Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem

CompletedOBSERVATIONAL
Enrollment

6

Participants

Timeline

Start Date

March 26, 2024

Primary Completion Date

March 27, 2024

Study Completion Date

March 27, 2024

Conditions
Hemophilia A With InhibitorHemophilia A
Interventions
DIAGNOSTIC_TEST

Thrombin generation assay (EnzySystem HemA version A - whole blood)

Whole blood obtained by venipuncture is immediately tested with the EnzySystem HemA version A), before and 0, 30, 120 and 240 minutes after administration of FEIBA.

DIAGNOSTIC_TEST

Thrombin generation assay (Ceveron s100 (Technoclone) - fresh plasma)

Whole blood is centrifuged to obtain plasma. The fresh plasma is tested using the Ceveron s100.

DIAGNOSTIC_TEST

Additional coagulation tests

"Plasma samples are frozen for later coagulation testing. The following tests are performed:~Factor VIII activity von Willebrand Factor antigen levels von Willebrand Factor ristocetin activity levels Prothrombin Fragment 1+2 levels ADAMTS13 activity FVIII antigen levels Nijmegen Hemostasis Assay"

Trial Locations (1)

Unknown

Institute of Hematology and Blood Transfusion, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Instytut Hematologii i Transfuzjologii, Warschau, Poland

UNKNOWN

lead

Enzyre B.V.

INDUSTRY

NCT06357572 - Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem | Biotech Hunter | Biotech Hunter