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RecruitingNCT06527521APTURUpdated Dec 2, 2025

Prevalence of Amyloidosis in Trauma Patients

An observational study in Amyloidosis, sponsored by Consorci Sanitari de l'Alt Penedès i Garraf. Recruiting at 1 site in Spain. Per ClinicalTrials.gov, last updated 2025-12-02.

Sponsored by Consorci Sanitari de l'Alt Penedès i Garraf · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
246
Sex
All
01

Study summary

This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.

02

Conditions studied

  • Amyloidosis

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Keywords

  • Amyloidosis
  • Red Flags tool
  • Traumatology
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients included in the waiting list for scheduled trauma surgery

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

- Participants previously diagnosed with amyloidosis cannot be included in the study.

04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
246 participants (estimated)
Patient registry
No

Interventions

  • ProcedureTraumatologic surgery

    Patients undergoing trauma surgery

05

What researchers measure

Primary outcomes

  1. Amyloidosis

    Proportion of patients undergoing scheduled orthopedic surgery who are diagnosed with amyloidosis.

    Time frame: One month

06

Study locations

1 of 1 sites recruiting
  • Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil
    Sant Pere de Ribes, Barcelona 08810, Spain
    Recruiting
07

References and documents

Individual participant data

Plan to share: 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).

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06527521
Lead sponsor
Consorci Sanitari de l'Alt Penedès i Garraf
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
Nov 13, 2024
Primary completion
Aug 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Dec 2, 2025

Study contacts

Lidia Tikhomirova, MD
Contact
ltikhomirova@csapg.cat
+34 938960025
Noemí Casaponsa
Contact
recerca@csapg.cat
+34 938960025 ext. 43197
Lidia Tikhomirova, MD
principal investigator · CSAPG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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