Evaluating the effect of Emicizumab on clotting time in hemophilia A patients
Impact of Emicizumab on ACT (Activated Clotting Time) Using the i-STAT Alinity Analyzer: In Vitro Study in Severe Hemophiliacs A and Healthy Volunteers
This study is testing how the treatment Emicizumab affects clotting time in people with severe hemophilia A to see if it changes how their blood clots during surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Hospital, Grenoble Academic / other |
| Drugs / interventions | emicizumab |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT05856903 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how Emicizumab, a treatment for severe hemophilia A, affects activated clotting time (ACT) as measured by the i-STAT Alinity Analyzer. The study aims to understand the implications of Emicizumab on coagulation tests used during cardiac procedures, particularly those involving heparin therapies. By monitoring the ACT, researchers hope to determine if Emicizumab alters the intrinsic pathway of coagulation, which could impact clinical practices in managing hemophilia A patients undergoing surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are severe hemophilia A patients who have been on Emicizumab treatment for more than four weeks.
Not a fit: Patients who have received factor VIII infusions within the last five days or those on anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and efficacy of coagulation monitoring in hemophilia A patients undergoing cardiac procedures.
How similar studies have performed: While the use of Emicizumab in hemophilia A is established, the specific evaluation of its impact on ACT in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * severe hemophiliacs under emicizumab ( \> 4 weeks) Exclusion Criteria: * infusion of factor VIII \< 5 days * patients refusing to participate in the study * protected persons * anticoagulants
Where this trial is running
Grenoble
- Grenoble University Hospital — Grenoble, France (Recruiting)
Study contacts
- Principal investigator: Raphaël MARLU, MD — Grenoble Alpes University Hospital
- Study coordinator: Raphaël MARLU, MD
- Email: rmarlu@chu-grenoble.fr
- Phone: 33476765487
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.