Hip FracturesPhase 4NCT03211286
Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients
A Phase 4 study testing Tranexamic Acid and Saline Solution in people with Hip Fractures and Anemia, run by Alejandro Lizaur-Utrilla, PhD, MD at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures, Anemia
- What is being tested?
- Tranexamic Acid and Saline Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 129 participants
- Where
- 2 sitesSpain
- Study dates
- 30 Jan 2018to 8 Mar 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- consecutive patients with a diagnosis of hip fractures treated at our hospital by any surgical procedureExclusion Criteria:
- Age over 60 years
Who cannot join
- ASA IV
- Concomitant fracture
- Refusal to receive blood products
- Preoperative anemia needing blood transfusion before surgery
- Severe comorbidity (cancer, severe pulmonary disease)
- Allergy for tranexamic acid.
Show all 16Show fewer
- History of acute thromboembolic event (Deep Vein Thrombosis, Pulmonary Embolism, Stroke)
- Coagulopathy (INR > 1.4)
- Myocardial infarction in the previous 12 months
- Coronary stents
- Renal function impairment (serum creatinine > 2 mg/dL or creatinine clearance <30 mL/min),) or kidney transplant
- Platelet antiaggregant treatment in the week before surgery.
- Severe hepatic dysfunction (AST/ALT >60)
- History of hypercoagulability
- Acquired disturbances of color vision.
- Occurrence intraoperative surgical/medical/anesthetic complications
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Elda University Hospital
Elda, Alicante, 03600
Hospital Universitario de Elda
Elda, Alicante, 03600
About this study
Official title: Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients. A Randomized, Controlled, Double-blind Study
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 lower extremity fracture care is more limited.
Read more
Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications.
The goal of this study is to assess if the use of tranexamic acid in patients with hip fractures will result in a reduction in blood losses and blood transfusion rates.
Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.
This a double blinded, placebo controlled, therapeutic trial in which the patients will be randomized to receive TXA or a placebo (saline solution). Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, and rate of thromboembolic events, and 90 day mortality.
Read the detailed description
Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture 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 a independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: 1g of intravenous tranexamic acid at the time of surgical incision.
- Control group: placebo injection (saline solution) at the time of surgical incision.
Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study.
Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty.
Blood transfusion criteria will remain consistent with hospital standards (Hb<8 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). After discharge, .....
Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). 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
- Hip Fractures, Anemia
- Being tested
- Tranexamic Acid, Saline Solution
- Keywords
- Hip fracture, Tranexamic acid, Perioperative blood loss, Blood Transfusion
- Medical subject headings
- Hip Fractures, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called Saline solution
1 g of intravenous tranexamic acid in 100 mL of saline solution
Saline SolutionDrug
saline solution 100 mL intravenous
| Study group | Role | What they receive |
|---|---|---|
| TXA group | Active comparator | Tranexamic acid, a single dose of 1 g intravenous diluted in 100 mL saline solution at the time of surgical incision Receives: Drug: Tranexamic Acid; Drug: Saline Solution |
| Control group | Placebo comparator | Saline solution, 100 mL intravenous at the time of surgical incision Receives: Drug: Saline Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood transfusion rate
Number of patients needing blood transfusion
Measured: Hospital stay, from admission to fourth day after surgery
Secondary outcomes (4)
Perioperative Blood Loss
Measurement by serial hemoglobin and hematocrit, and calculation of loss by mathematical formulas
Measured: Hospital stay, from admission to fourth day after surgery
Infection rate
surgical and medical (pneumonia, urinary tract, etc)
Measured: 90 postoperative days
Thrombotic events
Deep Venous Thrombosis, Pulmonary Embolism, Myocardial Infarction, Stroke
Measured: 90 postoperative days
Mortality
number of deaths
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 posted7 Jul 2017
- Study start30 Jan 2018
- Primary completion2 Mar 2021
- Study completion8 Mar 2022
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
- Model description
- Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty The two patient groups will include: 1) Study group treated with tranexamic acid at the time of surgical incision; 2) Control group treated with placebo injection (saline solution). 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). After discharge, ..... Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alejandro Lizaur-Utrilla, PhD, MD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alicante
- Responsible party
- Sponsor-investigator, Alejandro Lizaur-Utrilla, PhD, MD, Elda University Hospital
- Investigators
- Alejandro Lizaur-Utrilla, PHD, MD, Study chair, Orthopaedic Surgery Department, Elda University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211286
- Sponsor's protocol ID
- TXA-Hip July2017
- Status last verified
- Apr 2022
- First submitted
- 5 Jul 2017
- Last updated
- 7 Apr 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Tranexamic Acid on Reduction of Blood Losses in Hip Fracture Patients. A Randomized, Controlled, Double-blind Study
- ClinicalTrials.gov ID
- NCT03211286
- Acronym / sponsor ID
- TXA-Hip July2017
- Conditions
- Hip Fractures, Anemia
- Keywords
- Hip fracture, Tranexamic acid, Perioperative blood loss, Blood Transfusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Alejandro Lizaur-Utrilla, PhD, MDUniversity, hospital or other
- Collaborators
- University of Alicante
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 2 Mar 2021 (actual)
- Study completion
- 8 Mar 2022 (actual)
- First posted
- 7 Jul 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.
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 lower extremity fracture care is more limited.
Hip fractures represent a common orthopedic injury in a fragile patient population that often necessitates post-operative blood transfusion thereby putting the patient at additional risk of complications.
The goal of this study is to assess if the use of tranexamic acid in patients with hip fractures will result in a reduction in blood losses and blood transfusion rates.
Our hypothesis is that by providing intravenous TXA at the time of surgery will decrease the amount of preoperative and intraoperative bleeding thereby leading to a decreased need for postoperative transfusion.
This a double blinded, placebo controlled, therapeutic trial in which the patients will be randomized to receive TXA or a placebo (saline solution). Treatment will be administered pre-operatively as well as at the time of surgical incision. The primary outcome will be need for blood transfusion. Secondary outcomes will include calculated perioperative blood loss, length of stay, and rate of thromboembolic events, and 90 day mortality.
Detailed description
Candidates for the study will be consecutive patients with a diagnosis of hip fractures treated at our center. All patients with hip fracture 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 a independent staff using computer generated randomization and allocation concealment. The two patient groups will include:
- Study group: 1g of intravenous tranexamic acid at the time of surgical incision.
- Control group: placebo injection (saline solution) at the time of surgical incision.
Both patients and the treating surgeons will be blinded with regard to placebo vs. treatment until completion of the study.
Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty.
Blood transfusion criteria will remain consistent with hospital standards (Hb<8 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). After discharge, .....
Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be treated surgically with a long trochanteric femoral nail (TFN) or hemiarthroplasty The two patient groups will include: 1) Study group treated with tranexamic acid at the time of surgical incision; 2) Control group treated with placebo injection (saline solution). 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). After discharge, ..... Patients will be followed at regular intervals (1mo, 3mo, and at least 6mo) and at each time point the patient will be asked to report any adverse events (DVT, PT, Stroke, myocardial infarction, infection, hospitalization). 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.
| Arm | Type | Receives |
|---|---|---|
| TXA group | Active comparator | Drug: Tranexamic Acid, Drug: Saline SolutionTranexamic acid, a single dose of 1 g intravenous diluted in 100 mL saline solution at the time of surgical incision |
| Control group | Placebo comparator | Drug: Saline SolutionSaline solution, 100 mL intravenous at the time of surgical incision |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- consecutive patients with a diagnosis of hip fractures treated at our hospital by any surgical procedureExclusion Criteria:
- Age over 60 years
Key exclusion criteria (16 listed)
- ASA IV
- Concomitant fracture
- Refusal to receive blood products
- Preoperative anemia needing blood transfusion before surgery
- Severe comorbidity (cancer, severe pulmonary disease)
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 AcidAlso: Saline solution1 g of intravenous tranexamic acid in 100 mL of saline solution | Drug | TXA group |
| Saline Solutionsaline solution 100 mL intravenous | Drug | Control group, TXA group |
Primary outcome
blood transfusion rate
Time frame: Hospital stay, from admission to fourth day after surgery
Number of patients needing blood transfusion
4 secondary outcomes
Perioperative Blood Loss
Time frame: Hospital stay, from admission to fourth day after surgery
Infection rate
Time frame: 90 postoperative days
Thrombotic events
Time frame: 90 postoperative days
Mortality
Time frame: 90 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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, PHD, MD study chair
Orthopaedic Surgery Department, Elda University Hospital
2 sites 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 and Saline Solution in people with Hip Fractures and Anemia, run by Alejandro Lizaur-Utrilla, PhD, MD at 2 sites 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 16 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 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Hospital stay, from admission to fourth day after surgery). 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 7 Apr 2022.