Determining how common amyloidosis is in trauma surgery patients
Prevalence of Amyloidosis in Trauma Patients Using Red Flags Tool
Consorci Sanitari de l'Alt Penedès i Garraf · NCT06527521
This study is trying to find out how common amyloidosis is in patients who are about to have trauma surgery by looking for certain warning signs that might show a higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 246 (estimated) |
| Sex | All |
| Sponsor | Consorci Sanitari de l'Alt Penedès i Garraf (other) |
| Locations | 1 site (Sant Pere de Ribes, Barcelona) |
| Trial ID | NCT06527521 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence of amyloidosis in patients scheduled for trauma surgery. It focuses on identifying individuals with specific 'red flags' that may indicate a higher risk of amyloidosis, such as age over 65, family history, and various cardiac and neurological conditions. Participants will be evaluated based on these criteria to better understand the frequency of this condition in a trauma setting.
Who should consider this trial
Good fit: Ideal candidates are men and women over 65 or those with specific health histories that raise suspicion for amyloidosis.
Not a fit: Patients who have already been diagnosed with amyloidosis will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and management of amyloidosis in trauma patients, improving patient outcomes.
How similar studies have performed: While the approach of assessing amyloidosis prevalence in trauma patients is relatively novel, similar studies have indicated the importance of identifying underlying conditions in surgical populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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: \- Participants previously diagnosed with amyloidosis cannot be included in the study.
Where this trial is running
Sant Pere de Ribes, Barcelona
- Consorci Sanitari Alt Penedes i Garraf-Hospital Sant Camil — Sant Pere de Ribes, Barcelona, Spain (RECRUITING)
Study contacts
- Principal investigator: Lidia Tikhomirova, MD — CSAPG
- Study coordinator: Lidia Tikhomirova, MD
- Email: ltikhomirova@csapg.cat
- Phone: +34 938960025
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amyloidosis, Red Flags tool, Traumatology