Low Fibrinogen Clinical Trial
— F-PointOfficial title:
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
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 30, 2018 |
Est. primary completion date | October 30, 2018 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | Obstetrics & Gynaecology, The Rotunda Hospital | Dublin 1 |
Lead Sponsor | Collaborator |
---|---|
Royal College of Surgeons, Ireland | Dublin City University, Enterprise Ireland |
Ireland,
Charbit 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 — View Citation
Gong 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. — View Citation
Say L, Chou D, Gemmill A, Tunçalp Ö, Moller AB, Daniels J, Gülmezoglu 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. Re — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |