Blood Loss, SurgicalPhase 2NCT03251469
Single Dose of Tranexamic Acid and Blood Loss, in Elderly Patients With Hip Fracture
A Phase 2 study testing Tranexamic Acid 15mg/kg , iv, Single Dose and Normal Saline, 100mg, iv, Singe dose in people with Blood Loss, Surgical and Hip Fractures, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Blood Loss, Surgical, Hip Fractures, Complication, Postoperative
- What is being tested?
- Tranexamic Acid 15mg/kg , iv, Single Dose and Normal Saline, 100mg, iv, Singe dose
- 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 siteGreece
- Study dates
- Jan 2013to Feb 2018
- Phase
- Phase 2
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Consecutive elderly patients (age >75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture.
Who cannot join
- Any contraindication for tranexamic acid
- Multiple fractures
- Requirement for anticoagulant therapy that could not be stopped.
- Ongoing thromboembolic event
- reduced kidney function
- malignancy,
Show all 9Show fewer
- pathological fracture
- previous operation on the affected hip
- Active coronary artery disease (event in the past 12 months).
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
2nd Department of Orthopaedics
Athens, Attica, 14233
Vasileios Nikolaou, MD, +306932543400, vassilios.nikolaou@gmail.com
About this study
Official title: Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery
The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).
- Being tested
- Tranexamic Acid 15mg/kg , iv, Single Dose, Normal Saline, 100mg, iv, Singe dose
- Keywords
- tranexamic acid, blood tranfusion, hip fractures, elderly, blood loss
- Medical subject headings
- Blood Loss, Surgical, Hip Fractures, Postoperative Complications, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid 15mg/kg , iv, Single DoseDrug
Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
Normal Saline, 100mg, iv, Singe doseDrug
Normal Saline, 100mg, administered intravenously, preoperatively in single dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | intravenous tranexamic acid, 15mg/kg, preoperatively, single dose Receives: Drug: Tranexamic Acid 15mg/kg , iv, Single Dose |
| Group 2 | Placebo comparator | Intravenous normal saline, 100mg, preoperatively, single dose Receives: Drug: Normal Saline, 100mg, iv, Singe dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of transfusions of allogeneic RBC from surgery up to day 4
Measured: 5 days
total blood loss from surgery to day
Measured: 5 days
Secondary outcomes (2)
incidence of vascular events
Measured: 3 months
Incidence of deaths
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2017
- Study startJan 2013
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasileios S. Nikolaou, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03251469
- Sponsor's protocol ID
- 2
- Status last verified
- Aug 2017
- First submitted
- 29 Nov 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose of Tranexamic Acid at the Time of Surgery and Blood Loss, in Elderly Patients Undergoing Hip Fracture Surgery
- ClinicalTrials.gov ID
- NCT03251469
- Acronym / sponsor ID
- 2
- Keywords
- tranexamic acid, blood tranfusion, hip fractures, elderly, blood loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 16 Aug 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.
The aim of this study is to investigate the hypothesis that single dose of tranexamic acid (TXA) preoperatively will lower blood loss and transfusion rate in elderly patients with hip fractures (intertrochanteric or Subcapital), that will be treated with intramedullary nailing and cemented hemiarthroplasty respectively. After application of inclusion and exclusion criteria, patients will be randomized in two groups. Group 1 will include patients that receive preoperatively single dose of TXA (15mg/kg) and Group 2 will include patients that receive normal saline (control group).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Tranexamic Acid 15mg/kg , iv, Single Doseintravenous tranexamic acid, 15mg/kg, preoperatively, single dose |
| Group 2 | Placebo comparator | Drug: Normal Saline, 100mg, iv, Singe doseIntravenous normal saline, 100mg, preoperatively, single dose |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Consecutive elderly patients (age >75 yo) undergoing hip fracture surgery for a stable or unstable intertrochanteric hip fracture with the insertion of a short intramedullary nail (IMN) as well as patients treated surgically with cemented hemiarthroplasty for acute femoral neck (subcapital) hip fracture.
Key exclusion criteria (9 listed)
- Any contraindication for tranexamic acid
- Multiple fractures
- Requirement for anticoagulant therapy that could not be stopped.
- Ongoing thromboembolic event
- reduced kidney function
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 15mg/kg , iv, Single DoseTranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose | Drug | Group 1 |
| Normal Saline, 100mg, iv, Singe doseNormal Saline, 100mg, administered intravenously, preoperatively in single dose | Drug | Group 2 |
Primary outcome
number of transfusions of allogeneic RBC from surgery up to day 4
Time frame: 5 days
total blood loss from surgery to day
Time frame: 5 days
2 secondary outcomes
incidence of vascular events
Time frame: 3 months
Incidence of deaths
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tranexamic Acid 15mg/kg , iv, Single Dose and Normal Saline, 100mg, iv, Singe dose in people with Blood Loss, Surgical and Hip Fractures, run by National and Kapodistrian University of Athens at 1 site in Greece.
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 9 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 16 Aug 2017. 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 Greece. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Vasileios S Nikolaou, MD (+306932543400, vassilios.nikolaou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of transfusions of allogeneic RBC from surgery up to day 4 (time frame: 5 days). The study lists 2 primary outcomes in all. 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 16 Aug 2017.