Low FibrinogenF-PointNCT03623061
F-Point Validation Study
An observational study of Low Fibrinogen, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Low Fibrinogen
- What is being tested?
- F-Point
- How many people
- 150 participants
- Where
- 1 siteIreland
- Study dates
- 14 May 2018to 30 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure •Group 3 will consist of anonymous patient samples
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Ireland1 site, 1 recruiting
- Recruiting
Obstetrics & Gynaecology, The Rotunda Hospital
Dublin
Luke Heaphy, BSc, 01 817 2540, lukeheaphy@rcsi.com
Patrick Thornton
About this 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
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.
Read the 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.
- Healthy non-pregnant females presenting for elective gynaecology surgery
- Healthy pregnant females presenting for elective caesarean section
- Anonymised low fibrinogen adult samples from the laboratory
These 3 populations have been chosen to demonstrate device performance in:
- Normal non-pregnant fibrinogen concentrations
- Normal term pregnancy fibrinogen levels
- 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.
- Conditions
- Low Fibrinogen
- Being tested
- F-Point
- Medical subject headings
- Afibrinogenemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-PointDiagnostic test
F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: F-Point |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 hours of blood drawn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start14 May 2018
- Primary completion30 Oct 2018 (estimated)
- Study completion30 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low FibrinogenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal College of Surgeons, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Dublin City University, Enterprise Ireland
- Responsible party
- Sponsor
- Investigators
- Patrick Thornton, Principal investigator, Rotunda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623061
- Sponsor's protocol ID
- FPoint-V1-0418
- Acronym
- F-Point
- Status last verified
- Aug 2018
- First submitted
- 21 Jun 2018
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 25103301Gong 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.
PubMed 27061783Charbit 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.
PubMed 17087729
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03623061
- Acronym / sponsor ID
- F-Point / FPoint-V1-0418
- Conditions
- Low Fibrinogen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal College of Surgeons, IrelandUniversity, hospital or other
- Collaborators
- Dublin City University, Enterprise Ireland
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 30 Oct 2018 (estimated)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- Healthy non-pregnant females presenting for elective gynaecology surgery
- Healthy pregnant females presenting for elective caesarean section
- Anonymised low fibrinogen adult samples from the laboratory
These 3 populations have been chosen to demonstrate device performance in:
- Normal non-pregnant fibrinogen concentrations
- Normal term pregnancy fibrinogen levels
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Fibrinogen Level | – | Diagnostic Test: F-PointAnonymised 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 | – | Diagnostic Test: F-PointHealthy 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 | – | Diagnostic Test: F-PointHealthy 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Group 1: Elective Caesarean section Group 2: Elective gynaecological procedure •Group 3 will consist of anonymous patient samples
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| F-PointF-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration) | Diagnostic test | High Fibrinogen Level, Low Fibrinogen Level, Normal Fibrinogen Level |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Results publication: PubMed 25103301Say 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.
- Results publication: PubMed 27061783Gong 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.
- Results publication: PubMed 17087729Charbit 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Thornton principal investigator
Rotunda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Fibrinogen, run by Royal College of Surgeons, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Heaphy, BSc (01 817 2540 ext. 2540, lukeheaphy@rcsi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Fibrinogen concentration (time frame: Within 2 hours of blood drawn). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03623061, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2018.