Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2019-07-01
2021-06-30
Brief Summary
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The clinical development of such molecules requires a dedicated biological monitoring. Thrombin Generation Assay (TGA) in Poor Platelets Plasma (PPP) is a good candidate since it is sensitive to Factor VIII and Factor IX deficiencies as well as to TFPI. However, TGA results are very dependent on experimental conditions (i. e. Tissue Factor and phospholipids concentrations) and the relationship between TFPI plasma level and TGA parameters has not been studied yet. This study should provide with original data on TFPI plasma levels and the effect of TFPI on thrombin generation in haemophilia patients. This should help to define the monitoring of TFPI inhibitors in Haemophilia.
Detailed Description
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If blood tests are prescribed during the consultation, the unused plasma samples that are not required to perform the prescribed analyses will be collected and anonymized in order to measure the TGA and TFPI levels.
TFPI plasmatic level and TFPI activity measurements will be performed by a quantitative ELISA assay (Total TFPI ELISA kit®, R\&d Systems) and a chromogenic assay (Actichrom TFPI®, Cryopep) respectively.
TGA will be performed on a Fluoroskan® machine using 3 different levels of Tissue Factor (TF): 1, 5 and 20 pM. In order to study the relation between different levels of TFPI inhibitors and TGA parameters, TGA will also be performed by spiking blood samples with several concentrations of TFPI inhibitor. For each TGA performed, ETP (Endogenous Thrombin Potential, nM/min), peak (nM) and lagtime (min) will be analyzed.
Clinical data will be collected from the computerized patient record: date of birth, age, gender, haemophilia type (A or B) and its severity, ongoing treatments and deficient factor level.
The goal of this study is to measure the TFPI plasma level in haemophilia patients. The second objective is to assess the effects of TFPI inhibition on thrombin generation. This study should provide with original data on TFPI plasma levels and the effect of TFPI on thrombin generation in haemophilia patients. This should help to define the monitoring of TFPI inhibitors in Haemophilia.
There is no additional risk for the patient since only unused blood samples, not needed for the prescribed blood tests, will be collected.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult haemophilia patients
Adult (≥ 18 years old) haemophilia patients, only men
NON INTERVENTIONAL
NON INTERVENTIONAL
Interventions
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NON INTERVENTIONAL
NON INTERVENTIONAL
Eligibility Criteria
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Inclusion Criteria
* Follow-up consultation in our center
Exclusion Criteria
* No blood samples collection planed during the follow-up consultation
18 Years
MALE
No
Sponsors
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CHU de Reims
OTHER
Responsible Party
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Locations
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Damien JOLLY
Reims, , France
Countries
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Central Contacts
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Facility Contacts
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Philippe NGUYEN
Role: primary
Other Identifiers
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PO19085
Identifier Type: -
Identifier Source: org_study_id