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Clinical Trial Summary

Using whole blood samples and plasma samples obtained from some hemophilia A patients with inhibitors, the investigators will perform the coagulation assessment in the co-presence of aPCC and factor VIII by comprehensive coagulation assays and flow chamber analysis under blood flow conditions.


Clinical Trial Description

Comprehensive coagulation assays using recently popular rotational thromboelastometry (ROTEM), factor Xa/thrombin/plasmin generation test, and coagulation wave analysis and recently developed flow chamber system under blood flow conditions (T-TAS®) will be used. A bypassing agent, aPCC (Feiba®) and recombinant factor VIII (Advate®) will be added ex vivo to whole blood and plasma samples from patients with hemophilia A with inhibitors to compare with the coagulation effects of aPCC in the presence of factor VIII and those of aPCC in its absence under the conditions close to the physiological condition. Furthermore, the difference in the coagulation effects by the difference in inhibitor epitopes will be examined. ;


Study Design

N/A


Related Conditions & MeSH terms


NCT number NCT02554526
Study type Observational
Source Nara Medical University
Contact Keiji Nogami, MD, PhD
Phone +81-744-29-8881
Email roc-noga@naramed-u.ac.jp
Status Not yet recruiting
Phase N/A
Start date September 2015
Completion date December 2017

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