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

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.

Study Overview

• Status: Unknown
• Conditions: Low Fibrinogen
• Intervention / Treatment: Diagnostic test: F-Point

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.

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Luke Heaphy, BSc; Phone Number: 2540 01 817 2540; Email: lukeheaphy@rcsi.com

Study Locations

• Ireland
  • Dublin 1, Ireland
    • Recruiting
    • Obstetrics & Gynaecology, The Rotunda Hospital
    • Contact: Luke Heaphy, BSc; Phone Number: 01 817 2540; Email: lukeheaphy@rcsi.com
    • Principal Investigator: Patrick Thornton
    • Sub-Investigator: Richard Katz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: F-Point; F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)
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.	Diagnostic test: F-Point; F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)
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.	Diagnostic test: F-Point; F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal College of Surgeons, Ireland
• Collaborators: Enterprise Ireland; Dublin City University
• Investigators: Principal Investigator: Patrick Thornton, Rotunda Hospital

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 14, 2018
• Primary Completion (ANTICIPATED): October 30, 2018
• Study Completion (ANTICIPATED): October 30, 2018

Study Registration Dates

• First Submitted: June 21, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: FPoint-V1-0418

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No