Status:
UNKNOWN
Evaluation of the LumiraDx Point of Care D-Dimer and CRP Tests
Lead Sponsor:
LumiraDx UK Limited
Conditions:
Embolism and Thrombosis
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A Multicenter Study Conducted to Evaluate the Agreement between Fingerstick Whole Blood, Venous Whole Blood and Plasma Determined on the LumiraDx Point of Care D-Dimer and Point of Care CRP Tests to R...
Detailed Description
The purpose of the study is to gather data to determine agreement between sample types, which together with performance evaluation data will be used to support CE marking under Directive 98/79/EC of t...
Eligibility Criteria
Inclusion
- Inclusion Criteria D-dimer:
- Subjects \>18 years of age.
- 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.
- D-dimer Exclusion Criteria:
- 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.
- 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
- CRP Inclusion criteria:
- 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.
- CRP Exclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04375982
Start Date
April 20 2020
End Date
March 31 2024
Last Update
December 26 2023
Active Locations (4)
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1
Rancho Paseo Medical Group
Banning, California, United States, 92220
2
Centura Health Physician Group
Northglenn, Colorado, United States, 80234
3
New Medical Healthcare
Wichita, Kansas, United States, 67212
4
Diagnostic Clinic of Longview
Longview, Texas, United States, 75605