F-Point Validation Study
F-Point
A Clinical Study to Define Precision, Accuracy, and Comparability of Results From a Novel Point of Care Fibrinogen Assay (F-Point), Compared to an Industry Standard
1 other identifier
observational
150
1 country
1
Brief Summary
The F-Point investigation is an open label, single centre prospective observational study in 3 cohorts of patients, one with low fibrinogen concentration, one with normal fibrinogen concentration, and one with high fibrinogen concentration To show statistical agreement between the fibrinogen level as recorded by the standard lab Clauss fibrinogen, and the fibrinogen level as recorded by the novel F-Point device.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2018
CompletedFirst Submitted
Initial submission to the registry
June 21, 2018
CompletedFirst Posted
Study publicly available on registry
August 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2018
CompletedAugust 9, 2018
August 1, 2018
6 months
June 21, 2018
August 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Measurement of Fibrinogen concentration
To demonstrate equivalent performance between a novel point of care device, the F-point, when compared to the laboratory Clauss assay for measuring fibrinogen concentration.
Within 2 hours of blood drawn
Study Arms (3)
Low Fibrinogen Level
Anonymised low fibrinogen adult samples from the laboratory (Low fibrinogen concentrations). Samples to be tested on the F-Point device and standard Clauss Fibrinogen assay.
Normal Fibrinogen Level
Healthy non pregnant females presenting for elective gynaecology surgery (Normal non pregnant fibrinogen concentrations) Samples to be tested on the F-Point device and standard Clauss Fibrinogen assay.
High Fibrinogen Level
Healthy pregnant females presenting for elective caesarean section (Normal term pregnancy fibrinogen levels) Samples to be tested on the F-Point device and standard Clauss Fibrinogen assay.
Interventions
F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)
Eligibility Criteria
Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure •Group 3 will consist of anonymous patient samples
You may qualify if:
- Participant is willing and able to give informed consent for participation in the clinical investigation.
- Female, aged 18 years or above.
- Able (in the Investigators opinion) and willing to comply with all clinical investigation requirements.
- Presenting for Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure
- Group 3 will consist of anonymous patient samples
You may not qualify if:
- Patients on any antiplatelet or anticoagulant medications
- o Patients prescribed subcutaneous low molecular weight heparin medications are permitted to enrol, provided the timing of sampling is outside of 24 hours after the last dose of the medication.
- Any patient with a known thrombophilia or a known haemophilia.
- Any patient with a known dysfibrinogenaemia except in the anonymous low fibrinogen group
- Patients with a known malignancy or autoimmune condition affecting blood clotting
- A personal history of easy bruising strongly suggestive of a blood clotting disorder
- Any reason, in the opinion of the investigator that would make the subject unsuitable for participation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royal College of Surgeons, Irelandlead
- Dublin City Universitycollaborator
- Enterprise Irelandcollaborator
Study Sites (1)
Obstetrics & Gynaecology, The Rotunda Hospital
Dublin, Ireland
Related Publications (3)
Say L, Chou D, Gemmill A, Tuncalp O, Moller AB, Daniels J, Gulmezoglu AM, Temmerman M, Alkema L. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33. doi: 10.1016/S2214-109X(14)70227-X. Epub 2014 May 5.
PMID: 25103301RESULTGong JM, Shen Y, He YX. Reference Intervals of Routine Coagulation Assays During the Pregnancy and Puerperium Period. J Clin Lab Anal. 2016 Nov;30(6):912-917. doi: 10.1002/jcla.21956. Epub 2016 Apr 7.
PMID: 27061783RESULTCharbit B, Mandelbrot L, Samain E, Baron G, Haddaoui B, Keita H, Sibony O, Mahieu-Caputo D, Hurtaud-Roux MF, Huisse MG, Denninger MH, de Prost D; PPH Study Group. The decrease of fibrinogen is an early predictor of the severity of postpartum hemorrhage. J Thromb Haemost. 2007 Feb;5(2):266-73. doi: 10.1111/j.1538-7836.2007.02297.x. Epub 2006 Nov 6.
PMID: 17087729RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Thornton
Rotunda Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2018
First Posted
August 9, 2018
Study Start
May 14, 2018
Primary Completion
October 30, 2018
Study Completion
October 30, 2018
Last Updated
August 9, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share