Clinical trial NCT03623061: F-Point Validation Study
Official 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Fibrinogen
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: Dublin City University
name: Enterprise Ireland
First posted: 2018-08-09
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure

•Group 3 will consist of anonymous patient samples

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.

Detailed description: The area to be investigated is the measurement of blood fibrinogen concentration. The aim is to develop a device which can give a fibrinogen level rapidly and accurately, in order to allow decision making quickly in emergency haemorrhage situations.

Postpartum hemorrhage (PPH) is one of the leading causes of maternal mortality and morbidity throughout the world and is accountable for 27.1% of maternal deaths worldwide according to a recent WHO systematic analysis.1 The confidential enquiry into maternal deaths and morbidity 2012 - 2014 describes 13 deaths from maternal haemorrhage.2 Fibrinogen is an component of the coagulation cascade. It is the principal factor for the final stage of clot formation. The fibrinogen level increases during pregnancy from the first through to third trimester.3 During a PPH this level decreases rapidly, influenced by two principal mechanisms, the loss of the blood itself and the consumption of coagulation factors associated with coagulation activation. Fibrinogen level below 2g/L in the early phase of PPH correlates with subsequent development of severe PPH.4 The conventional laboratory tests (Clauss, PT-derived) are time consuming, and workload intensive for laboratory staff. This has implications in terms of decision making in a rapidly changing clinical environment during a massive PPH. A point of care test, with more rapidly available results at the patient location should improve the speed of decision making based on individual patient data. The focus of this study is to validate the fibrinogen concentration as measured by the F-point device compared to the laboratory standard Clauss fibrinogen. The F-Point is second generation POC device that is compatible with deployment within the emergency room or operating theater. By having rapid access to fibrinogen concentration results, early and individualized treatment can be implemented with the aim of improving patient outcomes, with a possible decrease in unnecessary administration of fibrinogen.

We aim to show equivalent performance between the F-Point device in 3 populations.

1. Healthy non-pregnant females presenting for elective gynaecology surgery
2. Healthy pregnant females presenting for elective caesarean section
3. Anonymised low fibrinogen adult samples from the laboratory

These 3 populations have been chosen to demonstrate device performance in:

1. Normal non-pregnant fibrinogen concentrations
2. Normal term pregnancy fibrinogen levels
3. Low fibrinogen concentrations By demonstrating equivalent and acceptable performance at these 3 fibrinogen concentration ranges, we would expect to show performance of the device to be acceptable for clinical use across the spectrum of patients presenting to maternity hospitals.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Fibrinogen concentration
timeFrame: Within 2 hours of blood drawn
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin 1
country: Ireland
facility: Obstetrics & Gynaecology, The Rotunda Hospital
Study officials:
affiliation: Rotunda Hospital
name: Patrick Thornton
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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 Thromb Haemost. 2007 Feb;5(2):266-73. doi: 10.1111/j.1538-7836.2007.02297.x. Epub 2006 Nov 6.