Evaluating thrombin generation tests for personalized hemophilia treatment
Does the Thrombin Generation Test Performed During the Pharmacokinetic Profile of the Substitutive Factor VIII Bring Benefits to the Personalized Treatment of Pediatric Patients and Adult Hemophilia A Patients Under Prophylaxis ?
NA · Brugmann University Hospital · NCT02803502
This study is testing if a new blood test can help doctors better understand bleeding risks and personalize treatment for children and adults with hemophilia A.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Brugmann University Hospital (other) |
| Locations | 5 sites (Brussels and 4 other locations) |
| Trial ID | NCT02803502 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the thrombin generation test (TGT) in predicting the hemostatic status of pediatric and adult patients with hemophilia A who are on prophylactic treatment. The research aims to establish whether TGT can provide a more accurate assessment of bleeding risk compared to traditional factor VIII level measurements. By analyzing the pharmacokinetic profiles of patients, the study seeks to tailor treatment strategies based on individual thrombin generation results. The goal is to improve clinical outcomes for patients suffering from severe or moderate hemophilia.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with severe or moderate hemophilia who are currently on prophylaxis and experiencing bleeding episodes.
Not a fit: Patients with difficult venous access or those who have had recent surgery, trauma, or acute diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment plans for hemophilia patients, reducing bleeding episodes.
How similar studies have performed: Previous studies have shown promising results with thrombin generation tests in assessing bleeding risk, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with severe or moderate hemophilia, on prophylaxis, and suffering from bleedings. Exclusion Criteria: * Patients with difficult venous access * Patients who have had surgery or trauma in the month before, patients with acute disease (infection, inflammation)
Where this trial is running
Brussels and 4 other locations
- CHU Brugmann — Brussels, Belgium (RECRUITING)
- HUDERF — Brussels, Belgium (RECRUITING)
- Centre Hospitalier Régional de la Citadelle de Liège — Liège, Belgium (RECRUITING)
- CHC de Liège — Liège, Belgium (RECRUITING)
- CHU Liège Sart Tilman — Liège, Belgium (RECRUITING)
Study contacts
- Principal investigator: Anne Demulder, MD — CHU Brugmann
- Study coordinator: Anne Demulder, MD
- Email: Anne.DEMULDER@chu-brugmann.be
- Phone: 024773990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemophilia, thrombin generation test, factor VIII, hemophilia