Metastases to BoneNCT06244498
Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty
An observational study of Metastases to Bone, run by Piotr Biega at 1 site in Poland.
Trial summary
This study assesses the safety and efficacy of TXA for patients treated for pathological femur fractures using modular prosthetics. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metastases to Bone
- What is being tested?
- Tranexamic acid injection
- Type of treatment
- Injection or infusion
- How many people
- 110 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Investigetor analysed a group of paticipants who underwent surgery for metastatic tumours of the proximal femur using modular prostheses between 2017 and 2021.
Who may be able to join
- Patological fracture
- Arthroplasty using a modular prosthesis.
Who cannot join
- threatened fracture
- intraoperative blood transfusion
- fracture fixation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty: Retrospective Observational Study
This study assesses the safety and efficacy of TXA for patients treated for pathological femur fractures using modular prosthetics.
Read the detailed description
Tranexamic acid is an efficacious medication for curtailing blood loss, haemoglobin drop, and the requirement for transfusions. Additionally, it is a secure medication, even when administered to oncology patients receiving reduction haemarthroplasty for pathological femoral fractures.
- Conditions
- Metastases to Bone
- Being tested
- Tranexamic acid injection
- Keywords
- Blood Transfusion, Neoplasm Metastasis, Bone
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid injectionDrug
Tranexamic acid were administered at a dose of 1.0 g during the induction of anaesthesia and immediately after surgery.
| Study group | Role | What they receive |
|---|---|---|
| TXA | Tranexamic acid was administered to the participants at a dose of 1.0 g during the induction of anaesthesia and immediately after the operation. Receives: Drug: Tranexamic acid injection | |
| Non-TXA | Tranexamic acid were not administred to the participants . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who require a blood transfusion.
Need of blood transfusion
Measured: During Hospitalization (up to day 10)
Secondary outcomes (2)
Estimeted blood lost after surgery.
Gross total blood loss was estimated utilizing the formula PBV × (Hctpre- Hctpost)/Hcta
Measured: During Hospitalization (up to day 3)
Number of participants with embolic complication.
Yes or No
Measured: During Hospitalization (up to day 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start1 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastases to BoneStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piotr Biega
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Piotr Biega, Podkarpackie Oncological Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244498
- Sponsor's protocol ID
- 01
- Status last verified
- Feb 2024
- First submitted
- 12 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The datasets used and/or analysed during the current study are available from the corresponding investigator on reasonable request.
Publications
CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
PubMed 21439633Biega P, Guzik G. Tranexamic Acid Reduces Transfusion Rates After Modular Hemiarthroplasty for Pathological Femoral Fractures: A Retrospective Study. Adv Orthop. 2025 Oct 30;2025:3173784. doi: 10.1155/aort/3173784. eCollection 2025.
PubMed 41180854
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid After Pathological Fracture Treated With Modular Arthroplasty: Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT06244498
- Acronym / sponsor ID
- 01
- Conditions
- Metastases to Bone
- Keywords
- Blood Transfusion, Neoplasm Metastasis, Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Piotr BiegaUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 6 Feb 2024 (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.
This study assesses the safety and efficacy of TXA for patients treated for pathological femur fractures using modular prosthetics.
Detailed description
Tranexamic acid is an efficacious medication for curtailing blood loss, haemoglobin drop, and the requirement for transfusions. Additionally, it is a secure medication, even when administered to oncology patients receiving reduction haemarthroplasty for pathological femoral fractures.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA | – | Drug: Tranexamic acid injectionTranexamic acid was administered to the participants at a dose of 1.0 g during the induction of anaesthesia and immediately after the operation. |
| Non-TXA | – | –Tranexamic acid were not administred to the participants . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Investigetor analysed a group of paticipants who underwent surgery for metastatic tumours of the proximal femur using modular prostheses between 2017 and 2021.
Key inclusion criteria (2 listed)
- Patological fracture
- Arthroplasty using a modular prosthesis.
Key exclusion criteria (3 listed)
- threatened fracture
- intraoperative blood transfusion
- fracture fixation
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 injectionTranexamic acid were administered at a dose of 1.0 g during the induction of anaesthesia and immediately after surgery. | Drug | TXA |
Primary outcome
Number of participants who require a blood transfusion.
Time frame: During Hospitalization (up to day 10)
Need of blood transfusion
2 secondary outcomes
Estimeted blood lost after surgery.
Time frame: During Hospitalization (up to day 3)
Number of participants with embolic complication.
Time frame: During Hospitalization (up to day 10)
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 6 Feb 2024.
- Results publication: PubMed 21439633CRASH-2 collaborators; Roberts I, Shakur H, Afolabi A, Brohi K, Coats T, Dewan Y, Gando S, Guyatt G, Hunt BJ, Morales C, Perel P, Prieto-Merino D, Woolley T. The importance of early treatment with tranexamic acid in bleeding trauma patients: an exploratory analysis of the CRASH-2 randomised controlled trial. Lancet. 2011 Mar 26;377(9771):1096-101, 1101.e1-2. doi: 10.1016/S0140-6736(11)60278-X.
- Derived from this study: PubMed 41180854Biega P, Guzik G. Tranexamic Acid Reduces Transfusion Rates After Modular Hemiarthroplasty for Pathological Femoral Fractures: A Retrospective Study. Adv Orthop. 2025 Oct 30;2025:3173784. doi: 10.1155/aort/3173784. eCollection 2025.
- Individual participant dataSharing planned: Undecided. The datasets used and/or analysed during the current study are available from the corresponding investigator on reasonable request.
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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?
An observational study of Metastases to Bone, run by Piotr Biega at 1 site in Poland.
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 3 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 6 Feb 2024. 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 Poland. 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.
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?
Number of participants who require a blood transfusion. (time frame: During Hospitalization (up to day 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06244498, which also lists 2 linked publications.
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 6 Feb 2024.