Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine (NCT04615065) | Clinical Trial Compass
RecruitingNot Applicable
Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine
Netherlands35,000 participantsStarted 2020-09-01
Plain-language summary
Research in acute care faces many challenges, including enrollment challenges, legal limitations in data sharing, limited funding, and lack of singular ownership of the domain of acute care. To overcome some of these challenges, the Center of Acute Care of the University Medical Center Groningen in the Netherlands, has established a de novo data-, image- and biobank named "Acutelines". Acutelines is initiated to improve recognition and treatment of acute diseases and obtain insight in the consequences of acute diseases, including factors predicting its outcome. Thereby, Acutelines contributes to development of personalized treatment and improves prediction of patient outcomes after an acute admission.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria, at least one of the following:
* Triaged as one of highest two triage categories (red or orange) according to the Manchester triage system;
* Triaged as the third highest triage category (yellow) and arrival by EMS of Helicopter Emergency Medical Service (HEMS;
* Shock
* Suspicion of sepsis (based on either physicians' suspicion, Sepsis-2 or Sepsis-3 criteria)
* Acute kidney injury (AKI)
* Anaphylactic reaction
* Syncope
* Intoxication
* Thrombosis
* Pulmonary embolism
* Bleeding while using anti-coagulant drugs
* Gastro-intestinal bleeding
* Electrolyte disturbance
Exclusion Criteria:
* Referred for organ transplantation as recipient
* Transfer from other hospital
* Accidental contact patient material (i.e. internal work-related accident)
While data- and imaging will be collected from all these patients, biomaterials will only be collected from patients fulfilling the first criterion (i.e. triaged as one of highest two triage categories \[red or orange\] according to the Manchester triage system) and from patients with shock or a suspicion of sepsis.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mortality (time and cause)
Timeframe: Until the death of death from any cause, up to 50 years
2
Katz ADL-6 (functioning)
Timeframe: Up to 1 year
3
World Health Organization (WHO) performance status (functioning)
Timeframe: Up to 1 year
4
Karnofsky performance score (functioning)
Timeframe: Up to 1 year
5
Utrecht Activity List (daily activities)
Timeframe: Up to 1 year
6
Short QUestionnaire to ASsess Health-enhancing physical activity (daily activities)