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

NCT06357572 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2024-04-10

No results posted yet for this study

Summary

The goal of this observational study is to assess if the version A of the HemA EnzySystem, a novel portable coagulation testing platform, can be used in patients with hemophilia A treated with Factor VIII Bypassing Agent (FEIBA). The main question\[s\] it aims to answer are:

* Can the version A of the HemA EnzySystem can record thrombin generation within a time frame of 60 min in fresh whole blood samples of patients with hemophilia A treated with FEIBA?
* Are the TGA results of the version A of the HemA EnzySystem in agreement with the TGA results obtained with conventional methods in fresh non frozen plasma?

Participants are asked to fill in a questionnaire regarding their general health and hemophilia treatment. Subsequently, blood will be drawn from the patients before, and at 30, 120, and 240 minutes after FEIBA administration. Whole blood is immediately tested using the Version A HemA EnzySystem, and plasma is generated for testing with the Ceveron s100 (Technoclone). Leftover samples are frozen for later additional coagulation testing.

Conditions

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

Sponsors & Collaborators

  • Instytut Hematologii i Transfuzjologii, Warschau, Poland

    collaborator UNKNOWN

  • Enzyre B.V.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-26
Primary Completion
2024-03-27
Completion
2024-03-27

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06357572 on ClinicalTrials.gov