Hip FracturesPhase 4NCT05489185
Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Hip Fracture Patients.
A Phase 4 study testing Tranexamic acid and Physiologic saline in people with Hip Fractures, run by Biogipuzkoa Health Research Institute at 1 site in Spain.
Trial summary
Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Tranexamic acid and Physiologic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 644 participants
- Where
- 1 siteSpain
- Study dates
- 30 May 2023to 1 Jun 2025
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture
- Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).
Who cannot join
- Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
- The refusal of the patient or their relatives/legal representative to participate in the study.
- Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients).
- Patients with a history of seizures.
- Patients with severe renal and hepatic insufficiency.
- Patients with venous thrombosis.
- Patients with active concomitant bleeding of renal origin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Randomized, Double-blind Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Patients With Hip Fracture"
Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality.
Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis.
It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
Read the detailed description
Prevention and treatment of bleeding due to general or local fibrinolysis
- Conditions
- Hip Fractures
- Being tested
- Tranexamic acid, Physiologic saline
- 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 acidDrug
Intravenous or topical administration
Physiologic salineOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Extracapsular fracture with intravenous contraindication (control). | Placebo comparator | Physiological saline Receives: Other: Physiologic saline |
| Extracapsular fracture with intravenous contraindication (experimental). | Experimental | Amchafibrin Receives: Drug: Tranexamic acid |
| Extracapsular fracture without intravenous contraindication (control). | Placebo comparator | Physiological saline Receives: Other: Physiologic saline |
| Extracapsular fracture without intravenous contraindication (experimental). | Experimental | Amchafibrin Receives: Drug: Tranexamic acid |
| Intracapsular fracture with intravenous contraindication (control). | Placebo comparator | Physiological saline Receives: Other: Physiologic saline |
| Intracapsular fracture with intravenous contraindication (experimental). | Experimental | Amchafibrin Receives: Drug: Tranexamic acid |
| Intracapsular fracture without intravenous contraindication (control). | Active comparator | Physiological saline Receives: Other: Physiologic saline |
| Intracapsular fracture without intravenous contraindication (experimental). | Experimental | Amchafibrin Receives: Drug: Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood transfusion
Transfusion rate from patient admission to hospital discharge.
Measured: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Secondary outcomes (3)
Total blood loss
Measured: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Adverse events
Measured: 3,6,9 and 12 months
Days at hospital
Measured: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2022
- Study start30 May 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 644 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biogipuzkoa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05489185
- Sponsor's protocol ID
- 2020_TRANEXAMICO
- Status last verified
- Aug 2022
- First submitted
- 1 Aug 2022
- Last updated
- 17 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Randomized, Double-blind Clinical Trial to Assess the Efficacy of Tranexamic Acid in Reducing Blood Loss in Patients With Hip Fracture"
- ClinicalTrials.gov ID
- NCT05489185
- Acronym / sponsor ID
- 2020_TRANEXAMICO
- Conditions
- Hip Fractures
- Keywords
- Hip Fracture, Blood loss, tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 644 participants (estimated)
- Lead sponsor
- Biogipuzkoa Health Research InstituteUniversity, hospital or other
- Study start
- 30 May 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 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.
Hip fracture in elderly patients is a pathology with a high economic and health impact on the patient himself and on the National Health System, especially considering the significant aging of the population of the Basque Country. Despite advances, hip fracture remains in the clinical groups with the highest in-hospital mortality. Hip fracture is associated with numerous adverse events and high mortality.
Numerous antifibrinolytics, such as tranexamic acid (TXA), have been used to limit bleeding in orthopedic surgery and thus prevent the need for blood transfusion. Numerous studies have shown that the use of tranexamic acid does not increase the risk of thrombosis.
It is proposed to carry out clinical research with drugs without commercial interest. A randomized, double-blind clinical trial to assess the efficacy of tranexamic acid in reducing blood loss in elderly patients with hip fracture.
Detailed description
Prevention and treatment of bleeding due to general or local fibrinolysis
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Extracapsular fracture with intravenous contraindication (control). | Placebo comparator | Other: Physiologic salinePhysiological saline |
| Extracapsular fracture with intravenous contraindication (experimental). | Experimental | Drug: Tranexamic acidAmchafibrin |
| Extracapsular fracture without intravenous contraindication (control). | Placebo comparator | Other: Physiologic salinePhysiological saline |
| Extracapsular fracture without intravenous contraindication (experimental). | Experimental | Drug: Tranexamic acidAmchafibrin |
| Intracapsular fracture with intravenous contraindication (control). | Placebo comparator | Other: Physiologic salinePhysiological saline |
| Intracapsular fracture with intravenous contraindication (experimental). | Experimental | Drug: Tranexamic acidAmchafibrin |
| Intracapsular fracture without intravenous contraindication (control). | Active comparator | Other: Physiologic salinePhysiological saline |
| Intracapsular fracture without intravenous contraindication (experimental). | Experimental | Drug: Tranexamic acidAmchafibrin |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patients over or equal to 65 years of age, of both sexes, who are going to be operated on for a hip fracture
- Accept participation in the study (informed consent that will be signed by the patient or family member/legal representative depending on the patient's degree of autonomy).
Key exclusion criteria (7 listed)
- Under treatment with another experimental drug (who is not participating in another clinical trial with an experimental drug).
- The refusal of the patient or their relatives/legal representative to participate in the study.
- Known allergy to TXA ( Hipersensivity to TXA o to any of the excipients).
- Patients with a history of seizures.
- Patients with severe renal and hepatic insufficiency.
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 acidIntravenous or topical administration | Drug | Extracapsular fracture with intravenous contraindication (experimental)., Extracapsular fracture without intravenous contraindication (experimental)., Intracapsular fracture with intravenous contraindication (experimental)., Intracapsular fracture without intravenous contraindication (experimental). |
| Physiologic salinePlacebo | Other | Extracapsular fracture with intravenous contraindication (control)., Extracapsular fracture without intravenous contraindication (control)., Intracapsular fracture with intravenous contraindication (control)., Intracapsular fracture without intravenous contraindication (control). |
Primary outcome
Blood transfusion
Time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Transfusion rate from patient admission to hospital discharge.
3 secondary outcomes
Total blood loss
Time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Adverse events
Time frame: 3,6,9 and 12 months
Days at hospital
Time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Physiologic saline in people with Hip Fractures, run by Biogipuzkoa Health Research Institute 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 7 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 17 May 2023. 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. 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?
Results are not available in the source record.
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 (time frame: From date of randomization until the date of hospital discharge, it is estimated to be day 3 post - operation.). 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 17 May 2023.