NCT06357572Completed
Real-life Clinical FEIBA Samples Measured Using the Version A of the HemA EnzySystem
Source: ClinicalTrials.gov · Last updated 10 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 6 (actual)
- First submitted
- 5 Apr 2024
- Start date
- Mar 2024
- Primary completion date
- Mar 2024
- Lead sponsor
- Enzyre B.V.
- Diseases
- Haemophilia
- NCT number
- NCT06357572
What you commit to
- Study type: Observational
- Participants enrolled: 6
- From Mar 2024 to the primary completion date, Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of:
- NSAIDs; antimicrobial medication; thyroid inhibitors or SSRI's;
Other illness
- known allergy to stainless steel;
- a bleeding episode within the last two weeks;
- Signs of inflammation or infection
Lab values
- use of anticoagulants or platelet antagonists (aspirin or any TAR);
- clinical indication of liver cirrhosis (ultrasonography indication, enlarged spleen, decreased platelet count \<100 G/l);
Who the study is looking for
- Diagnosed with mild (FVIII activity levels 5-40%), moderate (FVIII activity levels 1-5%) or severe hemophilia A (FVIII activity levels \<1%)
- With inhibitors
- On prophylactic or on-demand treatment with FEIBA (variation in dosing and duration of therapy use)
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institute of Hematology and Blood Transfusion Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.