Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Decision-making - the Benefit of Bedside CRP Within Ambulance Care (Q-CRP)

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.
 
ClinicalTrials.gov Identifier: NCT04097210
Recruitment Status : Completed
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Marja Mäkinen, Helsinki University Central Hospital

Tracking Information
First Submitted Date November 26, 2018
First Posted Date September 20, 2019
Last Update Posted Date September 20, 2019
Actual Study Start Date January 1, 2016
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 19, 2019)
Number of patients with high suPAR level [ Time Frame: 24 hours ]
A high suPAR level, e.g. above 6 ng/ml
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Decision-making - the Benefit of Bedside CRP Within Ambulance Care
Official Title When Triage is Insufficient - the Benefit of Bedside CRP Within Ambulance Care
Brief Summary Patients with degreased (DGC) for ambiguous reasons receive low triage priority. Their death risk is triple. Tools are needed to identify the critically ill patients from this group. The triage used today is not effective. The bedside point-of-care measurements are CRP, lactate acid and suPAR (Soluble Urokinase Plasminogen Activator Receptor). Elevated values associate with the probability of critical illness and predict a risk of death.
Detailed Description

Purpose: To improve identification and proper prioritization of patients with non-specific symptoms prehospitally, we intend to investigate whether Q-CRP, a rapid test for CRP, correlates with time-critical states in the above-mentioned patient group alone or together with CRP, lactate and suPAR. The primary endpoint is need for hospital care.

Material: Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Method: In patients with unspecified conditions, defined according to the inclusion template, a venous blood sample was taken prehospitally at the scene by the EMS.

Analysis: Significance tests and regression analyzes with 95% CI were used. The diagnostic accuracy of Q-CRP, lactate, suPAR and combinations thereof were compared with optimal boundary values.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
No biospecimen banking
Sampling Method Non-Probability Sample
Study Population Patients with degreased condition (DGC) over 18 years who exhibit non-specific symptoms and transported to the emergency room.
Condition Critical Illness
Intervention Diagnostic Test: POC
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 19, 2019)
110
Original Actual Enrollment Same as current
Actual Study Completion Date September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients over 18 years who exhibit non-specific symptoms and transported to the emergency room.

Exclusion Criteria:

  • Abnormal vitals
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years to 104 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT04097210
Other Study ID Numbers HUS 329/13/3/02/2015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Marja Mäkinen, Helsinki University Central Hospital
Study Sponsor Helsinki University Central Hospital
Collaborators Not Provided
Investigators
Study Director: Maaret Castrén, Professor Helsinki University Central Hospital
Principal Investigator: Johanna Kaartinen, PhD Helsinki University Central Hospital
PRS Account Helsinki University Central Hospital
Verification Date November 2018