Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage
TRACE-aSAH
The Occurrence of Abdominal Aortic Aneurysms in Patients With Ruptured Intracranial Aneurysms
1 other identifier
observational
233
0 countries
N/A
Brief Summary
Rationale: Aneurysms of different types are known to be associated. In literature, concurrence of intracranial- and aortic aneurysms is described. Screening for aortic aneurysms (AA) in patients with intracranial aneurysms (IA) or aneurysmal subarachnoid haemorrhage (aSAH) could be cost-effective and of significant importance to decrease morbidity and mortality. The available literature on the association between the two types of aneurysms is sparse and in general of poor methodological quality. This protocol presents a study to more adequately evaluate the association between IA and AA. Objective: To investigate the occurrence of abdominal aortic aneurysms (AAA) in patients who experienced aSAH. Study design: This single cohort prospective study will include patients who experienced aSAH. The study participants will receive an abdominal ultrasound of the aorta to detect an AAA. Study population: aSAH patients from a prospective cohort trial in the Netherlands. Main study parameters/endpoints: The primary outcome, which will be investigated in the here above described study population, is the number of AAA detected on abdominal ultrasound. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will not receive an intervention, but only a diagnostic imaging without radiation. The burden associated with this study are considered minimal and the risks negligible. An abdominal ultrasound is a non-invasive diagnostic method with no risks for the participant. The only possible existing burden to the participant is travel and appointment time with a risk of detecting an abdominal aortic aneurysm or other (occult) intra-abdominal pathologies. When an aneurysm, sub-aneurysm or other intra-abdominal pathology is detected, surveillance or treatment according to standard of care and guidelines will follow.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for all trials
Started Jun 2026
Shorter than P25 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2025
CompletedFirst Posted
Study publicly available on registry
December 31, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
Study Completion
Last participant's last visit for all outcomes
December 1, 2026
April 14, 2026
April 1, 2026
6 months
December 2, 2025
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Occurrence of AAA
Main study parameter/endpoint The primary endpoint of this study will be the occurrence rate of AAA in the study population. This occurrence rate will be calculated as the proportion of all performed ultrasounds in the study group (N; %).
1 year
Secondary Outcomes (1)
Risk factors for AAA in aSAH patients
1 year
Study Arms (1)
Patients with aSAH from the SPARTA trial
All aSAH patients from a large prospective cohort trial in the Netherlands will be screened for eligibility(12). The Study on Prognosis of Acutely RupTured Aneurysms (SPARTA) is an observational prospective cohort trial conducted in the Netherlands in several clinical centres. The aim of this study is to evaluate the long-term clinical outcome of aSAH patients who underwent neurosurgical- or endovascular treatment for their ruptured IA. The study has a population of around 900 patients. Because of the lethality of aSAH, a large proportion of this study population will be diseased or heavily incapacitated.
Eligibility Criteria
All aSAH patients from a large prospective cohort trial in the Netherlands will be screened for eligibility(12). The Study on Prognosis of Acutely RupTured Aneurysms (SPARTA) is an observational prospective cohort trial conducted in the Netherlands in several clinical centres. The aim of this study is to evaluate the long-term clinical outcome of aSAH patients who underwent neurosurgical- or endovascular treatment for their ruptured IA. The study has a population of around 900 patients. Because of the lethality of aSAH, a large proportion of this study population will be diseased or heavily incapacitated.
You may qualify if:
- In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- Patient is a study subject of the trial: Study on Prognosis of Acutely RupTured Aneurysms (SPARTA)(12)
- Written informed consent
- By being a study subject of the SPARTA trial, the following criteria are applicable:
- Confirmed diagnosis of SAH on CT-scan or lumbar puncture (in the presence of a negative CT-scan)
- IA related SAH as confirmed with radiological imaging
- Age 18 years or older at presentation
- Written informed consent for the SPARTA-trial
You may not qualify if:
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- Patient is not a study subject of the SPARTA trial
- Patient has Loeys-Dietz-, Marfan- or Ehlers-Danlos syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeroen Brouwers, MD, PhD
Leiden University Medical Centre
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 2, 2025
First Posted
December 31, 2025
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 14, 2026
Record last verified: 2026-04