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Evaluation of a Standardized Protocol for Thrombin Generation Assay

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03313531
Recruitment Status : Completed
First Posted : October 18, 2017
Last Update Posted : January 29, 2019
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Lund University

Brief Summary:
This study is aims at determining the inter laboratory variation when using the thrombin generation assay calibrated automated thrombogram (TGA CAT). It is thus, not a clinical trial in its usual meaning. However, to achieve relevant test samples one patient will be treated with two different study drugs as part of the trial and therefore, approval by Läkemedelsverket is needed. Test plasma samples will be sent out to five participating centers in the Scandinavian countries (Gothenburg and Stockholm, Sweden, Århus Denmark, Oslo Norway and Helsinki Finland) and coefficients of variance (CV) and level of agreement will be analyzed. To obtain representative plasma samples with a wide range of thrombin generation capacity (TGC), blood samples will be collected from research persons that has given informed consent to participate in the study. To obtain plasma with low TGC, blood samples will be drawn from patients with severe hemophilia (n=4)(study group 1), to obtain plasma with normal TGC, blood samples will be drawn from healthy volunteers (n=3)(study group 2) and to obtain plasma with high TGC, plasma will be collected from healthy volunteers (n=3)(study group 3) that at previous measurements have been shown to have a TGC>2SD of the median of the control population. Moreover, one patient with severe hemophilia A (HA) will be treated with two factor FVIII concentrates, one with standard half- life (Advate™) and one with a pro-longed half-life (Adynovate™) at two separate occasions (Treated HA person). By taking repeated blood samples after administration, samples with a wide range of FVIII levels and TGC:s will be obtained. Moreover, the effect of using plasmas with low, normal and high TGC for normalization will be investigated. Plasma samples will be collected as soon as approval from the Swedish medical agency (SMA) has been obtained, we count on sending them to participating centers March 2017. All laboratory measurements, data analysis and report writing will be concluded before December 31 2017.

Condition or disease Intervention/treatment
Hemophilia A Diagnostic Test: Thrombin Generation Assay Drug: Treatment with recombinant coagulation factor

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Other
Time Perspective: Other
Official Title: Calibrated Automated Thrombogram: A Scandinavian Multicenter Study
Actual Study Start Date : April 15, 2017
Actual Primary Completion Date : January 28, 2019
Actual Study Completion Date : January 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Group/Cohort Intervention/treatment
Study group 1
Patients with severe hemophilia A
Diagnostic Test: Thrombin Generation Assay
Inter lab variation and level of agreement will be determined

Study group 2
Healthy volunteers
Diagnostic Test: Thrombin Generation Assay
Inter lab variation and level of agreement will be determined

Study group 3
Healthy volunteers ) that at previous measurements have been shown to have a TGC>2SD of the median of the control population.
Diagnostic Test: Thrombin Generation Assay
Inter lab variation and level of agreement will be determined

Treated HA person
One patient with severe hemophilia A (HA) will be treated with two factor FVIII concentrates, one with standard half- life (Advate™) and one with a pro-longed half-life (Adynovate™) at two separate occasions
Diagnostic Test: Thrombin Generation Assay
Inter lab variation and level of agreement will be determined

Drug: Treatment with recombinant coagulation factor
To obtain a wide range of thrombingeneration levels, one person (Treated HA person) will recieve one injection of Advate and one injection of Adynovate respectively




Primary Outcome Measures :
  1. Inter lab variability [ Time Frame: May 2017 ]
    Coefficient of Variation (CV) i plasma samples with high, normal and low thrombin genration capacity

  2. Inter lab variability [ Time Frame: May 2017 ]
    Coefficient of Variation (CV) i plasma samples from a patient treated with Advate

  3. Inter lab variability [ Time Frame: May 2017 ]
    Coefficient of Variation (CV) and level of agreement i plasma samples from a patient treated with Adynovate


Secondary Outcome Measures :
  1. Inter lab variability [ Time Frame: May 2017 ]
    Coefficient of Variation (CV) and level of agreement when results have been noramlized with plasma with high, normal and low thrombin generation capacity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient with severe hemophilia A
Criteria

Inclusion Criteria:

  • For patients with severe hemophilia A (study group 1)(n=4) that has not received any factor concentrate within 72 hours: Diagnosis of severe hemophilia, with regular check-ups at the hemophilia center at SUS, Malmö and willingness to participate
  • For healthy controls (n=3) (study group 2): Willingness to participate
  • For healthy controls with a documented high TGC (study group 3): Willingness to participate

Exclusion Criteria

  • For patients with severe hemophilia A (study group 1)(n=4) that has not received any factor concentrate within 72 hours: Intake of any other pharmaceutical product known to have an effect on the coagulation system the last 14 days, to the judgement of the including investigator
  • For healthy controls (n=3) (study group 2): Any disorder known to affect the coagulation system and intake of any drug known to affect the coagulation system the last 14 days before blood sampling , to the judgement of the including investigator.
  • For healthy controls with a documented high TGC (study group 3): Any disorder known to affect the coagulation system and intake of any drug known to affect the coagulation system within the last 14 days before blood sampling, to the judgement of the including investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313531


Locations
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Sweden
Coagulation Unit, department of translational medicine
Malmo, Sweden, 20502
Sponsors and Collaborators
Lund University
Shire
Investigators
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Study Director: Jan Astermark, MD PhD Department of hematology, Skane University hospital
Publications:

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Responsible Party: Lund University
ClinicalTrials.gov Identifier: NCT03313531    
Other Study ID Numbers: TGA1
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Lund University:
Thrombin generation
variability
level of agreement
hemophilia
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Thrombin
Hemostatics
Coagulants