Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests
NCT ID: NCT04375982
Last Updated: 2023-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2020-04-20
2024-03-31
Brief Summary
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Detailed Description
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Agreement of the different sample types to the reference method will be demonstrated across a patient population representative of the indication for use of the products. Operators will be trained clinical site staff who are representative of the intended users of the product, i.e. health care professionals at the point of care such as nurses, technicians, doctors, etc. A panel of whole blood and plasma samples will be obtained from each patient in order to assess the accuracy of the investigative device across all sample types.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Blood collection
Venepuncture and fingerstick to obtain venous blood and capillary blood respectively
Venepuncture
Blood tube will be collected from standard venepuncture
Fingerstick
Capillary blood will be collected by fingerstick
Interventions
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Venepuncture
Blood tube will be collected from standard venepuncture
Fingerstick
Capillary blood will be collected by fingerstick
Eligibility Criteria
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Inclusion Criteria
* Willing and able to provide written informed consent and comply with study procedures.
* Presenting to healthcare provider for any reason\* \*All presentations are suitable for recruitment; however, the following conditions are of particular interest: Venous thromboembolism symptoms (DVT and Pulmonary embolism), subjects seeking medical attention with symptoms of respiratory tract infection (upper or lower), Acute myocardial infarction / unstable angina, Anti-inflammatory medication (current), Any regular medication for a chronic condition (other than simple painkiller or inhaler), Atrial fibrillation, Diabetes mellitus (all types except 'pre-diabetes'), Heart failure, Hypertension (\>150/90), Infection (significant current or within 3 months), Peripheral arterial disease, Surgery (within 6 weeks), Childbirth (within 8 weeks), Significant trauma, burns (within 4 weeks), Pregnancy (confirmed or suspected), Acute upper gastrointestinal haemorrhage other significant recent haemorrhage.
* Subjects \>18 years of age.
* Willing and able to provide written informed consent and comply with study procedures.
* Subjects seeking medical attention with symptoms of infection, tissue injury, inflammatory disorders or associated disease. This includes but not limited to: respiratory tract infection (upper or lower), rheumatoid arthritis, Lupus, burns, trauma, inflammatory bowel disease.
Exclusion Criteria
* Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
* End-stage renal failure on haemodialysis.
* Life expectancy documented as less than 30 days.
* Haemodynamically unstable (e.g. cardiogenic shock).
* Current anticoagulation therapy (Fragmin, LMWH) within the last 30 days.
* Patients taking anticoagulant therapy (DOACS, Warfarin, Heparins etc.) within the last 30 days.
* The subject has previously participated in this research study
* The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic or drug including either treatment or therapy.
* Skin lesions or conditions that would preclude a fingerstick and or a venous blood draw.
* A subject with a critical illness, requiring critical intervention, or end of life or palliative care.
* Subjects suffering with Myeloma, Monoclonal Gammopathy or extreme Lipaemia.
* The subject has previously participated in this research study
18 Years
ALL
Yes
Sponsors
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LumiraDx UK Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Judith Kirstein
Role: PRINCIPAL_INVESTIGATOR
Rancho Paseo Medical Group
Matthew Morgan
Role: PRINCIPAL_INVESTIGATOR
Centura Health Physician Group
Anita Scribner
Role: PRINCIPAL_INVESTIGATOR
Diagnostic Clinic of Longview
William Simon
Role: PRINCIPAL_INVESTIGATOR
New Medical Healthcare
Locations
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Rancho Paseo Medical Group
Banning, California, United States
Centura Health Physician Group
Northglenn, Colorado, United States
New Medical Healthcare
Wichita, Kansas, United States
Diagnostic Clinic of Longview
Longview, Texas, United States
Countries
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Other Identifiers
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S-CLIN-PROT-00027
Identifier Type: -
Identifier Source: org_study_id