Biomarker-enhanced ED Disposition Decisions (BANC4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00920491
Recruitment Status : Completed
First Posted : June 15, 2009
Last Update Posted : December 15, 2014
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:

Patients presenting to emergency departments (ED) with non-specific complaints (NSC) such as "not feeling well", "feeling weak", "being tired", "general deterioration" are a very common and well-known, but poorly studied patient group. The differential diagnosis of NSC is extremely broad ranging from insufficient home care to acute life-threatening conditions. Therefore, the evaluation and diagnostic work-up of these mostly elderly patients with NSC is very time-consuming and not straight-forward. Furthermore, the assessment is complicated by comorbidities, polypharmacy or an altered mental status. For this reason, potentially unnecessary diagnostic efforts are undertaken in order to exclude a serious underlying condition, leading to prolonged throughput times and ED observation unit stays.

On the other hand, the patients` condition might be underestimated by ED physicians, which may result in ineffective, delayed or inadequate disposition, as well as poor patient outcomes. BANC (formerly BAUCAS) is a series of clinical studies with the intention to investigate the usefulness of clinical findings and biomarker levels combined for disposition of patients with non-specific complaints presenting to the emergency department.

Condition or disease Intervention/treatment
Non-specific Complaints Biological: biomarker-enhanced disposition decision with proADM

Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: BANC4 (BASEL NON - SPECIFIC COMPLAINTS 4) Biomarker-enhanced Disposition Decisions
Study Start Date : July 2011
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Group/Cohort Intervention/treatment
patients with non-specific complaints
patients who do not have specific presenting symptoms (e.g. dyspnea, chest pain etc.)
Biological: biomarker-enhanced disposition decision with proADM
To compare the outcome of standard of care with an approach combining the standardized course and biomarker levels (biomarker-enhanced disposition decision with proADM) for the disposition of patients with non-specific complaints presenting to the emergency department (ED), in order to evaluate safety.

Primary Outcome Measures :
  1. serious condition (potentially life-threatening or requiring early intervention to prevent health status deterioration) [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 30 day mortality [ Time Frame: 30 days ]

Biospecimen Retention:   Samples Without DNA
whole blood (MR-proADM)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The protocol of the BANC study specifies that patients are consecutively enrolled in order to obtain a random sample of the source population of ED self-referred and referred patients with UC

Inclusion Criteria:

  • All adult non-trauma patients with an Emergency Severity Index (ESI) of 2 or 3 are screened for inclusion

Exclusion Criteria:

  • patients with specific chief complaints are excluded. Moreover, patients in whom an unambiguous and clear working hypothesis with logical management steps can be established are excluded

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00920491

University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Principal Investigator: Roland Bingisser, MD University Hospital, Basel, Switzerland

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: University Hospital, Basel, Switzerland Identifier: NCT00920491     History of Changes
Other Study ID Numbers: ED UHBS
First Posted: June 15, 2009    Key Record Dates
Last Update Posted: December 15, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Basel, Switzerland:
Chief complaint
non-specific symptoms
general weakness / general deterioration
risk assessment in ED patients with non-specific symptoms