Status:
COMPLETED
Evaluation of a Standardized Protocol for Thrombin Generation Assay
Lead Sponsor:
Lund University
Collaborating Sponsors:
Shire
Conditions:
Hemophilia A
Eligibility:
MALE
18-65 years
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 mean...
Detailed Description
Main goal The aim is to further improve the inter-laboratory variability for the TGA-CAT (Thrombin generation assay-calibrated automated thrombogram) method by using an elaborate standardization proto...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
April 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 28 2019
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03313531
Start Date
April 15 2017
End Date
January 28 2019
Last Update
January 29 2019
Active Locations (1)
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1
Coagulation Unit, department of translational medicine
Malmo, Sweden, 20502