group | No intervention | In the control group will not be administered TXA or any other drugs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative blood loss
Measurement of loss (in mL), calculated with mathematical formulas proposed by Nadler and Good
Measured: Hospital stay, from admission to third postoperative day.
Secondary outcomes (3)
Blood transfusion rate
Number of patients needing blood transfusion
Measured: Hospital stay, from admission to third postoperative day
Infection rate
Number of patients with surgical or medical infections (wound, pneumonia, urinary tract)
Measured: 90 postoperative days
Thrombotic event rate
Number of patients with postoperative thrombotic event (Deep Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Stroke)
Measured: 90 postoperative days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start29 Jun 2022
- Primary completion21 Jun 2023 (estimated)
- Study completion24 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proximal Humeral FractureStudies 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
- All patients will be treated surgically with an internal fixation or arthroplasty. The two patient groups will include: 1) Study group treated with topic tranexamic acid infused in shoulder joint; 2) Control group with no drug treatment. Blood transfusion criteria will remain consistent with hospital standards. Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). Patients will be followed 30 days
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elda University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Responsible party
- Principal investigator, Alejandro Lizaur-Utrilla, PhD, MD, Elda University Hospital
- Investigators
- Alejandro Lizaur Utrilla, MD, Principal investigator, Orthopaedic Surgery Department, Elda University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437822
- Sponsor's protocol ID
- TXA-Humeral Fracture
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tranexamic Acid in Proximal Humeral Fracture Surgery. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05437822
- Acronym / sponsor ID
- TXA-Humeral Fracture
- Conditions
- Proximal Humeral Fracture, Surgical Treatment
- Keywords
- proximal humeral fracture, surgical treatment, Tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Elda University HospitalUniversity, hospital or other
- Collaborators
- Universidad Miguel Hernandez de Elche
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 21 Jun 2023 (estimated)
- Study completion
- 24 Jun 2023 (estimated)
- First posted
- 29 Jun 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 purpose of this study is to determine the effect of tranexamic acid (on blood loss and transfusion requirements in patients with proximal humeral fractures requiring open surgical approaches.
This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss.
This study presents only minimal risks for the included patients.
Detailed description
Studies have shown that hip fractures have a significant perioperative blood loss. Postoperative anaemia is associated with a higher morbidity and mortality.
Tranexamic acid is a safe and effective antifibrinolytic widely used to reduce blood loss in other forms of orthopaedic surgery and in traumatized patients. However, evidence on the effectiveness of TXA in shoulder fractures is more limited. Proximal humeral fractures represent a common orthopedic injury in elderly patients The goal of this study is to assess if the use of topic tranexamic acid in patients with proximal humeral fractures will result in a reduction in blood losses and blood transfusion rates.
The hypothesis is that by providing topic TXA at the end of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.
This a blinded, controlled, therapeutic trial in which the patients will be randomized to receive TXA or no drug intervention. The primary outcome is the estimated total blood loss. Secondary outcomes, need for blood transfusion, length of stay, and rate of thromboembolic events.
Candidates for the study will be consecutive patients with a diagnosis of proximal humeral fracture. All patients meeting inclusion criteria will be recruited for enrollment into the study. Informed consent will be obtained from the patient prior to randomization.
At that time, each patient will be randomized into one of two groups by an independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: 2 g of tranexamic acid topically infused in shoulder joint before surgical closure.
- Control group: no intervention Both patient groups will be blinded with regard to drug intervention. Patients will be treated surgically with internal fixation or arthroplasty. Blood transfusion criteria will remain consistent with hospital standards (Hb<7 g/dL or >9 g/dL if symptomatic anemia). Total number of blood transfusions received will be documented upon patient discharge.
Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery).
Patients will be followed 30 days. Diagnostic studies to assess for thromboembolic events (i.e. DVT, pulmonary embolism (PE), and stroke) will be ordered only if the patient develops clinical signs or symptoms that justify their use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All patients will be treated surgically with an internal fixation or arthroplasty. The two patient groups will include: 1) Study group treated with topic tranexamic acid infused in shoulder joint; 2) Control group with no drug treatment. Blood transfusion criteria will remain consistent with hospital standards. Deep vein thrombosis (DVT) prophylaxis will remain consistent with hospital standards (subcutaneous heparin from admission until 12 hours prior to surgery and beginning 6 hours after surgery). Patients will be followed 30 days
| Arm | Type | Receives |
|---|---|---|
| TXA group | Experimental | Drug: Tranexamic acidTranexamic acid, a topic dose of 2 g diluted in 50 mL saline solution infused in shoulder joint |
| Control group | No intervention | –In the control group will not be administered TXA or any other drugs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute proximal humeral fracture
- Age over 18 years
Key exclusion criteria (11 listed)
- ASA IV
- Concomitant fracture
- Refusal to receive blood products
- Allergy for tranexamic acid
- Severe hepatic dysfunction (AST/ALT >60)
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 acid2 g of tranexamic acid in 50 mL of saline | Drug | TXA group |
Primary outcome
Perioperative blood loss
Time frame: Hospital stay, from admission to third postoperative day.
Measurement of loss (in mL), calculated with mathematical formulas proposed by Nadler and Good
3 secondary outcomes
Blood transfusion rate
Time frame: Hospital stay, from admission to third postoperative day
Infection rate
Time frame: 90 postoperative days
Thrombotic event rate
Time frame: 90 postoperative days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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.
Alejandro Lizaur Utrilla, MD principal investigator
Orthopaedic Surgery Department, Elda University 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 in people with Proximal Humeral Fracture and Surgical Treatment, run by Elda University Hospital at 1 site in Spain.
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: status not confirmed, as of the sponsor's last update on 5 Jul 2022. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alejandro Lizaur-Utrilla, MD (+34 966989019, lizaur1@telefonica.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative blood loss (time frame: Hospital stay, from admission to third postoperative day.). 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 5 Jul 2022.