- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02300519
Thrombin Generation Numerical Models Validation in Haemophilic Case
12 augusti 2015 uppdaterad av: Centre Hospitalier Universitaire de Saint Etienne
Personalized therapy in haemophilia has not been reached yet.
Treatment is substitutive and its doses are only based on the levels of deficient factor VIII (for haemophilia A) or IX (for haemophilia B).
The bleeding severity is not only related to the factor deficiency but also to levels of other coagulation factors (e.g.
factor X, II, AT or TFPI).
It's necessary to take them into account in order to individualize treatments; and Thrombin Generation Assay (TGA) with the CAT method (Calibrated Automated Thrombography) is a good way because it measures the result of the coagulation cascade.
TGA on Platelet Rich Plasma (PRP) is even closer to physiological conditions than on Platelet Poor Plasma (PPP) because platelet influence is represented.
It has already been shown (at least in PPP) that the bleeding tendency in haemophilic patients is usually well correlated to TG.
Some TG parameters are used to characterize the individual coagulation phenotype, the most important being the Endogenous Thrombin Potential (ETP) and the Lag Time (LT).
A hemorrhagic profile usually provides a longer lag time and / or a lower ETP.
However, only few studies tried to determine the influence of each coagulation factor and inhibitor on TG.
They were done on Platelet Poor Plasma (PPP) or on lyophilized plasma.
So the relation between coagulation factors and the different TG parameters remains to be determined, especially in the haemophilic case.
It is possible, experimentally, to find the optimal dose of the factor to be added by measuring TG in samples with different factor VIII or IX concentrations, but this method would be time consuming and expensive, especially because it should be done for each haemophilic patient.
A better way consists in using TG numerical models.
For a set of initial factor levels they simulate the TG and its associated parameters.
It is now essential to validate the existing models, especially in haemophilic cases, in order to see whether they are reliable and can be used in clinical practice afterwards.The objective of this study is to validate thrombin generation numerical models which could predict the factor VIII or IX activity correction to reach a thrombin generation sufficient to avoid bleeding.
A comparison between the TG observed in haemophilic patients and the TG predicted by the models is needed to validate the models.
In order to define a 'safe' TG i.e. sufficient to avoid bleeding, normal ranges of TG parameters have to be measured.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
40
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Saint-Etienne, Frankrike, 42055
- CHU Saint-Etienne
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
volunteers witch work in CHU Saint-Etienne
Beskrivning
Inclusion Criteria:
- Signed consent form
- Age between 18 and 45 years old
- Male
- no smoker
Exclusion Criteria:
- other clinical research protocol participation during the 3 months before inclusion
- Personal or familial history of hemorrhagic disease (parents, brothers and sisters
- Personal history of thrombosis (arterial or venous)
- Familial history of thrombosis before 45 years old (parents, brothers and sisters)
- Drug treatments of aspirin or anti-inflammatory type during the week before sampling
- Surgery the month before sampling
- Chronic pathology responsible for inflammatory syndrome
- Infectious episode in course
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Volunteers
Blood sampling : 1 blood punction of 36.5 ml for each volunteer
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Samplings will be taken on 4 citrated S-monovette tubes, 3 citrated tubes and 1 EDTA tube, namely 36.5 ml for each volunteer
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Endogenous Thrombin Potential (ETP) predicted by numerical models
Tidsram: up to 12 monthes
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ETP (i.e. the aera under the thrombin generation curve, nM.min)
measured in haemophilic patients is compared to ETP predicted by numerical models.
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up to 12 monthes
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Lag Time of the thrombin generation curve predicted by numerical models
Tidsram: up to 12 monthes
|
Lag time (min) measured in haemophilic patients is compared to the lag time predicted by numerical models
|
up to 12 monthes
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Peak value of the thrombin generation curve predicted by numerical models
Tidsram: up to 12 monthes
|
Peak value (nmol thrombin) measured in haemophilic patients is compared to the peak value predicted by numerical models
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up to 12 monthes
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Time to peak (TTP) of the thrombin generation curve predicted by numerical models
Tidsram: up to 12 monthes
|
TTP (min) measured in haemophilic patients is compared to TTP predicted by numerical models
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up to 12 monthes
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Velocity Index (V) of the thrombin generation curve predicted by numerical models
Tidsram: up to 12 monthes
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Velocity Index measured in haemophilic patients is compared to TTP predicted by numerical models
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up to 12 monthes
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Endogenous Thrombin Potential (ETP) for volunteers
Tidsram: day 1
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ETP (i.e. the aera under the thrombin generation curve, nM.min) is measured by Thromboplastin Generation Tests (TGTs)
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day 1
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Lag Time of the thrombin generation curve for volunteers
Tidsram: day 1
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Lag time (min) of the thrombin generation curve is measured by Thromboplastin Generation Tests (TGTs)
|
day 1
|
Peak value of the thrombin generation curve for volunteers
Tidsram: day 1
|
Peak value of the thrombin generation curve is measured by Thromboplastin Generation Tests (TGTs)
|
day 1
|
Time to peak (TTP) of the thrombin generation curve for volunteers
Tidsram: day 1
|
TTP of the thrombin generation curve is measured by Thromboplastin Generation Tests (TGTs)
|
day 1
|
Velocity Index (V) of the thrombin generation curve for volunteers
Tidsram: day 1
|
Velocity Index (V) of the thrombin generation curves measured by Thromboplastin Generation Tests (TGTs)
|
day 1
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Brigitte TARDY-PONCET, MD, CHU Saint-Etienne
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2015
Primärt slutförande (Faktisk)
1 juli 2015
Avslutad studie (Faktisk)
1 juli 2015
Studieregistreringsdatum
Först inskickad
18 november 2014
Först inskickad som uppfyllde QC-kriterierna
21 november 2014
Första postat (Uppskatta)
25 november 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
13 augusti 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 augusti 2015
Senast verifierad
1 augusti 2015
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1408185
- 2014-A01734-43 (Annan identifierare: ANSM - FRANCE)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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