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Trial record 2 of 34292 for:    POINT

F-Point Validation Study (F-Point)

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ClinicalTrials.gov Identifier: NCT03623061
Recruitment Status : Recruiting
First Posted : August 9, 2018
Last Update Posted : August 9, 2018
Sponsor:
Collaborators:
Dublin City University
Enterprise Ireland
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

June 21, 2018
August 9, 2018
August 9, 2018
May 14, 2018
October 30, 2018   (Final data collection date for primary outcome measure)
Measurement of Fibrinogen concentration [ Time Frame: Within 2 hours of blood drawn ]
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.
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
F-Point Validation Study
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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure

•Group 3 will consist of anonymous patient samples

Low Fibrinogen
Diagnostic Test: F-Point
F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)
  • 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.
    Intervention: Diagnostic Test: F-Point
  • 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.
    Intervention: Diagnostic Test: F-Point
  • 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.
    Intervention: Diagnostic Test: F-Point

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Same as current
October 30, 2018
October 30, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Not Provided
Contact: Luke Heaphy, BSc 01 817 2540 ext 2540 lukeheaphy@rcsi.com
Ireland
 
 
NCT03623061
FPoint-V1-0418
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Royal College of Surgeons, Ireland
Royal College of Surgeons, Ireland
  • Dublin City University
  • Enterprise Ireland
Principal Investigator: Patrick Thornton Rotunda Hospital
Royal College of Surgeons, Ireland
August 2018