Prevalence of Amyloidosis in Trauma Patients
APTUR
1 other identifier
observational
246
1 country
1
Brief Summary
This study aims to determine the frequency of amyloidosis among patients undergoing trauma surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2024
CompletedFirst Posted
Study publicly available on registry
July 30, 2024
CompletedStudy Start
First participant enrolled
November 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
December 2, 2025
December 1, 2025
1.7 years
July 25, 2024
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Amyloidosis
Proportion of patients undergoing scheduled orthopedic surgery who are diagnosed with amyloidosis.
One month
Interventions
Patients undergoing trauma surgery
Eligibility Criteria
Patients included in the waiting list for scheduled trauma surgery
You may qualify if:
- 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.
You may not qualify if:
- \- Participants previously diagnosed with amyloidosis cannot be included in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil
Sant Pere de Ribes, Barcelona, 08810, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lidia Tikhomirova, MD
CSAPG
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2024
First Posted
July 30, 2024
Study Start
November 13, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
December 2, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- After publication of main results of the study.
- Access Criteria
- IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
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).