Aneurysm AbdominalTRACE-aSAHNCT07312565
Occurrence of Abdominal Aortic Aneurysms in Patients With Aneurysmal Subarachnoid Hemorrhage
An observational study of Aneurysm Abdominal and Cerebral Aneurysm Ruptured, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm Abdominal, Cerebral Aneurysm Ruptured
- How many people
- 233 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Observational
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Occurrence of Abdominal Aortic Aneurysms in Patients With Ruptured Intracranial Aneurysms
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.
Read more
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.
Read the detailed description
This study will be a prospective single cohort study.
During the period of the study, all aSAH patients (from another prospective cohort trial) will be screened for inclusion eligibility. Eligible patients will be included as subjects in this study. Study subjects will receive an abdominal ultrasound (US) focused on the aorta. Detecting an AAA on abdominal US will result in the daily standard of care for AAA, including surveillance and possible treatment by medication, intervention or surgery.
Study sites This study will be conducted by the Department of Surgery in the main study location University Medical Center Leiden (LUMC) in collaboration with University Neurosurgical Center Holland (UNCH). Eligibility screening and inclusion will be performed by the LUMC.
To answer the research questions of this study, the US laboratory of the LUMC will perform US on the included patients.
The clinical (neurovascular) centers who included patients in the SPARTA trial are:
- Haaglanden Medical Centre (HMC)
- Amsterdam Universitary Medical Centre (AUMC)
- Erasmus Medical Centre (EMC)
- Radboud University Medical Centre (Radboudumc)
- University Medical Centre Utrecht (UMCU)
- Maastricht University Medical Centre (MUMC).
The data from the aortic-scan centers will be obtained and centralized analysis will be performed by the main study location LUMC.
Number of study subjects The investigators will include 233 subjects as one single cohort. In this study, the collected data and analysis will be compared to the general- and at-risk population.
Study duration During an initial period of 2 months, patients will be included as study subjects. Inclusion stops when the targeted number of study subjects (N=233) is reached. The study duration is expected to be around 1.5 years and the study period will end when all 233 study subjects had an abdominal US, or were excluded from the study during the study period for particular reasons.
- Conditions
- Aneurysm Abdominal, Cerebral Aneurysm Ruptured
- Keywords
- abdominal aortic aneurysm, aneurysmal subarachnoid hemorrhage, ruptured intracranial aneurysm, prospective single cohort study, ultrasound
- Medical subject headings
- Aortic Aneurysm, Abdominal, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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; %).
Measured: 1 year
Secondary outcomes (1)
Risk factors for AAA in aSAH patients
Secondary study parameters/endpoint As a secondary endpoint, the investigators will evaluate risk factors of having an AAA as an aSAH patient. Presence of these factors (i.e. smoking, aneurysmal disease in medical history, age, gender) will be calculated as the proportion of the total study population (N; %).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start1 Jun 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm AbdominalStudies 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
- Prospective
- Enrolment
- 233 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen J.W.M. Brouwers MD PhD, Leiden University Medical Center
- Investigators
- Jeroen Brouwers, MD, PhD, Principal investigator, Leiden University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07312565
- Sponsor's protocol ID
- NL-009714
- Acronym
- TRACE-aSAH
- Status last verified
- Aug 2026
- First submitted
- 2 Dec 2025
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not decided yet