AmyloidosisAPTURNCT06527521
Prevalence of Amyloidosis in Trauma Patients
An observational study of Amyloidosis, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amyloidosis
- What is being tested?
- Traumatologic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 246 participants
- Where
- 1 siteSpain
- Study dates
- 13 Nov 2024to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients included in the waiting list for scheduled trauma surgery
Who may be able to join
- Men and women included in the waiting list for scheduled trauma surgery with at least one of the following criteria defined as red flags: Over 65 years old; Possible family history of amyloidosis, Cardiac pathology: aortic stenosis, presence of left ventricular hypertrophy defined as interventricular septal thickness > 12mm measured by echocardiography, history of previous brady- or tachyarrhythmias including cardiac conduction blocks, history of syncope or presyncope, pro BNP > 300 in previous blood tests; History of sensory peripheral neuropathy; History of nephropathy without etiological diagnosis; History of liver disease without a clear cause.
- Ability to cooperate in the necessary evaluations.
- Signed informed consent for inclusion in the study, either by the participant or their legal representative.
Who cannot join
- Participants previously diagnosed with amyloidosis cannot be included in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil
Sant Pere de Ribes, Barcelona, 08810
Lidia Tikhomirova, +34 938960025, ltikhomirova@csapg.cat
Noemí Casaponsa, +34 938960025 ext. 43197, recerca@csapg.cat
About this study
Official title: Prevalence of Amyloidosis in Trauma Patients Using Red Flags Tool
This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.
- Conditions
- Amyloidosis
- Being tested
- Traumatologic surgery
- Keywords
- Amyloidosis, Red Flags tool, Traumatology
- Medical subject headings
- Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traumatologic surgeryProcedure or surgery
Patients undergoing trauma surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Amyloidosis
Proportion of patients undergoing scheduled orthopedic surgery who are diagnosed with amyloidosis.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start13 Nov 2024
- Primary completionAug 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmyloidosisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 246 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lidia Tikhomirova, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527521
- Sponsor's protocol ID
- CSAPG-61
- Acronym
- APTUR
- Status last verified
- Oct 2026
- First submitted
- 25 Jul 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Amyloidosis in Trauma Patients Using Red Flags Tool
- ClinicalTrials.gov ID
- NCT06527521
- Acronym / sponsor ID
- APTUR / CSAPG-61
- Conditions
- Amyloidosis
- Keywords
- Amyloidosis, Red Flags tool, Traumatology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 246 participants (estimated)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 30 Jul 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 aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients included in the waiting list for scheduled trauma surgery
Key inclusion criteria (3 listed)
- Men and women included in the waiting list for scheduled trauma surgery with at least one of the following criteria defined as red flags: Over 65 years old; Possible family history of amyloidosis, Cardiac pathology: aortic stenosis, presence of left ventricular hypertrophy defined as interventricular septal thickness > 12mm measured by echocardiography, history of previous brady- or tachyarrhythmias including cardiac conduction blocks, history of syncope or presyncope, pro BNP > 300 in previous blood tests; History of sensory peripheral neuropathy; History of nephropathy without etiological diagnosis; History of liver disease without a clear cause.
- Ability to cooperate in the necessary evaluations.
- Signed informed consent for inclusion in the study, either by the participant or their legal representative.
Key exclusion criteria (1 listed)
- Participants previously diagnosed with amyloidosis cannot be included in the study.
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 |
|---|---|---|
| Traumatologic surgeryPatients undergoing trauma surgery | Procedure or surgery | – |
Primary outcome
Amyloidosis
Time frame: One month
Proportion of patients undergoing scheduled orthopedic surgery who are diagnosed with amyloidosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Related trials for Amyloidosis
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
Active, not recruitingPhase 2
A Study to Evaluate the Safety and Biomarker Effects of RO7269162 in Participants at Risk for or at the Prodromal Stage of Alzheimer's Disease (AD)
Alzheimer's Disease
Active, not recruitingObservational study
A Retrospective Observational Study of Epidemiology and Outcomes in Transthyretin Amyloid Cardiomyopathy in Germany
ATTR-CM (Transthyretin Amyloid Cardiomyopathy)
Active, not recruitingPhase 3
EPIC-ATTR: A Study to Evaluate the Effect of Eplontersen on the Transthyretin Reduction and Long-term Safety in Chinese Subjects With Transthyretin Amyloid Cardiomyopathy
Transthyretin Amyloid Cardiomyopathy
RecruitingObservational study
PET Imaging in the Baltimore Longitudinal Study of Aging (BLSA)
Aging
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.
Lidia Tikhomirova, MD principal investigator
CSAPG
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 Amyloidosis, run by Consorci Sanitari de l'Alt Penedès i Garraf 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 3 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lidia Tikhomirova, MD (+34 938960025, ltikhomirova@csapg.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amyloidosis (time frame: One month). 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 27 Oct 2026.