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Acutelines: a Large Data-/Biobank of Acute and Emergency Medicine

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04615065
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hjalmar Bouma
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ewoud ter Avest, MD, PhDJan ter Maaten, MD, PhDBarbara van Munster, MD, PhDHjalmar Bouma, MD, PhD
Principal Investigator Affiliation University Medical Center GroningenUniversity Medical Center GroningenUniversity Medical Center GroningenUniversity Medical Center Groningen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Netherlands
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Disease, Sepsis, Pneumonia, Frailty, Complication of Treatment, Pulmonary Embolism, Thrombosis, Acute Kidney Injury, Electrolyte Disturbance, Hemorrhage, Shock, Polypharmacy, Intoxication by Drug, Emergencies, Urinary Tract Infections, Skin Infection, Syncope, Anaphylaxis, Dyspnea
Study Website: View Trial Website
Additional Details

Acutelines is a prospective biobank including patients with a broad spectrum of acute conditions. Its aim is to facilitate interdisciplinary research on the etiology and development of acute diseases with the aid of systematically collected biomaterials and medical data over various timepoints, both during the course of the patient's disease and after recovery. Clinical data, imaging data and biomaterial (i.e. blood, urine, feces, hair) are collected for patients presenting to the Emergency Department (ED) with a broad range of acute disease presentations. A deferred consent procedure (by proxy), is in place to allow collecting data and biomaterials prior to obtaining written consent. The digital infrastructure in place and the software used ensures automated capturing of all bed-side monitoring data (i.e. electrophysiological waveforms, vital parameters), and the secure importation of data from other sources, such as the electronic health records of the hospital, ambulance and general practitioner, municipal registration, health insurance companies and pharmacy. Follow up data are collected for all included patients during the first 72-hours of their hospitalization and 3-months, 1-year, 2-years and 5 years after their ED visit. Data and materials to be collected includes: - Demographic and health data (i.e. [experiences] health, quality of life, functional status) - Medical history (i.e. co-morbidity, intoxications, medication use) - Admission reason to emergency department - Physical examination and vital parameters - Clinical diagnostic data (i.e. [point-of-care] ultrasound, X-ray, CT-scan, laboratory results) - Electrophysiological waveforms (i.e. electrocardiogram [ECG], plethysmography) - Biomaterials - Treatment (i.e. medication use, non-pharmacological treatment, treatment decisions, length-of-stay in hospital, admission to intensive care unit [ICU])

Contact a Trial Team

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International Sites

University Medical Center Groningen, Groningen, Netherlands

Status

Recruiting

Address

University Medical Center Groningen

Groningen, , 9700 RB

Site Contact

Hjalmar Bouma, MD, PhD

acutelines@umcg.nl

0503616161

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